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Does peritoneal perforation affect short- and long-term outcomes after transanal endoscopic microsurgery?

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Background: Peritoneal perforation (PP) is frequently reported as a complication of transanal endoscopic microsurgery (TEM). Nevertheless, these concerns have only rarely been addressed in the literature, with no mention of the long-term oncologic consequences of PP. Methods: A prospective database was analyzed with the intent to evaluate the influence of PP on the short- and long-term outcomes for patients undergoing TEM. Results: Peritoneal perforation occurred in 28 (5.8%) of 481 patients who underwent TEM for a rectal neoplasm. The conversion rate to abdominal surgery was 10.7% (3/28). All the conversions occurred during the first 100 TEM procedures (3/100 vs 0/381; p = 0.007). The postoperative morbidity rate was 3.6% (1/28), and the 30-day mortality was nil. Compared with the group of patients who had no peritoneal perforation, the PP group showed a significantly longer operating time (120 vs 60 min; p < 0.001) and a significantly longer hospital stay (6 vs 4 days; p = 0.003). Nevertheless, the global morbidity rate and the type of complications according to Dindo's classification were similar. In the multivariate analysis, the only independent predictor of PP was tumor distance from the anal verge (p = 0.010). During a median follow-up period of 48 months (range, 12-150 months), no liver or peritoneal metastases were detected in 13 patients with rectal cancer. Conclusions: Peritoneal perforation does not seem to affect short-term or oncologic outcomes for patients submitted to TEM with full-thickness resection for upper rectum neoplasms. The use of TEM to resect rectal lesions involving the intraperitoneal rectum may therefore represent an intermediate step toward the development of transrectal natural orifice translumenal endoscopic surgery (NOTES) techniques.
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Does peritoneal perforation affect short- and long-term outcomes
after transanal endoscopic microsurgery?
Mario Morino Marco Ettore Allaix
Federico Famiglietti Mario Caldart
Alberto Arezzo
Received: 4 February 2012 / Accepted: 21 May 2012 / Published online: 21 June 2012
ÓSpringer Science+Business Media, LLC 2012
Abstract
Background Peritoneal perforation (PP) is frequently
reported as a complication of transanal endoscopic micro-
surgery (TEM). Nevertheless, these concerns have only
rarely been addressed in the literature, with no mention of
the long-term oncologic consequences of PP.
Methods A prospective database was analyzed with the
intent to evaluate the influence of PP on the short- and
long-term outcomes for patients undergoing TEM.
Results Peritoneal perforation occurred in 28 (5.8 %) of
481 patients who underwent TEM for a rectal neoplasm.
The conversion rate to abdominal surgery was 10.7 %
(3/28). All the conversions occurred during the first 100
TEM procedures (3/100 vs 0/381; p=0.007). The postop-
erative morbidity rate was 3.6 % (1/28), and the 30-day
mortality was nil. Compared with the group of patients who
had no peritoneal perforation, the PP group showed a sig-
nificantly longer operating time (120 vs 60 min; p\0.001)
and a significantly longer hospital stay (6 vs 4 days;
p=0.003). Nevertheless, the global morbidity rate and the
type of complications according to Dindo’s classification
were similar. In the multivariate analysis, the only inde-
pendent predictor of PP was tumor distance from the anal
verge (p=0.010). During a median follow-up period of
48 months (range, 12–150 months), no liver or peritoneal
metastases were detected in 13 patients with rectal cancer.
Conclusions Peritoneal perforation does not seem to
affect short-term or oncologic outcomes for patients sub-
mitted to TEM with full-thickness resection for upper
rectum neoplasms. The use of TEM to resect rectal lesions
involving the intraperitoneal rectum may therefore repre-
sent an intermediate step toward the development of
transrectal natural orifice translumenal endoscopic surgery
(NOTES) techniques.
Keywords Full-thickness excision Morbidity
Peritoneal perforation Rectal neoplasm Transanal
endoscopic microsurgery
Routine excision of the intact mesorectum for cancer of the
mid and low rectum has resulted in the lowest incidence of
local recurrences ever reported [1]. Nevertheless, total
mesorectal excision (TME) is associated with high rates of
genitourinary dysfunctions [25], anastomotic leakage [6],
and long-term functional bowel discomfort [7].
Proposed by Buess et al. [8,9] nearly 30 years ago,
transanal endoscopic microsurgery (TEM) combines the
advantages of minimally invasive local treatment with
large full-thickness local resection and improved visuali-
zation. It rapidly became the standard of treatment for large
rectal adenomas [10,11].
More recently, TEM has become a viable alternative in
the management of selected early rectal cancer [12,13].
Combined with neoadjuvant treatment, TEM is progres-
sively extending its indications because of its mild impact
on patient recovery [14].
Originally, TEM was devised to remove extraperitoneal
lesions. A peritoneal perforation (PP) was frequently
M. Morino M. E. Allaix (&)F. Famiglietti
M. Caldart A. Arezzo
Digestive, Colorectal, Oncologic and Minimally Invasive
Surgery, Dipartimento di Discipline Medico-Chirurgiche,
University of Torino, Corso A. M. Dogliotti 14, 10126 Torino,
Italy
e-mail: Marcoettore_allaix@yahoo.it
M. Morino
e-mail: mario.morino@unito.it
123
Surg Endosc (2013) 27:181–188
DOI 10.1007/s00464-012-2418-x
and Other Interventional Techniques
reported as a complication of TEM, and tumors of the
upper rectum, particularly when located on the anterior or
lateral portion of the rectum, were considered a contrain-
dication to TEM [1518]. Peritoneal perforation makes it
difficult or impossible to maintain a stable pneumorectum,
often creating a formidable technical challenge for the
surgeon. Furthermore, insufflation of carbon dioxide (CO
2
)
from the rectum into the peritoneum is considered a
potential cause of clinical and oncologic complications.
Nevertheless, these concerns have only rarely been
addressed in the literature, with no mention of the long-
term oncologic consequences of PP.
However, the recent introduction of natural orifice
translumenal endoscopic surgery (NOTES) techniques as
means of access to the peritoneum through the rectum has
aroused controversy about the safety and efficacy of such a
proposal [19]. We believe that with an analysis of the
clinical consequences resulting from PP during TEM, some
points in the debate could be clarified and that the current
technical and clinical limitations of local excision of rectal
neoplasms by TEM could be elucidated.
Thus, this study aimed to evaluate the influence of PP on
the short- and long-term outcomes for patients undergoing
TEM and to compare our results with evidence from the
literature.
Material and methods
This study was a retrospective analysis of a prospective
database created in January 1993. Patients in whom a PP
occurred during a TEM procedure were identified from the
data on the operative report. The indications for TEM were
benign rectal lesions judged unsuitable for endoscopic
removal, early rectal cancer, and invasive or metastatic
rectal carcinoma treated with palliative intent.
A rigid rectoscopy was routinely performed to locate the
lesion along the circumference and to measure its distance
from the anal verge. The preoperative workup and surgical
technique have been described previously [20].
The procedure was performed with the patient under
general anesthesia in all cases. Until 2008, we routinely
used Richard Wolf (Knittingen, Germany) TEM equipment
conceived by Buess [8]. Afterward, we used transanal
endoscopic operation (TEO) instrumentation (Karl Storz
GmbH, Tuttlingen, Germany).
When the original Richard Wolf TEM equipment was
used, patient positioning was varied to keep the lesion in
the inferior part of the surgical field. Since we began to use
the TEO instrumentarium, the patient ordinarily is placed
supine due to the particular shape of the TEO rectoscope
tip, which allows tissue handling over the entire surgical
field, including its superior quadrant. Nevertheless, for
treating lesions in the upper rectum and large neoplasms
involving the anterior rectal wall, which are at risk for PP,
the patient is placed prone to reduce gas losses and to help
to maintain a stable pneumorectum if a PP occurs.
Since 2008, when we began to use the TEO, and with
increasing surgical experience, a more liberal policy
toward lesions located higher has been adopted. In all cases
in this series, a full-thickness excision was made on the
rectal wall to the perirectal fatty tissue, and the wound was
closed with one or more running sutures secured with
dedicated silver clips (Richard Wolf). The same technique
was used to close the peritoneum and to reconstruct the
rectum if PP occurred.
We analyzed patient characteristics, operative data, and
the short- and long-term outcomes of two groups: the no
peritoneal perforation (NPP) group and the PP group. The
patient characteristics were age, gender, and preoperative
indication for TEM. The operative data included length of
the operative procedure and rate of conversion to abdom-
inal surgery. The short-term outcomes were defined as
postoperative morbidity according to Dindo’s classification
[21], 30-day mortality, and length of hospital stay. The
long-term outcomes were defined as the local tumor
recurrence rate and the incidence of distant metastases.
Follow-up assessment involved digital examination,
rectoscopy, and tumor marker testing (in case of malignant
lesions) every 3 months for the first 2 years, then every
6 months thereafter. A full colonoscopy was performed at
12, 36, and 60 months. In case of malignancy in NPP group
and in all cases of PP, abdominal and pelvic computed
tomography (CT) scans also were obtained at 6, 12, and
24 months for early detection of peritoneal seeding (of
adenomatous or cancer tissue) and liver metastases.
Quantitative data are given as median and range.
Chi-square tests were used to compare proportions. The
Student’s t-test was used to compare normally distributed
variables.
A stepwise logistic regression analysis was performed to
identify factors predictive of PP. The variables potentially
related to PP with a pvalue of 0.200 or less in the univariate
analysis were entered into a multivariate analysis. The pre-
dictor variables used were patient age, gender, tumor diam-
eter, tumor distance from the anal verge, and tumor
localization on the rectal wall. A level of 5 % was set as the
criterion for statistical significance. The data were entered on
an Excel spreadsheet. The statistical analysis was performed
using SPSS Software (SPSS Inc., Chicago, IL, USA).
Results
Between January 1993 and December 2010, 481 patients
(289 males and 192 females; median age, 68 years; range,
182 Surg Endosc (2013) 27:181–188
123
13–94 years) underwent TEM. Perforation of the perito-
neum occurred in 28 cases (5.8 %, PP group), with 14
cases (50 %) involving men (median age, 70.5 years;
range, 41–94 years). Peritoneal perforation was experi-
enced by 15 (8.5 %) of 177 patients who had surgery in the
preceding 4 years versus 13 of 304 patients (4.3 %) who
underwent surgery earlier (p=0.090). Table 1reports the
patients’ characteristics and perioperative data.
The preoperative indications were 23 adenomas and 5
carcinomas (4 uT1N0 and 1 uT2N0). The median diameter
of the rectal lesion was 5 cm (range, 3–10 cm). The dis-
tance between the lower edge of the neoplasm and the anal
verge ranged between 6 and 13 cm (median, 9 cm).
In the PP group, the neoplasm was located on the anterior
wall in ten patients (35.7 %), the lateral wall in nine patients
(32.1 %), and the posterior wall in four patients (14.3 %). It
was circumferential in five patients (17.9 %).
In 25 cases (89.3 %), the PP was sutured by TEM. In 3
cases (10.7 %), PP necessitated conversion to laparoscopic
(2 cases) or open (1 case) anterior resection. All conver-
sions occurred during the first 100 TEM procedures (3/100
vs 0/381; p=0.007). The median operating time was
120 min (range, 35–320 min). Excluding the 3 cases con-
verted to abdominal surgery, the operating time ranged
from 35 to 240 min (median, 120 min). No intraoperative
blood transfusions were required.
We observed one case of postoperative complications
(3.6 %) involving a rectovesical fistula that required sub-
sequent abdominoperineal resection. No 30-day mortality
was observed. The median hospital stay was 6 days (range,
4–14 days).
Compared with the NPP group, the PP patients showed a
significantly longer operating time (120 vs 60 min;
p\0.001) and a significantly longer hospital stay (6 vs
4 days; p=0.003). Nevertheless, the global morbidity rate
and type of complications were similar in the two groups
(Tables 1,2). Histologic examination of the surgical
specimens confirmed an adenoma in 15 cases (53.6 %),
with invaded margins in 3 cases (20 %). The rate of margin
invasion was higher than that of the 246 patients with
adenoma in the NPP group, but the difference was not
significant (20 vs 10.2 %; p=0.444). A rectal cancer was
diagnosed in the remaining 13 patients (46.4 %): 7 pT1, 5
pT2, and 1 pT3. Histology detected no margin invasion in
this group. In two cases, the margin clearance was less than
1 mm. The resection was judged to be full thickness in all
cases, and no specimen fragmentation occurred.
