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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
oral antibiotics
BehavioralPatients 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
BehavioralPatients 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
6
Treatment groupsSee each treatment group below.
Trial outcomes
Primary outcomes
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
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)
Secondary outcomes
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.
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.
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