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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06745505
Enrollment
62
Registered
2024-12-20
Start date
2023-07-01
Completion date
2024-08-19
Last updated
2024-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bowel Preparation, Colorectal Surgery, Pediatric

Keywords

effectiveness, pre-operative bowel preparation, pediatric colorectal surgery

Brief summary

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

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.

Interventions

PROCEDUREBowel Preparation

Group A received bowel preparation and Group B did not.

Sponsors

Holy Family Hospital, Pakistan
CollaboratorOTHER
Shaheed Zulfiqar Ali Bhutto Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
6 Months to 12 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
No difference in surgical outcome after bowel preparation1 year

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026