Purse-String Versus Linear Closure After Ileostomy Reversal

NCT07892404 | Completed

• 1 other identifier: ILEO-PSLC-2026
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized study compared two wound closure and wound care protocols after reversal of a diverting ileostomy in adults previously treated surgically for rectal cancer. Participants were assigned to either purse-string skin closure with central drainage access or linear skin closure with marginal drainage access. Both protocols included temporary passive drainage and standardized postoperative wound irrigation. The study evaluated postoperative wound healing and wound-related outcomes during 30 days of follow-up. The hypothesis was that the purse-string protocol would be associated with fewer clinically important wound complications than the linear closure protocol.

Conditions

Diverting Ileostomy; Rectal Cancer

Keywords

Ileostomy Reversal; Stoma Closure; Purse-String Closure; Linear Skin Closure; Surgical Wound Healing; Wound Management; Southampton Wound Assessment Scale

Outcome Measures

Primary Outcomes (1)

• Participants With a Southampton Wound Grade III-V Event

  Number of participants with at least one Southampton Wound Assessment Scale grade III-V event at scheduled postoperative assessments. Wounds were assessed on postoperative day 2, at hospital discharge, postoperative day 7, and postoperative day 30. The highest Southampton grade recorded across these scheduled assessments was used to determine whether the participant met the primary outcome.

  From surgery through postoperative day 30; assessed on postoperative day 2, at discharge, postoperative day 7, and postoperative day 30

Study Arms (2)

Purse-String Closure With Drainage Access

EXPERIMENTAL

Participants underwent purse-string skin closure after diverting ileostomy reversal. A circular subcuticular purse-string suture was used, leaving a central opening of no more than 5 mm for drainage and postoperative wound irrigation. A temporary passive rubber drain was placed through the opening and removed on postoperative day 1.

Procedure: Linear Wound Management Protocol

Linear Closure With Drainage Access

ACTIVE COMPARATOR

Participants underwent linear skin closure after diverting ileostomy reversal. The skin was closed with interrupted sutures, leaving a marginal opening of no more than 5 mm for drainage and postoperative wound irrigation. A temporary passive rubber drain was placed through the opening and removed on postoperative day 1.

Procedure: Linear Wound Management Protocol

Interventions

Linear Wound Management Protocol PROCEDURE

After diverting ileostomy reversal, the skin was closed with interrupted sutures, leaving a marginal opening no greater than 5 mm for drainage and postoperative irrigation. A temporary passive rubber drain was placed through the opening and removed on postoperative day 1. The wound cavity was irrigated once daily with 20 mL of 0.05% aqueous chlorhexidine during hospitalization and for three days after discharge, followed by dry wound care.

Linear Closure With Drainage Access; Purse-String Closure With Drainage Access

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years or older.
• History of low anterior resection for rectal cancer with creation of a diverting ileostomy.
• Planned ileostomy reversal 35-40 days after the primary operation.
• Colorectal anastomotic integrity and patency confirmed before reversal by contrast enema and rectosigmoidoscopy.
• Written informed consent to participate.

You may not qualify if:

• Planned ileostomy reversal outside the 35-40-day interval.
• Clinical or instrumental evidence of colorectal anastomotic leakage.
• Active infection.
• Severe decompensated comorbidity.
• Refusal to participate.

Sponsors & Collaborators

• Dnipro Regional Clinical Oncology Dispensary: lead

Study Sites (1)

Dnipro Regional Clinical Oncology Dispensary

Dnipro, Выберите Область, 49100, Ukraine

Location

Related Publications (3)

• O'Leary DP, Carter M, Wijewardene D, Burton M, Waldron D, Condon E, Coffey JC, Peirce C. The effect of purse-string approximation versus linear approximation of ileostomy reversal wounds on morbidity rates and patient satisfaction: the 'STOMA' trial. Tech Coloproctol. 2017 Nov;21(11):863-868. doi: 10.1007/s10151-017-1713-x. Epub 2017 Nov 17.

  PMID: 29149428 RESULT

• Lee JT, Marquez TT, Clerc D, Gie O, Demartines N, Madoff RD, Rothenberger DA, Christoforidis D. Pursestring closure of the stoma site leads to fewer wound infections: results from a multicenter randomized controlled trial. Dis Colon Rectum. 2014 Nov;57(11):1282-9. doi: 10.1097/DCR.0000000000000209.

  PMID: 25285695 RESULT

• Dusch N, Goranova D, Herrle F, Niedergethmann M, Kienle P. Randomized controlled trial: comparison of two surgical techniques for closing the wound following ileostomy closure: purse string vs direct suture. Colorectal Dis. 2013 Aug;15(8):1033-40. doi: 10.1111/codi.12211.

  PMID: 23634717 RESULT

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Dmytro Y Savenkov, MD, PhD

  Dnipropetrovsk regional oncology dispensary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2026
• First Posted: October 23, 2026
• Study Start: June 10, 2026
• Primary Completion: August 10, 2026
• Study Completion: August 10, 2026
• Last Updated: October 23, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data and supporting information will be available beginning after publication of the primary study results and will remain available for 5 years after publication.
• Access Criteria: Requests will be considered by the corresponding author and study investigators. Access may be granted to qualified researchers for scientifically justified purposes, subject to applicable ethical, institutional, and privacy requirements. Requests should include a brief research proposal and the intended use of the data. Deidentified data and supporting documents may be provided electronically after approval of the request and, where appropriate, completion of a data use agreement.

Locations

UA (1)