EFFECTIVENESS of PRE-OPERATIVE BOWEL PREPARATION VS NO BOWEL PREPARATION on OUTCOMES of PEDIATRIC COLORECTAL SURGERIES

To compare the effectiveness of pre-operative bowel preparation vs no bowel preparation on outcomes of pediatric colorectal surgeries.

Study Overview

• Status: Completed
• Conditions: Colorectal Surgery; Bowel Preparation; Pediatric
• Intervention / Treatment: Procedure: Bowel Preparation

Detailed Description

Objective was to compare the effectiveness of pre-operative bowel preparation vs no bowel preparation on outcomes of pediatric colorectal surgeries. After approval from the ethical committee, 62 patients fulfilling the inclusion criteria were enrolled in this study from outpatient department. All participants were examined physically in person by the primary investigator. After which the patients were divided randomly into two groups A and B, 31 patients in each group. Group A patients were undergone bowel preparation while group B patients were not undergone bowel preparation. All patients were operated by a single consultant pediatric surgeon with more than 10 years of experience. Patients were called for follow up weekly till 6 weeks. Hospital stay was noted at the time of discharge. Wound infection rate was assessed till 30th post-operative day while anastomotic leak was ruled out on clinical and radiologic exam if symptoms were present. All the data of this study were analyzed in SPSS version 26. We concluded that that there is no significant difference in surgical outcomes between the group receiving the bowel preparation versus the group not receiving the bowel preparation in terms of surgical site infection rate, anastomotic leak and length of hospital stay.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Rawalpindi, Punjab, Pakistan, 87500
      • Department of Pediatric Surgery, Holy Family Hospital, Rawalpindi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with congenital condition such as Hirschsprung disease, anorectal malformation requiring pull through with or without covering colostomy.
• Patients with anorectal malformation requiring anorectoplasty with or without covering colostomy.
• Ileostomy/colostomy acquired due to intestinal perforation, intestinal obstruction, and trauma admitted for reversal.
• Age up to 12 years.
• Patients of both genders.

Exclusion Criteria:

• Any associated congenital morbid anomaly having Meningomyelocoele, Muscular dystrophy (were assessed on clinical examination)
• Patients with behavior disorders such as autism (were assessed during psychiatric history and clinical examination)
• Patients with behavioral disorder are difficult to counsel and follow up

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Recieved Bowel Preparation	Procedure: Bowel Preparation; Group A received bowel preparation and Group B did not.
Active Comparator: Did not receive Bowel Preparation	Procedure: Bowel Preparation; Group A received bowel preparation and Group B did not.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
No difference in surgical outcome after bowel preparation	1 year

Collaborators and Investigators

• Sponsor: Shaheed Zulfiqar Ali Bhutto Medical University
• Collaborators: Holy Family Hospital, Pakistan
• Investigators: Principal Investigator: Muhammad Salman Qamar, MBBS, Rawalpindi Medical College

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Actual): June 30, 2024
• Study Completion (Actual): August 19, 2024

Study Registration Dates

• First Submitted: December 17, 2024
• First Submitted That Met QC Criteria: December 17, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: effectiveness; pre-operative bowel preparation; pediatric colorectal surgery
• Other Study ID Numbers: RMU-RRF-SUR002-23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No