Diverting Ileostomy and Transverse Colostomy Comparative Study

Diverting Ileostomy Verses Transverse Colostomy in Colorectal Surgery

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Surgery; Colostomy; Ileostomy
• Intervention / Treatment: Procedure: Diverting ileostomy; Procedure: Diverting Transverse Colostomy

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed E T Mahmoud, bachelor; Phone Number: 00201019220327; Email: aet.mah1699@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• • 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.

Exclusion Criteria:

• • 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: diverting ileostomy	Procedure: Diverting ileostomy; 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
Active Comparator: transverse colostomy	Procedure: Diverting Transverse Colostomy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative Blood Loss During Index Surgery	Estimated volume of blood loss during the index colorectal resection and stoma creation, as recorded in the anesthesia or operative record. The unit of measure will be milliliters.	Intraoperative period of index surgery
Number of Participants With Postoperative Bleeding Requiring Transfusion or Intervention	Count of participants who experience postoperative bleeding after index surgery that requires blood transfusion, endoscopic hemostasis, radiological embolization, or reoperation. The unit of measure will be number of participants.	From index colorectal surgery to 30 days after surgery
Operative Time for Index Surgery	Duration of the index colorectal resection and diverting stoma creation measured from skin incision to skin closure. The unit of measure will be minutes.	Intraoperative period of index surgery
Length of Hospital Stay After Index Surgery	Duration of hospitalization in days for the admission during which the index colorectal surgery and stoma creation are performed, from the day of operation to the day of discharge. The unit of measure will be days.	Baseline

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Chair: Mohamed H Othman, Doctorate, Assiut University; Study Director: Mohamed abulfetouh, Doctorate, Assiut University; Study Director: Ahmed G Hemdan, doctorate, Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): January 30, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): November 30, 2027

Study Registration Dates

• First Submitted: November 20, 2025
• First Submitted That Met QC Criteria: December 12, 2025
• First Posted (Actual): December 16, 2025

Study Record Updates

• Last Update Posted (Actual): December 16, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Colorectal Surgery; Diverting Ileostomy; Transverse Colostomy
• Other Study ID Numbers: Stoma Type Comparison

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: age, brief medical and surgical history , lab investigations and any imaging done pre or post operative
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No