Diverting Ileostomy and Transverse Colostomy Comparative Study

NCT07283952 | Not Yet Recruiting

• 1 other identifier: Stoma Type Comparison
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

Protective diverting stomas are frequently constructed after low anterior resection or colorectal anastomosis to mitigate the consequences of anastomotic leakage, one of the most feared complications in colorectal surgery. Both loop ileostomy (LI) and loop transverse colostomy (TC) are accepted methods of diversion. Randomized and observational studies have shown that faecal diversion significantly reduces the clinical severity of leaks and the need for reoperation compared with no diversion. The choice between LI and TC remains controversial. Loop ileostomy is technically straightforward and associated with shorter operative time and fewer septic complications at closure. However, it carries specific risks, including high-output stoma, dehydration, electrolyte imbalance, and renal impairment, which may lead to hospital readmissions. Conversely, loop transverse colostomy is associated with fewer fluid and electrolyte issues, but has higher rates of prolapse, skin irritation, and wound complications at closure. Meta-analyses comparing LI and TC indicate no clear superiority, with each approach demonstrating distinct patterns of morbidity. Some randomized trials have suggested lower major morbidity with LI, while others found no significant difference. Given the heterogeneity of outcomes and limited high-quality, adequately powered trials, further randomized evidence is needed to guide optimal stoma selection in colorectal surgery.

Conditions

Ileostomy; Colostomy; Colorectal Surgery

Keywords

Diverting Ileostomy; Transverse Colostomy; Colorectal Surgery

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Clinically or Radiologically Confirmed Anastomotic Leak

  Count of participants in each arm who develop an anastomotic leak confirmed by clinical signs (such as fever, abdominal pain, peritonitis, or purulent discharge) and/or by contrast-enhanced radiological imaging. The unit of measure will be number of participants.

  From index colorectal surgery to 30 days after surgery

• Severity of Anastomotic Leak Assessed by Clavien-Dindo Classification

  Distribution of Clavien-Dindo complication grades among participants who develop an anastomotic leak in each arm. The unit of measure will be number of participants in each Clavien-Dindo grade category.

  From index colorectal surgery to 30 days after surgery

• Number of Participants With Anastomotic Leak Requiring Surgical Management

  Count of participants with anastomotic leak who require operative intervention, including re-laparotomy, laparoscopic washout, stoma revision, or creation of a new stoma. The unit of measure will be number of participants.

  From index colorectal surgery to 30 days after surgery

Secondary Outcomes (4)

• Intraoperative Blood Loss During Index Surgery

  Intraoperative period of index surgery

• Number of Participants With Postoperative Bleeding Requiring Transfusion or Intervention

  From index colorectal surgery to 30 days after surgery

• Operative Time for Index Surgery

  Intraoperative period of index surgery

• Length of Hospital Stay After Index Surgery

  Baseline

Study Arms (2)

diverting ileostomy

ACTIVE COMPARATOR

Procedure: Diverting ileostomy

transverse colostomy

ACTIVE COMPARATOR

Procedure: Diverting Transverse Colostomy

Interventions

Diverting ileostomy PROCEDURE

a surgical procedure in which the a segment of the ileum is mobilized and placed as a stoma diverting technique to protect any distal anastomosis

diverting ileostomy

Diverting Transverse Colostomy PROCEDURE

a surgical procedure in which the a segment of the transverse colon is mobilized and placed as a stoma diverting technique to protect any distal anastomosis.

transverse colostomy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ≥18 years undergoing elective low anterior resection or coloanal anastomosis for benign or malignant colorectal disease.
• Patients for whom the surgeon has decided that a diverting stoma is required such as emergency resection and anastomosis cases where a covering stoma is indicated.
• Ability to provide informed consent.

You may not qualify if:

• Patients with pre-existing stoma.
• Severe comorbidities precluding stoma creation (e.g., advanced renal failure, uncontrolled cardiac disease).
• Patients with extensive peritoneal carcinomatosis or unresectable disease.
• Pregnant or lactating women.
• Inability to comply with follow-up or provide informed consent.

Sponsors & Collaborators

• Assiut University: lead

Study Officials

• Mohamed H Othman, Doctorate

  Assiut University

  STUDY CHAIR

• Mohamed abulfetouh, Doctorate

  Assiut University

  STUDY DIRECTOR

• Ahmed G Hemdan, doctorate

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Ahmed E T Mahmoud, bachelor

CONTACT

00201019220327; aet.mah1699@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at the Department of General Surgery, Assiut University

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 16, 2025
• Study Start: January 30, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: December 16, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR