Clinical trial NCT06745505: EFFECTIVENESS of PRE-OPERATIVE BOWEL PREPARATION VS NO BOWEL PREPARATION on OUTCOMES of PEDIATRIC COLORECTAL SURGERIES
Official title: EFFECTIVENESS of PRE-OPERATIVE BOWEL PREPARATION VS NO BOWEL PREPARATION on OUTCOMES of PEDIATRIC COLORECTAL SURGERIES
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Surgery
Pediatric
Bowel Preparation
Keywords: effectiveness
pre-operative bowel preparation
pediatric colorectal surgery
Lead sponsor: Shaheed Zulfiqar Ali Bhutto Medical University
Sponsor class: OTHER
Collaborators: name: Holy Family Hospital, Pakistan
First posted: 2024-12-20
Enrollment: 62
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: No difference in surgical outcome after bowel preparation
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Department of Pediatric Surgery, Holy Family Hospital, Rawalpindi
state: Punjab
Study officials:
affiliation: Rawalpindi Medical College
name: Muhammad Salman Qamar, MBBS
role: PRINCIPAL_INVESTIGATOR
References: