Diverting Ileostomy and Transverse Colostomy Comparative Study
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAssiut University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
• 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.
Disqualifiers
• 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.
Trial design
Design model
Parallel
Treatments tested in this trial
Diverting ileostomy
Procedure/Surgerya 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/Surgerya 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.
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: diverting ileostomyActive comparator 1 intervention
Group B: transverse colostomyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From index colorectal surgery to 30 days after surgery2
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.
Time frame
From index colorectal surgery to 30 days after surgery3
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.
Time frame
From index colorectal surgery to 30 days after surgerySecondary outcomes
1
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.
Time frame
Intraoperative period of index surgery2
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.
Time frame
From index colorectal surgery to 30 days after surgery3
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.
Time frame
Intraoperative period of index surgery4
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.
Time frame
BaselineLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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