Hirschsprung Disease Clinical Trials

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Comparison of Outcomes of Pre-operative Oral Antibiotics vs no Antibiotics in Elective Colorectal Surgeries in Children

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 15
Healthy Volunteers: f
View:

⁃ 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

Locations
Other Locations
Pakistan
University of Child Health Sciences, The Children's Hospital, Lahore
RECRUITING
Lahore
Contact Information
Primary
Mudassar Naveed, MBBS
mudassarnaveed81@gmail.com
+923214977599
Backup
Muhammad Zubair Shoukat, MBBS, FCPS Pediatric Surgery
zubairshaukat@outlook.com
03126446646
Time Frame
Start Date: 2025-01-06
Estimated Completion Date: 2026-08
Participants
Target number of participants: 74
Treatments
Experimental: Oral Antibiotics in ARM
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
Active_comparator: No Oral Antibiotics in ARM
Patients of anorectal malformation in this group will receive 3-day mechanical gut preparation and no oral antibiotics will be given before surgery
Experimental: Oral Antibiotics in Hirschprung's Disease
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
Active_comparator: No Oral Antibiotics in Hirschsprung's Disease
Patients of Hirschsprung's disease in this group will receive 3-day mechanical gut preparation and no oral antibiotics will be given before surgery
Experimental: Oral Antibiotics in Others
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
Active_comparator: No Oral Antibiotics in Others
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
Related Therapeutic Areas
Sponsors
Collaborators: University of Child Health Sciences and Children's Hospital, Lahore
Leads: Muhammad Zubair Shoukat

This content was sourced from clinicaltrials.gov