Table 3shows the univariate analysis for risk of PP. Of
all the variables taken into consideration, tumor distance
from the anal verge (p=0.005), tumor diameter
(p=0.038), and tumor location on the entire circumfer-
ence (p\0.001) demonstrated a statistically significant
role. The multivariate analysis of the risk for PP, also
shown in Table 3, indicates tumor distance from the anal
verge as a unique independent predictor (p=0.010).
During a median follow-up period of 72 months (range,
12–216 months), no patient with adenoma was lost to
follow-up evaluation. At this writing, all patients are dis-
ease free with no sign of local recurrence or intraperitoneal
seeding of adenomatous tissue.
Table 1 Patient characteristics
PP (n=28) NPP (n=453) pvalue
Male gender: n(%) 14 (50) 275 (60.7) 0.356
Median age: years (range) 70.5 (41–94) 67 (13–91) 0.366
Median distance from anal verge: cm (range) 9 (6–13) 7 (2–15) \0.001
Median tumor diameter: cm (range) 5 (3–10) 4 (3–12) 0.372
Median operative time: min (range) 120 (35–320)
120 (35–240)
a
60 (15–235) \0.001
\0.001
Postoperative complications: n(%) 1 (3.6) 28 (6.2) 0.879
Median hospital stay: days (range) 6 (4–14) 4 (2–20) 0.003
PP peritoneal perforation group, NPP no peritoneal perforation group
a
Three cases of conversion to abdominal surgery were excluded
Table 2 Postoperative morbidity according to Dindo’s classification
PP
(n=28)
NPP
(n=453)
pvalue
n(%) n(%)
Postoperative
complications
1 (3.6) 28 (6.2) 0.879
Grade 1 0 6 (1.3) 0.781
Grade 2 0 9 (1.9) 0.999
Grade 3 1 (3.6) 13 (2.9) 0.716
3a 0 6 (1.3) 0.781
3b 1 (3.6) 7 (1.5) 0.934
Grade 4 0 0
Grade 5 0 0
PP peritoneal perforation group, NPP no peritoneal perforation group
Surg Endosc (2013) 27:181–188 183
123
During a median follow-up period of 48 months (range,
12–150 months), no patient with rectal cancer was lost to
follow-up evaluation. The follow-up period was longer than
3 years for 69% (9/13) of the patients, and longer than 4 years
for 46.1 % (6/13) of the patients. At this writing, all the
patients with a pT1 rectal cancer are disease free. Among the
pT2 patients, two patients underwent postoperative chemo-
radiotherapy, two patients had abdominal surgery (laparo-
scopic TME), and all are disease free at this writing. Neither
patient submitted to TME had any intraoperative evidence of
liver metastases or peritoneal carcinomatosis. Their postop-
erative course was uneventful. One pT2 patient refused any
treatment after TEM, had a local recurrence after 13 months,
underwent chemoradiotherapy, and died of lung metastases
42 months after TEM. The uT2 patient who underwent TEM
with palliative intent because of severe cardiac comorbidities
and had a postoperative diagnosis of pT3 rectal cancer locally
relapsed after 4 months, refused further treatment, and died of
lung metastases 12 months after TEM. During the follow-up
period, no liver or peritoneal metastases were detected in any
of the patients who had neoplasms treated with radical intent
in the PP group (Table 4).
Discussion
Although PP is frequently considered a complication of
TEM [18,2234], few studies have addressed this concern
specifically to date [3537]. With a view to clarify the
short- and long-term implications of PP during TEM, we
analyzed our series of 28 PP cases and compared the results
with the published data.
Globally, 17 studies [18,2237] have reported the
number of PP occurrences during TEM, showing a mean
PP rate of 4.8 % (148/3100) (Table 5). The reported rate of
PP varies widely between 0 and 32.3 %, reflecting the fact
that a submucosal dissection may be preferred over a full-
thickness excision in cases at risk for PP. However, due to
the discrepancy existing between pre- and postoperative
histology and staging, our policy is to offer an appropriate
Table 3 Risk factors for peritoneal perforation
Variable n=481 Univariate analysis Multivariate analysis
OR (95% CI) pvalue
a
OR (95% CI) Pvalue
a
Age (years)
\68 240 1 0.538
C68 241 1.371 (0.637–2.944)
Gender
Female 192 1 0.356
Male 289 1.544 (0.717–3.305)
Tumor diameter (cm)
\4 271 1 0.038 1 0.235
C4 210 2.446 (1.106–5.423) 1.835 (0.801–3.276)
Distance from the anal verge (cm)
\7 198 1 0.005 1 0.010
C7 283 4.494 (1.532–13.151) 4.276 (1.488–12.266)
Rectal wall
Posterior 181 1 1
Lateral 119 2.766 (0.792–9.663) 0.180 1.833 (0.668–8.011) 0.254
Anterior 169 3.382 (0.987–10.699) 0.053 2.108 (0.880–9.049) 0.105
Circumferential 12 31.607 (14.131–70.668) \0.001 20.014 (0.910–55.467) 0.082
OR odds ratio, CI confidence interval
a
Stepwise logistic regression analysis
Table 4 Oncologic results in patients with peritoneal perforation
(PP)
Adenoma
(n=15)
Carcinoma (n=13)
pT1
(n=7)
pT2–3
(n=6)
Median follow-up: months
(range)
72 (12–216) 48 (12–150)
Local recurrence: n(%) 0 0 2 (33)
Peritoneal seeding: n(%) 0 0 0
Liver/peritoneal
metastases: n(%)
NA 0 0
Lung metastases: n(%) NA 0 2 (33)
NA not applicable
184 Surg Endosc (2013) 27:181–188
123
full-thickness excision, even in the case of anterior wall
lesions, to obtain a complete specimen and to allow a
correct pT staging.
To date, no study has assessed the risk factors for PP. In
our series, in the multivariate analysis, a tumor distance of
7 cm or more from the anal verge was the unique inde-
pendent predictor of PP, whereas the tumor location on the
anterior rectal wall or on the entire circumference showed a
statistical trend toward an increased risk for PP (p=0.105
and p=0.082, respectively).
