Oral Antibiotics vs. No Antibiotics in Pediatric Colorectal Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: oral antibiotics, No Oral Antibiotics.
- Who it may be relevant to
- Registry conditions: Bowel Cleansing Prior to Clinical Procedures, Colorectal Anastomosis. Basic parameters: 1 year — 15 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of Outcomes of Pre-operative Oral Antibiotics vs no Antibiotics in Elective Colorectal Surgeries in Children
Overview
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.
Detailed description
Elective colorectal surgery in children is commonly performed for congenital and acquired conditions including Hirschsprung disease, anorectal malformations, stoma reversal procedures, inflammatory bowel disease, and selected colorectal pathologies. Compared with other abdominal operations, colorectal procedures are associated with a higher incidence of postoperative complications, particularly surgical site infections (SSI) and anastomotic leakage, owing to the high bacterial burden of the colon.
Various bowel preparation strategies have been employed to reduce bacterial contamination before colorectal surgery, including no bowel preparation, mechanical bowel preparation (MBP), oral antibiotic bowel preparation (OAB), and combinations of mechanical bowel preparation with oral antibiotics. Although several adult studies have suggested a reduction in postoperative infectious complications with oral antibiotic regimens, evidence in pediatric colorectal surgery remains limited and inconsistent. Consequently, significant variation exists among surgeons regarding the routine use of preoperative oral antibiotics.
This study aims to compare outcomes of preoperative oral antibiotic administration versus no oral antibiotics in children undergoing elective colorectal surgery. The primary objective is to determine whether preoperative oral antibiotics reduce postoperative complications, particularly surgical site infection and anastomotic leakage, and improve recovery as reflected by hospital stay.
This prospective randomized controlled trial will be conducted in the Department of Pediatric Surgery at the University of Child Health Sciences and The Children's Hospital Lahore. A total of 74 patients meeting the eligibility criteria will be enrolled and randomized in a 1:1 ratio into two groups using a lottery-based randomization method. Thirty-seven participants will be allocated to the intervention group and thirty-seven to the control group.
Participants in the intervention arm will receive a standardized regimen of preoperative oral antibiotics one day before surgery. The protocol utilizes oral ciprofloxacin and metronidazole as bowel decontamination agents. Participants in the control arm will undergo standard preoperative preparation without oral antibiotic administration. All other perioperative and postoperative management will follow departmental standard operating procedures and institutional guidelines.
Patients will be monitored for postoperative outcomes including surgical site infection, anastomotic leakage, and duration of hospital stay. Additional demographic, clinical, and operative variables will be recorded to assess potential confounding factors. Follow-up assessments will be conducted according to institutional postoperative protocols to identify early complications and recovery outcomes.
The primary outcomes of the study are:
* Surgical site infection (SSI). * Anastomotic leakage. * Postoperative hospital stay.
Secondary outcomes include overall postoperative morbidity and recovery parameters following elective colorectal surgery.
Data analysis will be performed using SPSS software. Continuous variables such as age and hospital stay will be summarized using means and standard deviations and compared using Student's t-test. Categorical variables, including diagnosis, surgical site infection, and anastomotic leakage, will be presented as frequencies and percentages and compared using Chi-square testing. Stratified analyses will be performed for relevant demographic and clinical variables. Statistical significance will be defined as a p-value of ≤0.05.
This study is expected to provide locally generated evidence regarding the effectiveness of preoperative oral antibiotic bowel preparation in pediatric colorectal surgery. The findings may help establish evidence-based perioperative protocols, reduce infectious complications, shorten hospitalization, and improve overall surgical outcomes in children undergoing elective colorectal procedures.
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
Primary outcome measures
- Incidence of Anastomotic Leak [Time frame: Within three weeks of surgery]
- Incidence of Surgical Site Infection [Time frame: From day of surgery till 3 weeks post operatively]
Secondary outcome measures (2)
- Length of Hospital Stay [Time frame: From per-operative day till 30 days post-Operatively]
- Grade of Surgical Site Infection [Time frame: from 1st day of surgery till 3 weeks post operatively]
Eligibility criteria
Inclusion criteria
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
Exclusion criteria
- Children with small bowel stomas
- poor general condition (Malnutrition, immunodeficiency)
- Previous attempt at repair of colostomy (Reversal/Pull through)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
Pakistan · 1 center
- University of Child Health Sciences, The Children's Hospital, Lahore — Lahore
Identifiers
NCT: NCT07713433 · 952/CH-UCHS