Comparison of Outcome of Three Days Bowel Preparation vs No Bowel Preparation in Patients of Colostomy Reversal
Phase: NA
Conditions: Colostomy - Stoma, Bowel Preparation, BOWEL ANASTOMOSIS
Sponsor: University of Child Health Sciences and Children's Hospital, Lahore

 
 
Comparison Of Outcomes Of Three Days Vs No Mechanical 
Bowel  Preparation In Patients Undergoing  Colostomy 
Reversal 
 
 
Date : 22-03-25 
NCT : not available till now 
 
 
 
 
 
 
 
 
 
 
 

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SYNOPSIS  
 
“ COMPARISON OF OUTCOMES OF THREE DAYS VS NO 
MECHANICAL BOWEL  PREPARATION IN PATIENTS 
UNDERGOING  COLOSTOMY REVERSAL”   
 
 
 
 
 
 
 
SUBMITTED BY: 
DR. AZIZ AHMAD CHATHA  
Senior Registrar Pediatric Surgery 
The Children’s Hospital & University of Child Health Sciences, Lahore 
 

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INTRODUCTION: 
 
The term “stoma”/ostomy is derived from the Greek word meaning “mouth” 
or “opening” and characterized by the creation of an artificial opening of intestine 
on the surface of body. The first recorded surgical creation of a stoma was by a 
French surgeon Pillore in 1776. (. Stoma formation can be temporary or permanent 
in form of iIeostomy or Colostomy (Harries and Torkington et al, 2018).  
There are lot of indications of stoma formation in children such as anorectal 
malformation, Hirschsprungs Disease, enteric perforation, abdominal tuberculosis, 
abdominal trauma, bowel gangrene, intussusception, intestinal obstruction, large 
perineal wounds, etc.; all these need stoma reversal.(Jan et al, 2007) 
Stoma reversal is the one of the most frequently performed surgeries. Stoma 
reversal has lots of complications such as surgical site infection, poor  scar cosmesis, 
anastomotic leak, paralytic ileus, small bowel adhesive obstruction, bleeding, 
incisional hernia (Jan et al, 2017) , (Harries and Torkington et al, 2018)  and 
hypertrophied scar/keloid, which leads to less patient satisfaction.(Sureshkumar et 
al, 2018). 
Once the requirement of colostomy is over , reversal of colostomy should be 
done in which two ends of the colon or colon and rectum are reconnected. Purpose 
of mechanical bowel preparation is to clean the fecal matter from the large bowel. 
Cleaning prior to colorectal surgery is recommended in many studies. Mechanical 
bowel preparation before surgery have more benefits due to decrease fecal matter as 
well as count of bacteria, which one is the cause of anastomotic dehiscence in 
unprepared patients Mechanical bowel preparation can remove hard, impacted fecal 
matter which decreases the pressure in the lumen of colon (Khan et al.,2019). 
Conventionally,Colostomy is closed after three days preparation of gut. 
Patient is shifted to non-stool forming diet three days prior to surgery. Broad 

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spectrum antibiotics are started two days prior the surgery. Mechanical gut wash is 
performed prior the surgery. The conventional preparation is difficult to perform in 
children as it requires prolonged preoperative NPO. It also prolongs the hospital stay 
of the patient and overburdens the parents socioeconomically (Zahra et al., 2018).  
Research on the adult population has failed to provide statistically significant 
evidence supporting its effectiveness in reducing perioperative complications . 
Moreover, recent evidence has linked MBP prior to colorectal surgery with a higher 
rate of wound infection . pain, distension, and fatigue, water and electrolyte 
imbalance. Now a days,by studying and reviewing local and international data,it is 
noticed that no bowel preparation is equally effective&safe technique for patients 
undergoing colostomy reversal. 
Studies indicate that the quality of evidence for the use of MBP before pediatric 
colorectal surgery is low. On the basis of the existing evidence, MBP seems not to 
decrease the incidence of anastomotic leakage, intra-abdominal infection, or 
wound infection compared to no MBP and may therefore be safely omitted prior to 
colorectal surgery in children.                                                                                                                                                      
 
 

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Hpothesis: 
There is no difference in the outcomes after colostomy reversal done with three 
days bowel preparation versus no bowel preparation in terms of hospital stay, 
anastomotic leak and surgical site infection. 
Objective: 
To compare outcomes of colostomy reversal with three days bowel preparation 
vs no bowel preparation in terms of anastomotic leakage, surgical site infection 
and hospital stay.  
 