We observed a trend toward a higher rate of PP in our
series over the last 4 years compared with the preceding
period (8.5 vs 4.3 %, p=0.090), reflecting the extension
of indications to larger and more proximal lesions. The
extension of indications for TEM in our series derived not
only from increased surgical experience and dexterity but
also from the use of the TEO instrument (Karl Storz
GmbH), which allows manipulation and suturing of the
rectal wall on a 360°surface, thanks to the particular shape
of the rectoscope tip.
Concerning intraoperative outcomes, we found that PP
was associated with a significantly longer operative time,
mainly related to the proximal location of the lesion and
closure of the defect, which are technically challenging,
rather than to the learning curve of the surgeon. The
learning curve and the case volume of the surgical centre
Table 5 Peritoneal perforation during transanal endoscopic microsurgery (TEM): review of the literature
Author (year) No. of
TEMs
No. of
PPs (%)
No. of
conversions
(%)
No. of
stomas (%)
Postoperative
morbidity (%)
Median
postoperative stay
(days)
Local
recurrence
(%)
Distant
metastasis
(%)
Demartines
et al [18]
50 2 (4) 1 (50) 1 (50) NA NA NA NA
Cocilovo et al
[22]
56 1 (1.8) 1 (100) 0 NA NA NA NA
Dafnis et al
[23]
58 1 (1.7) 1 (100) 0 NA NA NA NA
Meng et al
[24]
31 2 (6.5) 0 0 0 NA NA NA
Palma et al
[25]
100 8 (8) 1 (12.5) 0 0 NA NA NA
Platell et al
(2004) [26]
113 3 (2.7) 0 0 0 NA NA NA
Whitehouse
et al [27]
146 20 (13.6) 0 6 (30) 0 4.5 NA NA
Ganai et al
(2006) [28]
144 9 (6) 0 0 NA NA NA NA
Zacharakis
et al [29]
76 3 (3.9) 2 (66.6) 1 (33.3) NA NA NA NA
Serra-Aracil
et al [30]
96 1 (1) 0 0 0 NA NA NA
Ramirez et al
[31]
173 7 (4) 1 (14.3) 0 NA NA NA NA
de Graaf et al
[32]
353 28 (8.7) 0 0 0 NA NA NA
Guerrieri et al
[33]
402 13 (3.2) 0 0 NA NA NA NA
Le
´onard et al
[34]
123 2 (1.6) 1 (0.8) 0 0 NA NA NA
Gavagan et al
[35]
34 11 (32.3) 0 0 45 NA NA NA
Ramwell et al
[36]
257 15 (5.8) 5 (33.3) 6 (40) 27 8 NA NA
Baatrup et al
[37]
888 22 (2.5) 0 0 4.5 7 10 14
Global 3100 148 (4.8) 13 (8.8) 14 (9.4)
Current series 481 28 (5.8) 3 (10.7) 1 (3.6) 3.6 6 7 0
PP peritoneal perforation, NA not available
Surg Endosc (2013) 27:181–188 185
123
are two main factors that can influence the treatment
strategy to be adopted when PP occurs. It is noteworthy
that conversion to laparotomy was reported in 50–100 % of
PP cases only in a series with fewer than 100 patients,
whereas it ranged between 0 and 40 % in larger series
(Table 5).
These data confirm the results obtained by Salm et al.
[38] in a survey of 1,900 TEM procedures performed in
Germany in 1994. They reported that the rate of conversion
to laparotomy during TEM for all causes, including inad-
vertent transrectal opening of the peritoneal cavity,
decreased with experience from 11.6 % (1 to 10 TEM
procedures) to 1.2 % ([100 TEM procedures). In our ser-
ies, three conversions were performed during the first 100
TEMs compared with 0/381 in more recent years
(p=0.007), confirming the crucial role that experience
plays in the management of PP.
Only a few studies [2427,30,32,3437] have reported
a specific postoperative morbidity rate (range, 0–27 %). No
cases of pelvic sepsis or infectious complications after PP
have been reported. In our series, we observed no statisti-
cally significant difference in the overall complication rate
(3.6 vs 6.2 %) or the degree of severity according to
Dindo’s classification between the PP and NPP groups
(3.6 % of grade 3b complications in the PP group vs 1.5 %
in the NPP group). A longer hospital stay (6 vs 4 days) was
observed for the PP patients, mainly due to a more con-
servative postoperative management.
This study had some limitations, including the retro-
spective design and the relatively small sample size of the
PP group.
However, according to the results of our series, TEM
seems not to be associated with a higher risk for pelvic
infections or other complications when a PP occurs. Fur-
thermore, the low morbidity rate and the absence of pelvic
infectious complications in our series demonstrate that a
nonfunctioning stoma generally is not necessary in high-
volume institutions (Table 5).
To our knowledge, the only study to evaluate the on-
cologic results of patients undergoing TEM with an inad-
vertent PP was that by Baatrup et al. [37], who reported 22
perforations into the peritoneal cavity during a total of 888
TEM procedures for rectal cancer performed at four
European centers. During a median follow-up period of
36 months (range, 3–164 months), local recurrence devel-
oped in one pT1 patient (7 %) and in one pT2 patient
(25 %), whereas distant metastases were detected in three
patients.
In our series, at this writing, during a median follow-up
period longer than 4 years, all the patients who experienced
a PP during TEM for adenoma or pT1 rectal cancer are
disease free, with no sign of intraperitoneal seeding of
adenomatous or cancer tissue. Four pT2 patients who
underwent laparoscopic TME or chemoradiotherapy and
remain disease free. Local recurrence developed only in the
pT2 and pT3 patients who did not receive further treatment
after TEM. No patient with PP has experienced liver or
peritoneal metastases. Therefore, although a limited num-
ber of patients were evaluated and in a retrospective way,
PP does not seem to correlate with an increased risk of
local recurrence or liver/peritoneal metastasis.
In the NOTES era, transrectal access to the peritoneal
cavity has been variously described [3942], taking into
consideration feasibility and risk for fecal contamination of
the abdomen. In an experimental trial, Denk et al. [43]
demonstrated the feasibility of some transrectal NOTES
procedures (diagnostic peritoneoscopy, liver biopsy, sig-
moid resection) using TEM instrumentation, suggesting
TEM as a portal for NOTES.
