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NCT Number: NCT07283952

Diverting Ileostomy and Transverse Colostomy Comparative Study

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.

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Key information

Conditions

Ileostomy Colorectal Surgery Colostomy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 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.

Primary outcomes

  1. Number of Participants With Clinically or Radiologically Confirmed Anastomotic Leak

    Time frame: From index colorectal surgery to 30 days after surgery

    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.

  2. Severity of Anastomotic Leak Assessed by Clavien-Dindo Classification

    Time frame: From index colorectal surgery to 30 days after surgery

    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.

  3. Number of Participants With Anastomotic Leak Requiring Surgical Management

    Time frame: From index colorectal surgery to 30 days after surgery

    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.

Secondary outcomes

  1. Intraoperative Blood Loss During Index Surgery

    Time frame: Intraoperative period of 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.

  2. Number of Participants With Postoperative Bleeding Requiring Transfusion or Intervention

    Time frame: From index colorectal surgery to 30 days after surgery

    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.

  3. Operative Time for Index Surgery

    Time frame: Intraoperative period of 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.

  4. Length of Hospital Stay After Index Surgery

    Time frame: Baseline

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed E T Mahmoud, bachelor

CONTACT

[email protected]

00201019220327

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Diverting Ileostomy Verses Transverse Colostomy in Colorectal Surgery

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 16, 2025
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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