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Diverting Ileostomy and Transverse Colostomy Comparative Study

A

Assiut University

Status

Not yet enrolling

Conditions

Colostomy
Colorectal Surgery
Ileostomy

Treatments

Procedure: Diverting Transverse Colostomy
Procedure: Diverting ileostomy

Study type

Interventional

Funder types

Other

Identifiers

NCT07283952
Stoma Type Comparison

Details and patient eligibility

About

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.

Enrollment

36 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

36 participants in 2 patient groups

diverting ileostomy
Active Comparator group
Treatment:
Procedure: Diverting ileostomy
transverse colostomy
Active Comparator group
Treatment:
Procedure: Diverting Transverse Colostomy

Trial contacts and locations

0

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Central trial contact

Ahmed E T Mahmoud, bachelor

Data sourced from clinicaltrials.gov

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