The experience gained in handling PP with TEM and the
good results of the current series could enhance confidence
in the management of such situations. The use of TEM to
resect rectal lesions involving the intraperitoneal rectum
may therefore represent an intermediate step toward the
development of transrectal NOTES techniques [19].
However, we believe that the application of the transanal
approach to NOTES may be limited in the future to
selected centers with tremendous experience in TEM to
minimize the risks of conversion to abdominal surgery,
stoma, and perioperative complications. From analysis of
the published data, we found that a stoma was more fre-
quently performed (30–50 %) in series with fewer than 100
TEM procedures [18,29] or by surgeons not particularly
skilled in endoscopic closure of the peritoneal defect [36]
(Table 5).
In our series, no stoma was performed intraoperatively
for PP. Only one patient (3.6 %) had a stoma for treatment
of a postoperative rectovesical fistula after a TEM proce-
dure for a lesion on the anterior rectal wall.
In conclusion, evidence from the literature and our per-
sonal experience suggest that when TEM is performed at
expert centers, indications for TEM can be safely extended
to selected lesions in the upper rectum with no further risk
of conversion to abdominal surgery or a nonfunctioning
stoma and with good early and late oncologic results.
Disclosures The authors Mario Morino, Marco Ettore Allaix,
Federico Famiglietti, Mario Caldart, and Alberto Arezzo have no
conflicts of interest or financial ties to disclose.
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... Proposed risk factors for accidental peritoneal opening include full-thickness TEM excision of lesions located in the upper rectum and in the anterior and lateral rectal wall [46][47][48]. These papers also demonstrated that for a surgeon with appropriate skills in transanal surgery, peritoneal entry during TEM can be safely closed transanally with direct defect sutures without the need for abdominal exploration [45,46] and was not followed by increased postoperative morbidity [45,48,49]. As previously demonstrated in large TEM series, [47,48], the occurrence of peritoneal entry was not associated with increased risks of infectious or other postoperative complications, or longer hospital stay. ...
... As previously demonstrated in large TEM series, [47,48], the occurrence of peritoneal entry was not associated with increased risks of infectious or other postoperative complications, or longer hospital stay. Several series have also demonstrated that peritoneal entry during TEM resection of rectal cancer was not associated with worse oncologic outcomes [48,49]. Peritoneal entry during TAMIS has not been as frequently reported as during TEM procedures. ...
... Also female sex during excision of anteriorly located lesions has been advocated as a risk factor due to the lower reflection of the anterior peritoneum in the female pelvis. Some authors state that in experienced hands, the majority of peritoneal defects could be closed transanally with significant decrease in conversion rate [49]. It is important to note that the definition used for peritoneal entry across different series is really heterogeneous, including: "major leakage of CO2 into the abdominal cavity resulted in significant technical difficulties" [55], "visible entrance into the peritoneal cavity" [46], "direct visualization of the defect during surgery" [45], while many studies do not explicitly state how they defined peritoneal entry [47,48]. ...
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Transanal endoscopic microsurgery (TEM) is a minimally invasive technique introduced in the 1980s to overcome the technical difficulties in the management of low rectal tumors. The TEM system includes a dedicated rigid rectoscope and platform with a dedicated expensive instrumentation. The transanal minimally invasive surgery (TAMIS) technique was introduced to overcome these limitations. Transanal surgery consists of three main steps: exposure of the lesion, tumor excision, and defect closure. Traditional indications are benign adenomas and selected T1 rectal cancers. However, when combined with neoadjuvant chemoradiotherapy (n-CRT), the indications may be extended to patients with selected T2-T3 rectal cancers responsive to n-CRT. Intraoperative complications may be difficult to deal with, but peritoneal entry is adequately managed by endoluminal direct closure of the defect by expert surgeons. Concerning the indications for defect closure, there is no evidence of better results to prevent complications such as bleeding; the indication for defect closure should be evaluated according to multiple variables. The management of other complications is safe and does not affect TEM’s oncological and functional outcomes. Transanal excision of rectal tumor is a safe and effective alternative to conventional resection to avoid the low anterior resection syndrome, with comparable oncological results and with the advantages of an organ-sparing strategy for better patients’ QoL.
... Although mucosectomy has been described as an alternative, currently full-thickness resection is the standard for TEM in most clinics [6]. Nevertheless, full-thickness resection remains an overtreatment for benign lesions and at the same time results in an increased risk of perirectal adverse events, such as urethral injuries and rectovaginal fistulas, as well as perforations, especially in the upper rectum [7][8][9]. ...
... On the other hand, peritoneal entry during TEM is a controversial issue among specialists. Some do not consider it to be an adverse event, since a fullthickness resection in the upper rectum will almost certainly result in peritoneal entry, which can be usually sutured endoscopically and only requires conversion to transabdominal surgery in 10% of perforations [8,38]. Still, as it is associated with prolonged procedure time and increased risk of dehiscence of the suture line, some specialists suggest routine diagnostic laparoscopy with suture line testing for all the patients with peritoneal entry [39][40][41]. ...
Article
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Purpose Transanal endoscopic microsurgery (TEM) and endoscopic submucosal dissection (ESD) are currently the two most popular methods for resecting large rectal adenomas en bloc. However, damage to the mesorectum in the case of TEM, plus the technical challenges and long procedure times of flexible ESD, are major disadvantages of these procedures. Transanal endoscopic microsurgical submucosal dissection (TEM-ESD) is a new technique, combining the ergonomic features of TEM with the minimally invasive approach of ESD. The aim of our study was to assess the feasibility and safety of TEM-ESD for resection of large rectal adenomas. Methods We retrospectively analyzed all TEM-ESD procedures performed in Karlsruhe Municipal Hospital between 2012 and 2019, isolated all cases of adenomas, and analyzed the perioperative and follow-up data of the patients. Results We identified 145 cases matching our criteria. The median size of the lesions was 4.2 cm, and the median operating time was 45 min. The en bloc resection rate was 100%, and the complete en bloc resection rate was 78.6%. The overall morbidity rate was 6.9%. In a median follow-up period of 24 months, there was a local recurrence in 4.8% of the cases. Conclusions TEM-ESD is a safe and feasible therapeutic option for resecting large rectal adenomas, offering high en bloc resection and low recurrence rates combined with short operating time and low morbidity. Trial Registration Number (ClinicalTrials.gov) NCT04870931.
