NCT07713433 Oral Antibiotics vs. No Antibiotics in Pediatric Colorectal Surgery
| NCT ID | NCT07713433 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Muhammad Zubair Shoukat |
| Condition | Bowel Cleansing Prior to Clinical Procedures |
| Study Type | INTERVENTIONAL |
| Enrollment | 74 participants |
| Start Date | 2025-01-06 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 74 participants in total. It began in 2025-01-06 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: Children with colostomy planned for colostomy closure or pull through procedure for conditions including 1. Anorectal malformation 2. Hirschsprung's Disease 3. Perianal Infections 4. Perineal Trauma 5. Any other condition requiring diversion colostomy Exclusion Criteria: 1. Children with small bowel stomas 2. poor general condition (Malnutrition, immunodeficiency) 3. Previous attempt at repair of colostomy (Reversal/Pull through)
Contact & Investigator
Mudassar Naveed, MBBS
PRINCIPAL INVESTIGATOR
University of Child Health sciences & The Children's Hospital, Lahore
Frequently Asked Questions
Who can join the NCT07713433 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 15 Years, studying Bowel Cleansing Prior to Clinical Procedures. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07713433 currently recruiting?
Yes, NCT07713433 is actively recruiting participants. Contact the research team at mudassarnaveed81@gmail.com for enrollment information.
Where is the NCT07713433 trial being conducted?
This trial is being conducted at Lahore, Pakistan.
Who is sponsoring the NCT07713433 clinical trial?
NCT07713433 is sponsored by Muhammad Zubair Shoukat. The principal investigator is Mudassar Naveed, MBBS at University of Child Health sciences & The Children's Hospital, Lahore. The trial plans to enroll 74 participants.