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

NCT ID: NCT06745505

Last Updated: 2024-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2024-08-19

Brief Summary

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

Detailed Description

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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.

Conditions

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Colorectal Surgery Pediatric Bowel Preparation

Keywords

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effectiveness pre-operative bowel preparation pediatric colorectal surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Recieved Bowel Preparation

Group Type EXPERIMENTAL

Bowel Preparation

Intervention Type PROCEDURE

Group A received bowel preparation and Group B did not.

Did not receive Bowel Preparation

Group Type ACTIVE_COMPARATOR

Bowel Preparation

Intervention Type PROCEDURE

Group A received bowel preparation and Group B did not.

Interventions

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Bowel Preparation

Group A received bowel preparation and Group B did not.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Holy Family Hospital, Pakistan

OTHER

Sponsor Role collaborator

Shaheed Zulfiqar Ali Bhutto Medical University

OTHER

Sponsor Role lead

Responsible Party

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Mansoor Ahmed

Resident Pediatric Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Muhammad Salman Qamar, MBBS

Role: PRINCIPAL_INVESTIGATOR

Rawalpindi Medical College

Locations

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Department of Pediatric Surgery, Holy Family Hospital, Rawalpindi

Rawalpindi, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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RMU-RRF-SUR002-23

Identifier Type: -

Identifier Source: org_study_id