An interventional study of oral antibiotics and No Oral Antibiotics in Bowel Cleansing Prior to Clinical Procedures and Colorectal Anastomosis, sponsored by Muhammad Zubair Shoukat. Recruiting at 1 site in Pakistan. Open to participants aged 1 Year to 15 Years. Per ClinicalTrials.gov, last updated 2026-07-20.
Sponsored by Muhammad Zubair Shoukat · Not applicable, Interventional, and Prevention
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.
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:
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.
30 studies on the registry are indexed under Anorectal Malformations; 10 are open to participants now.
This study's planned enrollment of 74 is above the median of 30 across 12 interventional studies indexed under Anorectal Malformations.
Browse Anorectal Malformations studies →Muhammad Zubair Shoukat is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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Children with colostomy planned for colostomy closure or pull through procedure for conditions including
Exclusion Criteria:
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
Behavioral: oral antibiotics
Patients of anorectal malformation in this group will receive 3-day mechanical gut preparation and no oral antibiotics will be given before surgery
Behavioral: No Oral Antibiotics
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
Behavioral: oral antibiotics
Patients of Hirschsprung's disease in this group will receive 3-day mechanical gut preparation and no oral antibiotics will be given before surgery
Behavioral: No Oral Antibiotics
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
Behavioral: oral antibiotics
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
Behavioral: No 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
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
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
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
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
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
Plan to share: Yes — De-identified individual participant data that underlie the results reported in the primary article (including text, tables, and figures) will be made available. The study protocol and statistical analysis plan will also be available. Data will only be shared with qualified academic researchers whose proposed use of the data has been approved by the principal investigators
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Data requests can be submitted starting 12 months after primary article publication and will remain accessible for up to 36 months.
Access criteria: Requests must be sent to the corresponding author [insert email/contact]. To gain access, requestors must submit a methodologically sound research proposal and a signed Data Sharing Agreement ensuring patient data confidentiality. Final approval rests with the study steering committee
No publications or documents are linked to this record.
Started Jan 2025 (actual). Primary completion is estimated for Jul 2026, 18 months after the start.
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Muhammad Zubair Shoukat