... Despite performing full-thickness resections of the wall, in the present series there were no cases of perforation within the abdominal cavity, which, in other series, were observed in up to 6% of the cases. 44,45 This is due to the fact that we selected patients with lesions of either the middle or lower rectum, reducing the possibility of this complication. Although mortality rates are low, they are reported in up to 2% of the cases. ...
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Background In transanal minimally-invasive surgery (TAMIS), the closure of the rectal defect is controversial, and endoluminal suture is one of the most challenging aspects. The goal of the present study is to evaluate the short- and medium-term complications of a consecutive series of patients with extraperitoneal rectal injuries who underwent TAMIS without closure of the rectal defect. Materials and Methods A prospective, longitudinal, descriptive study conducted between August 2013 and July 2019 in which all patients with extraperitoneal rectal lesions, who were operated on using the TAMIS technique, were consecutively included. The lesions were: benign lesions ≥ 3 cm; neuroendocrine tumors ≤ 2 cm; adenocarcinomas in stage T1N0; and adenocarcinomas in stage T2N0, with high surgical risk, or with the patients reluctant to undergo radical surgery, and others with doubts about complete remission after the neoadjuvant therapy. Bleeding, infectious complications, rectal stenosis, perforations, and death were evaluated. Results A total of 35 patients were treated using TAMIS without closure of the defect. The average size of the lesions was of 3.68 ± 2.1 cm (95% confidence interval [95%CI]: 0.7 cm to 9 cm), their average distance from the anal margin was of 5.7 ± 1.48 cm, and the average operative time was of 39.2 ± 20.5 minutes, with a minimum postoperative follow-up of 1 year. As for the pathologies, they were: 15 adenomas; 3 carcinoid tumors; and 17 adenocarcinomas. In all cases, the rectal defect was left open. The overall morbidity was of 14.2%. Two patients (grade II in the Clavien-Dindo classification) were readmitted for pain treatment, and three patients (grade III in the Clavien-Dindo classification) were assisted due to postoperative bleeding, one of whom required reoperation. Conclusion The TAMIS technique without closure of the rectal defect yields good results, and present a high feasibility and low complication rate.
... The author also emphasizes the importance of rectal wall suturing skill because damage of peritoneum during the TLE requires such closure. This situation is quite common in anteriorly located tumours and occurs in about 6% of patients [16]. According to Lee et al., closing the defect is beneficial, because postoperative bleeding was less common when the lesion was sutured. ...
Article
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Purpose Our goal was to assess the outcomes of rectal wall suture during the early and late periods after transanal endoscopic microsurgery (TEM) and long-term bowel function. Methods Patients who underwent TEM for rectal neoplasms from May 2017 to March 2021 were prospectively included. A total of 70 patients were enrolled. Seven to 10 days after TEM, clinical data were recorded, and digital rectal examination and rigid proctoscopy were performed. After at least 6 months, bowel function was evaluated using low anterior resection syndrome (LARS) and Wexner questionnaires. Results Forty-five men with an average age of 67 ± 10.1 (40–85) were included. TEM sutures were recorded as intact in 48/70 (68%) and as dehiscent in 22/70 (32%). It did not have any significant clinical manifestation and was not related with longer postoperative stay or incidence of postoperative complications. Eight of 22 (36.4%) patients with suture dehiscence had per rectal bleeding or febrile temperature without any need for intervention or treatment. The only risk factor for wound dehiscence was a posteriorly located defect. In late postoperative period, there was no difference between groups in LARS or Wexner questionnaire (p value 0.72 and 0.85, respectively). Conclusions Our study suggests that 1/3 of the patients’ rectal wall defect after TEM will undergo dehiscence in early postoperative period and will not transfer to clinically significant manifestation (without a need of hospitalization or prolonging it). In late postoperative period, there is no difference in bowel function.
Article
Transanal endoscopic microsurgery (TEM) allows the local excision of rectal tumors and achieves lower morbidity and mortality rates than total mesorectal excision. TEM can treat lesions up to 18 to 20 cm from the anal verge, obtaining good oncological results in T1 stage cancers and preserving sphincter function. TEM is technically demanding. Large lesions (>5 cm), those with high risk of perforation into the peritoneal cavity, those in the upper rectum or the rectosigmoid junction, and those in the anal canal are specially challenging. Primary suture after peritoneal perforation during TEM is safe and it does not necessarily require the creation of a protective stoma. We recommend closing the wall defect in all cases to avoid the risk of inadvertent perforation. It is important to identify these complex lesions promptly to transfer them to reference centers. This article summarizes complex procedures in TEM.
Article
Since the introduction of transanal endoscopic microsurgery, local excision of “early” rectal lesions has offered the possibility to reduce the invasiveness of treatment for the limited disease. Flexible endoscopy techniques allow today different alternatives consisting of endoscopic mucosal resection or endoscopic submucosal dissection. The first is a straightforward and relatively easy technique, but it prevents a correct pathological staging of the lesion due to fragmentation and the verification of disease-free margins. The second relies on operators' audacity depending on their increasing experience due to the limited progress in technology. What is the preferable technique today is questionable. All the methods have pros and cons. The future certainly will see the use of ideal systems, allowing the possibility of precision surgery for partial- or full-thickness excision, depending on intraoperative findings, and the extension above the rectosigmoid junction. Miniaturized flexible robotic devices may represent the solution for both issues.
Article
Introduction Transanal endoscopic microsurgical submucosal dissection (TEM-ESD) is a technique that has been recently described for the treatment of large rectal adenomas and early rectal cancer. The purpose of our study is to compare TEM-ESD with flexible endoscopic submucosal dissection (ESD) in an experimental, ex vivo porcine model. Material and methods We used TEM-ESD and flexible ESD to resect a total of 100 standardized 4 × 4cm lesions in an ex vivo porcine stomach model, performing 50 resections with each technique. Total procedure time, en bloc resection rate, injuries of the muscularis propria, perforation rate and learning curve were analysed. Results TEM-ESD was associated with a significantly shorter total procedure time in comparison to ESD (19 min vs. 33 min, p < .001). The rates of en bloc resection, injury of the muscularis propria layer, and perforation were the same in both groups. The learning curve of TEM-ESD was shallower than that of ESD. Conclusion TEM-ESD showed an advantage over ESD in terms of procedure time and learning curve, with similar en bloc resection rates and safety profile in our experimental model.