Primary Outcomes: 
• Surgical  site infection  
• Anastomotic leak  
Secondary outcome: 
• Hospital stay 
 
 

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OPERATIONAL DEFINITIONS: 
Colostomy Reversal: It is the process of re-approximation of the exteriorized 
ends of colon for the re-establishment of flow of fecal matter through the 
gastrointestinal tract. 
Surgical site infection: It is defined as infection of colostomy reversal wound 
site. Surgical Site Infection (SSI) is classified as a superficial, deep, and 
organ/space infection occurring in the surgical wound within 30 days after the 
operation. It will be calculated using Southampton scoring system (ANEXURE-
I). 
Anastomotic Leak: It is defined as disruption of the re-approximated ends of 
the colon. Anastomic leak will be judged by checking patients clinically as well 
as other haematological and radiological factors (Rahbari et al., 2010). 
 Hospital Stay: Hospital stay will be defined as the number of days starting from 
the day of admission to the day patient is discharged.  
 
 
MATERIAL & METHODS: 
Study design: Prosepective Randomized Controlled Trial  

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Setting: Department of pediatric surgery  The Children’s Hospital & University 
of Child Health Sciences, Lahore 
Sampling Technique:  purposive non-probability sampling 
Sample Size: Calculated by WHO calculator version 12.2.6. 
Group A: No Mechanical Bowel Preparation will be done according to standard 
protocols (Case Group), n= 30 
Group B: Three days Mechanical Bowel Preparation will be done according to 
standard protocols (Control Group), n= 30 
 
SAMPLE SELECTION:   
 Inclusion criteria: 
• Children with colostomy including both gender between the age of  1 to 15 
years. 
• Children of whom parents/guardians will give informed consent. 
 
Exclusion criteria: 
• Consent withdrawn. 
• Poor general condition. 
• A previous history  of anastomotic leakage. 

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• Lost to follow up 
• Children with colostomy requiring pull through procedure. 
 
 
 
 

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Data collection procedure  
Patients fulfilling selection criteria will be enrolled in the study. The study will 
be conducted at the pediatric surgery department, The Children’s Hospital & 
University of Child Health Sciences, Lahore All patients will be subjected to 
detailed perinatal history evaluation, general physical examination necessary 
laboratory investigations, and imaging study (plain radiography, abdominal 
ultrasonography, and echocardiography where required). Informed consent will 
be obtained from the patient’s attendant before surgical intervention. 
Demographic information like name, age, weight, a contact number will be 
recorded. Patients will be randomly divided into two groups by the lottery 
method. Group A will include cases in which no mechanical bowel preparation 
will be done  while in group B  three days bowel preparation will be done. Equal 
pre and post-operative care will be given to all the patients. All patients will be 
operated on by qualified postgraduate surgeons with minimal 3 years of 
experience.  
 
 
 

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Methods: 
The patients will be admitted into the hospital one day or three days before 
surgery depending upon the study group. All patients will have all important 
preoperative investigations and anaesthesia fitness before the surgery. Each 
patient will receive intravenous perioperative antibiotics of cephalosporin 
50mg/kg and metronidazole 7.5mg/kg/8hourly. The antibiotics will be given after 
induction of anaesthesia After surgery, IV antibiotics will be continued, and then 
on discharge oral antibiotics will be given for another 3 days. 
 
 
Procedure for three days bowel preparation: 
Mechanical cleansing of the bowel with three days of bowel preparation will be 
done by admitting the child 3 days before surgery and shifting the patient to a 
non-stool forming diet. The parent or caregiver will be counselled on the 
procedure. Digital rectal examination &stoma examination of every patient will 
be done. The patients will be restricted to a fibre-rich diet and milk from 72 hours 
before surgery. Then the patient will be shifted on clear liquid from 24 hours 
before surgery. And normal saline enema per stoma and through the rectum with 
Nelton tube will be given by the trained person. This will be done the day  before 

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surgery in the afternoon(2PM),in the nigh(10PM) and in the morning (6AM) with 
the goal of clear discharge through rectum or stoma. The patient will be nil per 
oral, 6 hours before surgery (Serrurier et al., 2012). 
 
STATISTICAL ANALYSIS: 
All data will be entered, processed, and analyzed using SPSS  version 24. 
Quantitative variables like age, gender, and hospital stay will be presented as 
frequency and percentage. Mean and S.D will be calculated for quantitative 
variables like age ( months ), and hospital stay. A Chi-square test will be used to 
compare, qualitative variables like SSI and anastomotic leak in both groups. A   
P-value of  ≤ 0.05 will be considered significant. 
 
 

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