Oral Antibiotics vs. No Antibiotics in Pediatric Colorectal Surgery

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

Interventions

BEHAVIORAL

oral antibiotics

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

BEHAVIORAL

No Oral Antibiotics

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

Sponsors & Collaborators

• University of Child Health Sciences and Children's Hospital, Lahore

  collaborator OTHER

• Muhammad Zubair Shoukat

  lead OTHER

Principal Investigators

• Mudassar Naveed, MBBS · University of Child Health sciences & The Children's Hospital, Lahore

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

1 Year

Max Age

15 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-01-06

Primary Completion

2026-07-31

Completion

2026-08-31

Countries

• Pakistan

Study Locations