Article
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Background: Management of rectal defect after TEM is a matter of debate. Data are lacking on long term outcomes and continence of patients with open or closed rectal defect. We sought to analyse these in a retrospective cohort study. Methods: Patients undergoing TEM via the Specialist Early Rectal Cancer (SERC) MDT between 2012-2019 were included from a prospectively maintained database. These were divided into two groups - open and closed, based on management of rectal defect. Patient demographics and outcomes, including pre/post-operative oncological staging, morbidity, mortality, length of stay and FISI scores were assessed. Results: 170 matched patients were included (70-open, 100-closed rectal defect). Short-term complications (bleeding, infection, urinary retention and infection, length of stay and pain) were 18.8% with no significant difference between the two groups (22% vs. 16%). Most of the defects were well healed upon endoscopic follow-up; more unhealed/sinus formation was noticed in open group (p=0.01); more strictures were encountered in the closed group (p=0.04). Comparing the open and closed defect groups, there was no difference in the functional outcome of patients in those who developed sinus (p=0.87) or stricture (p=0.79) but a significant difference in post-TEMS FISI scores in those with healed scar, with those in closed rectal defect group with worsening function (p= 0.02). Conclusion: Both the approaches of rectal defect management are associated with pros and cons. Long term complications should be expected and actively followed up for. Patients should be thoroughly counselled about these and possible deterioration in continence post-TEM.
Article
Background: The aim of this study was to quantify the incidence of short-term postoperative complications and functional disorders at 1 year from transanal endoscopic microsurgery (TEM) for rectal neoplasms, to compare patients treated with TEM alone and with TEM after preoperative chemoradiotherapy (CRT) and to analyse factors influencing postoperative morbidity and functional outcomes. Methods: A retrospective study was conducted on all patients treated with TEM for rectal neoplasms at our institution in January 2000-December 2017. Data from a prospectively maintained database were retrospectively analysed. Patients were divided into two groups: adenoma or early rectal cancer (no CRT group) and locally advanced extraperitoneal rectal cancer with major or complete clinical response after preoperative CRT (CRT group). Short-term postoperative mortality and morbidity and the functional results at 1 year were recorded. The two groups were compared, and a statistical analysis of factors influencing postoperative morbidity and functional outcomes was performed. Functional outcome was also evaluated with the low anterior resection syndrome (LARS) score (0-20 no LARS, 21-29 minor LARS and 30-42 major LARS). Results: One hundred and thirteen patients (71 males, 42 females, median age 64 years [range 41-80 years]) were included in the study (46 in the CRT group). The overall postoperative complication rate was 23.0%, lower in the noCRT group (p < 0.001), but only 2.7% were grade ≥ 3. The most frequent complication was suture dehiscence (17.6%), which occurred less frequently in the noCRT group (p < 0.001). At 1 year from TEM, the most frequent symptoms was urgency (11.9%, without significant differences between the CRT group and the noCRT group); the noCRT group experienced a lower rate of soiling than the CRT group (0% vs. 7.7%; p: 0.027). The incidence of LARS was evaluated in 47 patients from May 2012 on and was 21.3% occurring less frequently in the noCRT group (10% vs. 41.2%; p: 0.012). Only 6.4% of the patients evaluated experienced major LARS. In multivariate analysis, preoperative CRT significantly worsened postoperative morbidity and functional outcomes. Conclusions: TEM is a safe procedure associated with only low risk of severe postoperative complications and major LARS. Preoperative CRT seems to increase the rate of postoperative morbidity after TEM and led to worse functional outcomes at 1 year after surgery.
Article
Full-text available
BACKGROUND: Transanal Endoscopic Microsurgery (TEM) is a minimal invasive procedure for the treatment of rectal tumors. Nowadays there has been an increasing medical interest regarding quantitative measurements pertaining quality of life. AIM: To evaluate life quality of patients submitted to TEM at Hospital de Clínicas of the Federal University of Paraná in the Department of Surgery of the Digestive Tract. METHODS: A prospective observational cohort study was done to evaluate the quality of life after TEM. Thirty-four patients answered a questionnaire composed of 14 questions concerning postoperative and labor issues. Questions concerned primarily about: informed consent; pain felt after surgery; patients capacity to walk during the postoperative state; period of return to normal activities; satisfaction regarding the absence of postoperative scars; postoperative incontinence, as well as the recommendation of this surgery to family members or friends. RESULTS: All thirty-four patients claimed to be adequately informed about the procedure. The absence of postoperative pain was observed in 82.5 %, and all demonstrated the capacity to walk in the first postoperative day. In average, returning to normal activities began after the seventh day of surgery. Only five patients (14.70%) experimented transitory fecal incontinence, enduring no longer than a week. Three patients (8.82%) were later readmitted to the hospital: two with residual tumors and the other for tumor recurrence. Two patients (5.88%) complained about temporary modification in his/her sexual life after the surgery, and 97.05% would indicate TEM for his/her family members or friends. The average time period of admission was of three days. CONCLUSION: Patients presented a good evolution, with little postoperative pain, and a low complication index, demonstrating satisfactory and adequate quality of life after TEM.
Chapter
The system for TEM consists of a rectoscope of 40 mm diameter, stereoscopic optics and up to four surgical instruments for simultaneous application. Operation is performed under automatic gas distension. Since 1983 we have operated upon 332 patients, 280 of whom were analyzed in a prospective clinical trial. The complication rate was below 10%, mortality 0.3% and the recurrence rate ot the adenomas 4%. Compared to the conventional surgical procedures, postoperative pain is significantly lower and hospital stay and rehabilitation time are shorter.
