Oral Antibiotics vs. No Antibiotics in Pediatric Colorectal Surgery

NCT07713433 | Recruiting

• 1 other identifier: 952/CH-UCHS
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate whether giving oral antibiotics before elective colorectal surgery can improve recovery and reduce complications in children. Colorectal surgery is commonly performed in children for conditions such as Hirschsprung disease, anorectal malformations, and other bowel disorders. Because the large intestine normally contains many bacteria, these operations carry a higher risk of infection and other postoperative complications. Some surgeons prescribe oral antibiotics before surgery to reduce the number of bacteria in the bowel, while others do not use this approach routinely. In this study, children scheduled for elective colorectal surgery will be randomly assigned to one of two groups. One group will receive oral antibiotics before surgery, while the other group will receive standard preparation without oral antibiotics. All children will otherwise receive the same surgical and postoperative care according to hospital guidelines. Researchers will compare the two groups for important outcomes including surgical site infection, leakage from the bowel connection (anastomotic leak), and length of hospital stay. Additional information regarding recovery and postoperative complications will also be collected. Participation in the study will not affect the quality of treatment provided. Parents or guardians may withdraw their child from the study at any time without affecting routine medical care. The results of this research may help determine whether preoperative oral antibiotics should be routinely used in children undergoing elective colorectal surgery and may contribute to improving surgical outcomes and reducing healthcare costs.

Conditions

Bowel Cleansing Prior to Clinical Procedures; Colorectal Anastomosis

Keywords

pediatric; colorectal; colostomy; duhamel; closure; hirschprung's disease; anorectal malformation; soave pull through; swenson; abdomino-perineal pull through; perineal injury; perineal wounds; ARM; Bowel preparation; oral antibiotics

Outcome Measures

Primary Outcomes (2)

• Incidence of Anastomotic Leak

  It is defined as the disruption of anastomotic site, suspected on clinical examination and confirmed with radiological and operative findings and will be recorded as number of participants with anastomotic leak

  Within three weeks of surgery

• Incidence of Surgical Site Infection

  Surgical site infection will be recorded using Southampton wound grading system and will be presented as number of participants with occurrence of surgical site infection (SSI)

  From day of surgery till 3 weeks post operatively

Secondary Outcomes (2)

• Length of Hospital Stay

  From per-operative day till 30 days post-Operatively

• Grade of Surgical Site Infection

  from 1st day of surgery till 3 weeks post operatively

Study Arms (6)

Oral Antibiotics in ARM

EXPERIMENTAL

Patients of anorectal malformation in this group will receive 3-day mechanical gut preparation along with oral antibiotics including ciprofloxacin and metronidazole one day before surgery

Behavioral: oral antibiotics

No Oral Antibiotics in ARM

ACTIVE COMPARATOR

Patients of anorectal malformation in this group will receive 3-day mechanical gut preparation and no oral antibiotics will be given before surgery

Behavioral: No Oral Antibiotics

Oral Antibiotics in Hirschprung's Disease

EXPERIMENTAL

Patients of Hirschsprung's disease with colostomy in this group will receive 3-day mechanical gut preparation along with oral antibiotics including ciprofloxacin and metronidazole one day before surgery

Behavioral: oral antibiotics

No Oral Antibiotics in Hirschsprung's Disease

ACTIVE COMPARATOR

Patients of Hirschsprung's disease in this group will receive 3-day mechanical gut preparation and no oral antibiotics will be given before surgery

Behavioral: No Oral Antibiotics

Oral Antibiotics in Others

EXPERIMENTAL

Patients with colostomy for conditions other than anorectal malformation or HD, undergoing colostomy closure in this group will receive 3-day mechanical gut preparation along with oral antibiotics including ciprofloxacin and metronidazole one day before surgery

Behavioral: oral antibiotics

No Oral Antibiotics in Others

ACTIVE COMPARATOR

Patients with colostomy for conditions other than anorectal malformation or Hirschsprung's disease in this group will receive 3-day mechanical gut preparation and no oral antibiotics will be administered before surgery

Behavioral: No Oral Antibiotics

Interventions

oral antibiotics BEHAVIORAL

Patients in this group will receive preoperative mechanical bowel preparation for 3 days and oral antibiotics including Metronidazole and Ciprofloxacin one day before surgery

Oral Antibiotics in ARM; Oral Antibiotics in Hirschprung's Disease; Oral Antibiotics in Others

No Oral Antibiotics BEHAVIORAL

Patients in this group will receive only mechanical bowel preparation for 3 days before surgery and no oral antibiotics will be given in these patients before surgery

No Oral Antibiotics in ARM; No Oral Antibiotics in Hirschsprung's Disease; No Oral Antibiotics in Others

Eligibility Criteria

• Age: 1 Year - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children with colostomy planned for colostomy closure or pull through procedure for conditions including
• Anorectal malformation
• Hirschsprung's Disease
• Perianal Infections
• Perineal Trauma
• Any other condition requiring diversion colostomy

You may not qualify if:

• Children with small bowel stomas
• poor general condition (Malnutrition, immunodeficiency)
• Previous attempt at repair of colostomy (Reversal/Pull through)

Sponsors & Collaborators

• Muhammad Zubair Shoukat: lead
• University of Child Health Sciences and Children's Hospital, Lahore: collaborator

Study Sites (1)

University of Child Health Sciences, The Children's Hospital, Lahore

Lahore, Punjab Province, 54300, Pakistan

RECRUITING

MeSH Terms

Conditions

Anorectal Malformations

Interventions

Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Digestive System Abnormalities; Digestive System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Mudassar Naveed, MBBS

  University of Child Health sciences & The Children's Hospital, Lahore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mudassar Naveed, MBBS

CONTACT

+923214977599; mudassarnaveed81@gmail.com

Muhammad Zubair Shoukat, MBBS, FCPS Pediatric Surgery

CONTACT

03126446646; zubairshaukat@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: July 20, 2026
• Study Start: January 6, 2025
• Primary Completion: July 1, 2026
• Study Completion: August 1, 2026
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data requests can be submitted starting 12 months after primary article publication and will remain accessible for up to 36 months.
• Access Criteria: Requests must be sent to the corresponding author \[insert email/contact\]. To gain access, requestors must submit a methodologically sound research proposal and a signed Data Sharing Agreement ensuring patient data confidentiality. Final approval rests with the study steering committee

Locations

PA (1)