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Diverting Ileostomy and Transverse Colostomy Comparative Study

NCT ID: NCT07283952

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-30

Study Completion Date

2027-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Ileostomy Colostomy Colorectal Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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diverting ileostomy

Group Type ACTIVE_COMPARATOR

Diverting ileostomy

Intervention Type 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

transverse colostomy

Group Type ACTIVE_COMPARATOR

Diverting Transverse Colostomy

Intervention Type 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.

Interventions

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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

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Esam Ahmed Taher Mahmoud

Resident at the Department of General Surgery, Assiut University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohamed H Othman, Doctorate

Role: STUDY_CHAIR

Assiut University

Mohamed abulfetouh, Doctorate

Role: STUDY_DIRECTOR

Assiut University

Ahmed G Hemdan, doctorate

Role: STUDY_DIRECTOR

Assiut University

Central Contacts

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Ahmed E T Mahmoud, bachelor

Role: CONTACT

[email protected]
00201019220327

Other Identifiers

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Stoma Type Comparison

Identifier Type: -

Identifier Source: org_study_id