Article
Objective To examine the role of total mesorectal excision in the management of rectal cancer. Design A prospective consecutive case series. Setting A district hospital and referral center in Basingstoke, England. Patients Five hundred nineteen surgical patients with adenocarcinoma of the rectum treated for cure or palliation. Interventions Anterior resections (n=465) with low stapled anastomoses (407 total mesorectal excisions), abdominoperineal resections (n=37), Hartmann resections (n=10), local excisions (n=4), and laparotomy only (n=3). Preoperative radiotherapy was used in 49 patients (7 with abdominoperineal resections, 38 with anterior resections, 3 with Hartmann resections, and 1 with laparotomy). Main Outcome Measures Local recurrence and cancer-specific survival. Results Cancer-specific survival of all surgically treated patients was 68% at 5 years and 66% at 10 years. The local recurrence rate was 6% (95% confidence interval, 2%-10%) at 5 years and 8% (95% confidence interval, 2%-14%) at 10 years. In 405 "curative" resections, the local recurrence rate was 3% (95% confidence interval, 0%-5%) at 5 years and 4% (95% confidence interval, 0%-8%) at 10 years. Disease-free survival in this group was 80% at 5 years and 78% at 10 years. An analysis of histopathological risk factors for recurrence indicates only the Dukes stage, extramural vascular invasion, and tumor differentiation as variables in these results. Conclusions Rectal cancer can be cured by surgical therapy alone in 2 of 3 patients undergoing surgical excision in all stages and in 4 of 5 patients having curative resections. In future clinical trials of adjuvant chemotherapy and radiotherapy, strategies should incorporate total mesorectal excision as the surgical procedure of choice.
Article
Objective: Although quality assessment is gaining increasing attention, there is still no consensus on how to define and grade postoperative complications. This shortcoming hampers comparison of outcome data among different centers and therapies and over time. Patients and methods: A classification of complications published by one of the authors in 1992 was critically re-evaluated and modified to increase its accuracy and its acceptability in the surgical community. Modifications mainly focused on the manner of reporting life-threatening and permanently disabling complications. The new grading system still mostly relies on the therapy used to treat the complication. The classification was tested in a cohort of 6336 patients who underwent elective general surgery at our institution. The reproducibility and personal judgment of the classification were evaluated through an international survey with 2 questionnaires sent to 10 surgical centers worldwide. Results: The new ranking system significantly correlated with complexity of surgery (P < 0.0001) as well as with the length of the hospital stay (P < 0.0001). A total of 144 surgeons from 10 different centers around the world and at different levels of training returned the survey. Ninety percent of the case presentations were correctly graded. The classification was considered to be simple (92% of the respondents), reproducible (91%), logical (92%), useful (90%), and comprehensive (89%). The answers of both questionnaires were not dependent on the origin of the reply and the level of training of the surgeons. Conclusions: The new complication classification appears reliable and may represent a compelling tool for quality assessment in surgery in all parts of the world.
Article
In the period from July 1983 to June 1991, 321 operations were performed using the technique of transanal endoscopic microsurgery (TEM). The most proximal tumours resected were in the lower sigmoid up to 25 cm from the anal verge. The complication rate requiring surgical intervention was 6.5% and the recurrence rate after polypectomy was 5%. Of 44 patients with pT1 low-risk tumours, one developed a recurrence as did two of the three patients with pT1 high-risk tumours. Using the technique of TEM, segmental resections with end-to-end anastomosis are possible in the extraperitoneal part of the rectum.
Article
PURPOSE: The aim of this study was to describe a single institution's experience with transanal endoscopic microsurgery in patients with benign and malignant rectal tumors. PATIENTS: Between January 1992 and April 1998, 75 patients with a mean follow up of 38 months, underwent transanal endoscopic microsurgery excision of benign (46) or malignant (29) rectal tumors, located 3 to 18 cm from the dentate line. RESULTS: A total of 3 of 46 (6.5 percent) patients with benign tumors underwent conversion to radical surgery owing to tumor size. During the follow-up period, benign tumor recurrence was observed in four (9 percent) patients, three of whom were managed by repeat transanal endoscopic microsurgery, whereas one required radical surgery. Histologic staging of malignant tumors was T1 (10), T2 (10), and T3 (9). Seven patients with either inadequate resection margins or T3 tumors were complimented with radical surgery. Of the remaining 22 patients, 11 received adjuvant radiation therapy whereas 11 had no further treatment. Four (18 percent) had recurrent disease, which was managed by repeat transanal endoscopic microsurgery in two, radical surgery in one, and laser ablation in one. No cancer-related deaths were observed during the follow-up period. There was one operative mortality in a cardiac-crippled patient. Postoperative complications were mainly of a minor character and included fever, urinary retention, and bleeding; none of which required reintervention. Rectourethral fistula developed in one patient who underwent repeat transanal endoscopic microsurgery excision for a T3 malignancy. Fecal soiling was transient in three patients and persisted in two. CONCLUSION: Transanal endoscopic microsurgery excision is a safe and precise technique that is well tolerated even in high operative risk patients. Transanal endoscopic microsurgery may become a procedure of choice for benign rectal tumors and selected early malignant neoplasms.
Article
BACKGROUND: With a rapidly expanding international registry of cases, Natural Orifice Translumenal Endoscopic Surgery (NOTES) continues to be held as the next phase in minimally invasive surgery. While pure and hybrid transvaginal procedures predominate clinically, there is growing interest in transanal NOTES as it may potentially minimize the morbidity of colorectal resections. METHODS: Extensive experimental and clinical evidence support the fact that septic complications from intentional colotomy during colorectal procedures are minimized with adequate closure. Other advantages of transanal NOTES include the favorable ergonomics of transanal endoscopy and availability of Transanal Endoscopic Microsurgery (TEM) as a particularly well-suited endoscopic platform. RESULTS: Since the description of transanal endoscopic rectosigmoid resection using TEM in 2007, extensive evaluation in swine acute and survival studies has demonstrated that this technique is feasible, safe, and easily reproducible using conventional instrumentation. Validation of this approach in human cadavers has confirmed the feasibility of transanal total mesorectal excision using a standardized technique. In the first clinical report published to date, transanal endoscopic rectosigmoid resection with TME was performed using laparoscopic assistance in a female patient with a stage III mid-rectal cancer treated with neoadjuvant therapy. CONCLUSIONS: Although preliminary, these results highlight the potential impact of this approach in minimizing the morbidity associated with rectal cancer resection, and warrant further investigation with respect to safety and long-term oncologic outcomes. Improvements in the design of currently available endoscopic platforms and instrumentation will be important for widespread clinical application in the future, and if pure NOTES transanal resection remains the ultimate goal. KeywordsNOTES–Transanal–Rectal cancer–TME–TEM