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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. 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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A Colostomy Reversal | Active Comparator | Patients in this group will not receive any mechanical bowel preparation prior to undergoing colostomy reversal. |
|
| Group B Colostomy Reversal | Active Comparator | Patients in this group will receive 3 days bowel preparation prior to undergoing colostomy reversal. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Mechanical Bowel Preparation | Procedure | In this group patients will not receive any mechanical bowel preparation prior to undergoing colostomy reversal. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | At 7 days after surgery and then at 30 days after surgery. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aziz A Chattha, MBBS, FCPS | Contact | 923215986466 | azizchattha@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Child Health Sciences, The Children's Hospital | Recruiting | Lahore | Punjab Province | 54600 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27011524 | Background | 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. | |
| 28433362 | Background | Ares 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. |
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all IPD that underlie results in a publication after deidentification (text, table, figures and appendices)
Immediately following publication. No end date.
Data will be available to researchers who provide a methodologically sound proposal in order to achieve the aims mentioned in the approved proposal. Proposals should be directed to email : azizchattha@hotmail.com
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 3, 2025 |
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| Mechanical Bowel Preparation | Procedure | In this group patients will receive 3 days mechanical bowel preparation prior to undergoing colostomy reversal. |
|
| Mar 21, 2025 |
| Prot_SAP_000.pdf |