Oral Antibiotics vs. No Antibiotics in Pediatric Colorectal Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-15
SponsorMuhammad Zubair Shoukat

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Anorectal malformation

Hirschsprung's Disease

Perianal Infections

Perineal Trauma

Disqualifiers

Children with small bowel stomas

poor general condition (Malnutrition, immunodeficiency)

Previous attempt at repair of colostomy (Reversal/Pull through)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

  • 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

Treatment groups

74 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Oral Antibiotics in ARMExperimental treatment 1 intervention
Group B: No Oral Antibiotics in ARMActive comparator 1 intervention
Group C: Oral Antibiotics in Hirschprung's DiseaseExperimental treatment 1 intervention
Group D: No Oral Antibiotics in Hirschsprung's DiseaseActive comparator 1 intervention
Group E: Oral Antibiotics in OthersExperimental treatment 1 intervention
Group F: No Oral Antibiotics in OthersActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Within three weeks of surgery
2

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)

Time frame
From day of surgery till 3 weeks post operatively

Secondary outcomes

1

Length of Hospital Stay

It will be measured as time from surgery till discharge in number of days and will be presented as mean and standard deviation.

Time frame
From per-operative day till 30 days post-Operatively
2

Grade of Surgical Site Infection

It will be recorded according to Southampton Grading Scale for SSI (Surgical site Infection) ranging from minimum grade of 0 to maximum grade of 5 where higher grade means more severe infection.

Time frame
from 1st day of surgery till 3 weeks post operatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Muhammad Zubair Shoukat

Lead sponsor

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

Sponsor institution

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

Collaborator