Colostomy - StomaNCT06902116
Comparison of Outcome of Three Days Bowel Preparation vs No Bowel Preparation in Patients of Colostomy Reversal
A study testing No Mechanical Bowel Preparation and Mechanical Bowel Preparation in people with Colostomy - Stoma and Bowel Preparation, run by University of Child Health Sciences and Children's Hospital, Lahore at 1 site in Pakistan.
Trial summary
The goal of this trial is to compare the outcomes of colostomy reversal with three days bowel preparation with no bowel preparation in terms of anastomotic leakage, surgical site infection and hospital stay. The important question this trial aims to answer is: 1. Read more about this study
- Who is it for?
- Ages 1 year to 15 years
- Conditions the study is for
- Colostomy - Stoma, Bowel Preparation, BOWEL ANASTOMOSIS
- What is being tested?
- No Mechanical Bowel Preparation and Mechanical Bowel Preparation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePakistan
- Study dates
- 8 Jan 2025to Mar 2027
- 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 between 1-15 years of age
Who cannot join
- Malnourished
- Previous history of colostomy site anastomotic leakage
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, Punjab Province, 54600
Muhammad Z Shoukat, MBBS, FCPS, 923126446646, zubairshaukat@outlook.com
Aziz Ahmad Chattha, MBBS, FCPS
About this study
The goal of this trial is to compare the outcomes of colostomy reversal with three days bowel preparation with no bowel preparation in terms of anastomotic leakage, surgical site infection and hospital stay.
The important question this trial aims to answer is:
Read more
- is there any difference in outcomes after colostomy reversal with three days gut preparation pre-operatively vs no gut preparation?
This prospective Randomized Controlled trial will include children with colostomy divided into two groups:
Group A: No Mechanical Bowel Preparation Group B: 3 Days Mechanical Bowel Preparation Participants of Group A will be admitted 1 day prior to surgery date as they require no special preparation before surgery. They will be made Nil per oral 6 hours prior to surgery. Group B participants will be admitted 3 days prior to surgery. These participants will be restricted to fiber rich diet and milk 72 hours prior to surgery. They will be shifted to clear liquids 24 hours prior to surgery. Normal saline enema will be given 8 hourly through the stoma as well as per rectally by the trained person.
Comparative outcomes will be:
- Anastomotic leakage
- Hospital Stay
- Wound infection
- Conditions
- Colostomy - Stoma, Bowel Preparation, BOWEL ANASTOMOSIS
- Being tested
- No Mechanical Bowel Preparation, Mechanical Bowel Preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Mechanical Bowel PreparationProcedure or surgery
In this group patients will not receive any mechanical bowel preparation prior to undergoing colostomy reversal.
Mechanical Bowel PreparationProcedure or surgery
In this group patients will receive 3 days mechanical bowel preparation prior to undergoing colostomy reversal.
| Study group | Role | What they receive |
|---|---|---|
| Group A Colostomy Reversal | Active comparator | Patients in this group will not receive any mechanical bowel preparation prior to undergoing colostomy reversal. Receives: Procedure: No Mechanical Bowel Preparation |
| Group B Colostomy Reversal | Active comparator | Patients in this group will receive 3 days bowel preparation prior to undergoing colostomy reversal. Receives: Procedure: Mechanical Bowel Preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anastomotic Leakage
In this outcome measure, it will be seen if there is any difference in both intervention in terms of number of participants with anastomotic (part of gut where two separate ends of colon have been sutured with each other) leakage.
Measured: 5-10 days post operatively.
Wound infection
In this outcome variable, number of participants with infection at the site of colostomy reversal wound will be compared between both groups.
Measured: At 7 days after surgery and then at 30 days after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start8 Jan 2025
- Primary completionJan 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colostomy - StomaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Child Health Sciences and Children's Hospital, Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aziz Ahmad Chattha, University of Child Health Sciences and Children's Hospital, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06902116
- Sponsor's protocol ID
- 1038/CH-UCHS
- Status last verified
- Jul 2026
- First submitted
- 13 Feb 2025
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication after deidentification (text, table, figures and appendices)
Publications
Cavusoglu YH, Karaman A, Afsarlar CE, Karaman I, Erdogan D, Ozguner IF. Ostomy Closures in Children: Variations in Perioperative Care Do Not Change the Outcome. Indian J Surg. 2015 Dec;77(Suppl 3):1131-6. doi: 10.1007/s12262-015-1212-0. Epub 2015 Jan 19.
PubMed 27011524Ares GJ, Helenowski I, Hunter CJ, Madonna M, Reynolds M, Lautz T. Effect of preadmission bowel preparation on outcomes of elective colorectal procedures in young children. J Pediatr Surg. 2018 Apr;53(4):704-707. doi: 10.1016/j.jpedsurg.2017.03.060. Epub 2017 Mar 30.
PubMed 28433362
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Outcome of Three Days Bowel Preparation vs No Bowel Preparation in Patients of Colostomy Reversal
- ClinicalTrials.gov ID
- NCT06902116
- Acronym / sponsor ID
- 1038/CH-UCHS
- Conditions
- Colostomy - Stoma, Bowel Preparation, BOWEL ANASTOMOSIS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Child Health Sciences and Children's Hospital, LahoreUniversity, hospital or other
- Study start
- 8 Jan 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 30 Mar 2025 (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.
The goal of this trial is to compare the outcomes of colostomy reversal with three days bowel preparation with no bowel preparation in terms of anastomotic leakage, surgical site infection and hospital stay.
The important question this trial aims to answer is:
- is there any difference in outcomes after colostomy reversal with three days gut preparation pre-operatively vs no gut preparation?
This prospective Randomized Controlled trial will include children with colostomy divided into two groups:
Group A: No Mechanical Bowel Preparation Group B: 3 Days Mechanical Bowel Preparation Participants of Group A will be admitted 1 day prior to surgery date as they require no special preparation before surgery. They will be made Nil per oral 6 hours prior to surgery. Group B participants will be admitted 3 days prior to surgery. These participants will be restricted to fiber rich diet and milk 72 hours prior to surgery. They will be shifted to clear liquids 24 hours prior to surgery. Normal saline enema will be given 8 hourly through the stoma as well as per rectally by the trained person.
Comparative outcomes will be:
- Anastomotic leakage
- Hospital Stay
- Wound infection
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A Colostomy Reversal | Active comparator | Procedure: No Mechanical Bowel PreparationPatients in this group will not receive any mechanical bowel preparation prior to undergoing colostomy reversal. |
| Group B Colostomy Reversal | Active comparator | Procedure: Mechanical Bowel PreparationPatients in this group will receive 3 days bowel preparation prior to undergoing colostomy reversal. |
Who may qualify
- Ages
- 1 year to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children with colostomy between 1-15 years of age
Key exclusion criteria (2 listed)
- Malnourished
- Previous history of colostomy site anastomotic leakage
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 |
|---|---|---|
| No Mechanical Bowel PreparationIn this group patients will not receive any mechanical bowel preparation prior to undergoing colostomy reversal. | Procedure or surgery | Group A Colostomy Reversal |
| Mechanical Bowel PreparationIn this group patients will receive 3 days mechanical bowel preparation prior to undergoing colostomy reversal. | Procedure or surgery | Group B Colostomy Reversal |
Primary outcome
Anastomotic Leakage
Time frame: 5-10 days post operatively.
In this outcome measure, it will be seen if there is any difference in both intervention in terms of number of participants with anastomotic (part of gut where two separate ends of colon have been sutured with each other) leakage.
Wound infection
Time frame: At 7 days after surgery and then at 30 days after surgery.
In this outcome variable, number of participants with infection at the site of colostomy reversal wound will be compared between both groups.
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 6 Jul 2026.
- Background: PubMed 27011524Cavusoglu YH, Karaman A, Afsarlar CE, Karaman I, Erdogan D, Ozguner IF. Ostomy Closures in Children: Variations in Perioperative Care Do Not Change the Outcome. Indian J Surg. 2015 Dec;77(Suppl 3):1131-6. doi: 10.1007/s12262-015-1212-0. Epub 2015 Jan 19.
- Background: PubMed 28433362Ares GJ, Helenowski I, Hunter CJ, Madonna M, Reynolds M, Lautz T. Effect of preadmission bowel preparation on outcomes of elective colorectal procedures in young children. J Pediatr Surg. 2018 Apr;53(4):704-707. doi: 10.1016/j.jpedsurg.2017.03.060. Epub 2017 Mar 30.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication after deidentification (text, table, figures and appendices)
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No Mechanical Bowel Preparation and Mechanical Bowel Preparation in people with Colostomy - Stoma and Bowel Preparation, run by University of Child Health Sciences and Children's Hospital, Lahore 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 1 inclusion and 2 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 6 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 Aziz A Chattha, MBBS, FCPS (923215986466, azizchattha@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anastomotic Leakage (time frame: 5-10 days post operatively.). 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?
On the ClinicalTrials.gov record for NCT06902116, which also lists 2 linked publications.
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 6 Jul 2026.