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RCT COMPARING LAP VERSUS OPEN APPENDECTOMY

Authors:

Abstract

Background: Acute appendicitis is the most common etiology of acute abdomen, with a lifetime incidence between 7 and 9%. In developing country like Nepal, with limited health resources, the trend of laparoscopic appendicectomy (LA) is emerging. This study was conducted to determine difference in clinical outcome and cost analysis between laparoscopic (LA) and open appendicectomy (OA). Methods: This study was RCT conducted in B.P. Koirala Institute of Health Sciences (BPKIHS), a tertiary care hospital in Eastern Nepal, over a period of twelve months from January 2017 to December 2017. Ethical clearance was obtained from Institutional Review Committee (IRC). The study population were adults with clinical diagnosis of acute appendicitis fulfilling inclusion and exclusion criteria. Results: In this study, 47% patients were male and 53% were female in LA and 58.8% patients were male and 41.2% were female in OA ; the mean age was 24.6 years in LA and 27.7 years in OA ; mean operation time was more in LA than in OA i.e. 70 minutes and 57 minutes respectively ( p value 0.001);mean hospital stay was more for OA (3.6 days) as compared to LA (3.06 days), (p value 0.125) ; infection rate was 1% in LA, 6% in OA; The cost of surgery was higher in case of LA (NRs 15067.04) than in OA (NRs. 12524). Conclusions: OA had statistically significant lower pain in 1st three postoperative period, and a shorter hospital stay, early postoperative recovery but a slightly higher cost per discharge than OA. Keywords: Appendicectomy, Cost, Laparoscopic, Open, Outcome
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


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
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
Funding: None
Conict of interest: None
Ethical approval: Obtained from IRC (Institutional
Review Committee)
INTRODUCTION
Reginald Heber Fitz - coined 'appendicitis', which he correctly called
'inflammation in the connective tissue about the caecum'.1
Most common etiology of acute abdomen, generally requiring urgent surgical
intervention, with a lifetime incidence between 7 and 9%.2
Despite advances in modern radiographic imaging and laboratory
investigations, the diagnosis of appendicitis remains essentially a clinical
diagnosis.3
In developing country like Nepal, with limited health resources, the trend of LA
is emerging. Hence, this study was conducted to determine difference in clinical
outcome and cost analysis between LA and OA.
METHODS
Setting: RCT conducted in the Department of Surgery, B.P.K.I.H.S, a tertiary care hospital
in Eastern Nepal, over a period of one year.
Study population and participants: All adult clinically diagnosed cases of acute
appendicitis fulfilling inclusion and exclusion criteria.
I) Inclusion Criteria:
1. All clinically diagnosed case of acute appendicitis and/or
2. MANTRELS Score >7
II) Exclusion Criteria
1. Appendicular lump, abscess, perforation / generalized peritonitis
2. Pregnancy
3. Age <10 or >50
4. Patients not giving informed consent
Sample Size:
This study considered a complication proportion of LA and OA as 0.029 and 0.132
respectively. (Ref: BMC Surgery journal 2014 volume 14, issue 14 ,Minutolo V et al
(2014)
Now using the difference between two proportion formula for a RCT study as below
Where
n= number of sample
Zα/2=1.96 at 95% confidence interval (C.I)
Zβ=0.842 at 80% power (P)
According to literature review, 95% CI and 80% P has been used for sample size estimation
p=1/2(p1+p2); q=1-p; p1= the complication rate of LA; p2=complication rate of OA; q1=1-
p1; q2=1-p2.
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9
MANTRELS SCORE
SYMPTOM SCORE
Migratory RIF pain 1
Anorexia 1
Nausea & Vomiting 1
SIGNS
Tenderness (RIF) 2
Rebound tenderness 1
Elevated temperature 1
LABORATORY
Leucocytosis 2
Shift to left 1
TOTAL 10
Score: 1 to 4-discharge/watchful waiting; 5 to 6-observation/waiting; 7 to 10-
surgery
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!<I</<15=@
1 H % H3 E%   %   H% H'* :   $  
 #5+&+#K'4!"I</;15<=<
!1  P%  K%  %  +% - %  P      $    #5  = '
#*##6-4!I;/15!
;1 E3$?%4# %-%%43K    # '# '
  #5   $ $& ' &    #  # ( $
Q!I!</<15"2="@<
<1 4 )% ,$ % $ ,%  ,%  .% 3 %  >    ? ( 
 #5(- 6##$.'!<I!;/15
<;=<0
21 + --%  --% +-%  ,-% +  ( - &   # (   #5
$#'E&# =6##((E!;I"/015=0
@1 + 6% N -% - :%  ,% , K% , 64%+ ,6    $    # ' 
 #5#!I!2/<15=!"C

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