NCT06745505

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 19, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 20, 2024

Completed
Last Updated

December 20, 2024

Status Verified

December 1, 2024

Enrollment Period

1 year

First QC Date

December 17, 2024

Last Update Submit

December 17, 2024

Conditions

Colorectal SurgeryPediatricBowel Preparation

Keywords

effectivenesspre-operative bowel preparationpediatric colorectal surgery

Outcome Measures

Primary Outcomes (1)

  • No difference in surgical outcome after bowel preparation

    1 year

Study Arms (2)

Recieved Bowel Preparation

EXPERIMENTAL
Procedure: Bowel Preparation

Did not receive Bowel Preparation

ACTIVE COMPARATOR
Procedure: Bowel Preparation

Interventions

Bowel PreparationPROCEDURE

Group A received bowel preparation and Group B did not.

Did not receive Bowel PreparationRecieved Bowel Preparation

Eligibility Criteria

Age6 Months - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pediatric Surgery, Holy Family Hospital, Rawalpindi

Rawalpindi, Punjab Province, 87500, Pakistan

Location

MeSH Terms

Interventions

Cathartics

Intervention Hierarchy (Ancestors)

Gastrointestinal AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Muhammad Salman Qamar, MBBS

    Rawalpindi Medical College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Pediatric Surgery

Study Record Dates

First Submitted

December 17, 2024

First Posted

December 20, 2024

Study Start

July 1, 2023

Primary Completion

June 30, 2024

Study Completion

August 19, 2024

Last Updated

December 20, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)