Bowel Cleansing Prior to Clinical ProceduresPEACONCT07713433
Oral Antibiotics vs. No Antibiotics in Pediatric Colorectal Surgery
A study testing oral antibiotics and No Oral Antibiotics in people with Bowel Cleansing Prior to Clinical Procedures and Colorectal Anastomosis, run by Muhammad Zubair Shoukat at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 15 years
- Conditions the study is for
- Bowel Cleansing Prior to Clinical Procedures, Colorectal Anastomosis
- What is being tested?
- oral antibiotics and No Oral Antibiotics
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 sitePakistan
- Study dates
- 6 Jan 2025to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Children with small bowel stomas
- poor general condition (Malnutrition, immunodeficiency)
- Previous attempt at repair of colostomy (Reversal/Pull through)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
University of Child Health Sciences, The Children's Hospital, Lahore
Lahore, Punjab Province, 54300
Mudassar Naveed, MBBS, +923214977599, mudassarnaveed81@gmail.com
About this study
Official title: Comparison of Outcomes of Pre-operative Oral Antibiotics vs no Antibiotics in Elective Colorectal Surgeries in Children
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.
Read more
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.
Read the 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.
- Being tested
- oral antibiotics, No Oral Antibiotics
- Keywords
- pediatric, colorectal, colostomy, duhamel, closure, hirschprung's disease, anorectal malformation, soave pull through, swenson, abdomino-perineal pull through, perineal injury, perineal wounds, ARM, Bowel preparation, oral antibiotics
- Medical subject headings
- Anorectal Malformations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral antibioticsBehavioural
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 AntibioticsBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Oral Antibiotics in ARM | Experimental | 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 Receives: Behavioral: oral antibiotics |
| No Oral Antibiotics in ARM | Active comparator | Patients of anorectal malformation in this group will receive 3-day mechanical gut preparation and no oral antibiotics will be given before surgery Receives: Behavioral: No Oral Antibiotics |
| Oral Antibiotics in Hirschprung's Disease | Experimental | 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 Receives: Behavioral: oral antibiotics |
| No Oral Antibiotics in Hirschsprung's Disease | Active comparator | Patients of Hirschsprung's disease in this group will receive 3-day mechanical gut preparation and no oral antibiotics will be given before surgery Receives: Behavioral: No Oral Antibiotics |
| Oral Antibiotics in Others | Experimental | 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 Receives: Behavioral: oral antibiotics |
| No Oral Antibiotics in Others | Active comparator | 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 Receives: Behavioral: No Oral Antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: From day of surgery till 3 weeks post operatively
Secondary outcomes (2)
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.
Measured: 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.
Measured: from 1st day of surgery till 3 weeks post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start6 Jan 2025
- Primary completionJul 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel Cleansing Prior to Clinical ProceduresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Muhammad Zubair Shoukat
- Sponsor type
- University, hospital or other
- Collaborators
- University of Child Health Sciences and Children's Hospital, Lahore
- Responsible party
- Sponsor-investigator, Muhammad Zubair Shoukat, University of Child Health Sciences and Children's Hospital, Lahore
- Investigators
- Mudassar Naveed, MBBS, Principal investigator, University of Child Health sciences & The Children's Hospital, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07713433
- Sponsor's protocol ID
- 952/CH-UCHS
- Acronym
- PEACO
- Status last verified
- Jul 2026
- First submitted
- 15 Jun 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Outcomes of Pre-operative Oral Antibiotics vs no Antibiotics in Elective Colorectal Surgeries in Children
- ClinicalTrials.gov ID
- NCT07713433
- Acronym / sponsor ID
- PEACO / 952/CH-UCHS
- Keywords
- pediatric, colorectal, colostomy, duhamel, closure, hirschprung's disease, anorectal malformation, soave pull through
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Muhammad Zubair ShoukatUniversity, hospital or other
- Collaborators
- University of Child Health Sciences and Children's Hospital, Lahore
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Oral Antibiotics in ARM | Experimental | Behavioral: oral antibioticsPatients 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 |
| No Oral Antibiotics in ARM | Active comparator | Behavioral: No Oral AntibioticsPatients of anorectal malformation in this group will receive 3-day mechanical gut preparation and no oral antibiotics will be given before surgery |
| Oral Antibiotics in Hirschprung's Disease | Experimental | Behavioral: oral antibioticsPatients 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 |
| No Oral Antibiotics in Hirschsprung's Disease | Active comparator | Behavioral: No Oral AntibioticsPatients of Hirschsprung's disease in this group will receive 3-day mechanical gut preparation and no oral antibiotics will be given before surgery |
| Oral Antibiotics in Others | Experimental | Behavioral: oral antibioticsPatients 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 |
| No Oral Antibiotics in Others | Active comparator | Behavioral: No Oral AntibioticsPatients 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 |
Who may qualify
- Ages
- 1 year to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children with colostomy planned for colostomy closure or pull through procedure for conditions including
- Anorectal malformation
- Hirschsprung's Disease
- Perianal Infections
- Perineal Trauma
Key exclusion criteria (3 listed)
- Children with small bowel stomas
- poor general condition (Malnutrition, immunodeficiency)
- Previous attempt at repair of colostomy (Reversal/Pull through)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral antibioticsPatients in this group will receive preoperative mechanical bowel preparation for 3 days and oral antibiotics including Metronidazole and Ciprofloxacin one day before surgery | Behavioural | Oral Antibiotics in ARM, Oral Antibiotics in Hirschprung's Disease, Oral Antibiotics in Others |
| No Oral AntibioticsPatients 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 | Behavioural | No Oral Antibiotics in ARM, No Oral Antibiotics in Hirschsprung's Disease, No Oral Antibiotics in Others |
Primary outcome
Incidence of Anastomotic Leak
Time frame: Within three weeks of surgery
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
Time frame: From day of surgery till 3 weeks post operatively
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)
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: 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
Related trials for Bowel Cleansing Prior to Clinical Procedures
RecruitingPhase 3
A Study to Investigate Bowel Cleansing With PLENVU® Compared to Sodium Picosulfate in Participants Aged 1 to < 18 Years of Age in Preparation for Colonoscopy
Bowel Cleansing Prior to Clinical Procedures
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mudassar Naveed, MBBS principal investigator
University of Child Health sciences & The Children's Hospital, Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral antibiotics and No Oral Antibiotics in people with Bowel Cleansing Prior to Clinical Procedures and Colorectal Anastomosis, run by Muhammad Zubair Shoukat at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mudassar Naveed, MBBS (+923214977599, mudassarnaveed81@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Anastomotic Leak (time frame: Within three weeks of surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.