Diverting Ileostomy and Transverse Colostomy Comparative Study

Официальное название

Diverting Ileostomy Verses Transverse Colostomy in Colorectal Surgery

Обзор

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.

Вмешательства

• Процедура 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
• Процедура 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.

Первичные конечные точки

• Number of Participants With Clinically or Radiologically Confirmed Anastomotic Leak [Срок оценки: From index colorectal surgery to 30 days after surgery]
• Severity of Anastomotic Leak Assessed by Clavien-Dindo Classification [Срок оценки: From index colorectal surgery to 30 days after surgery]
• Number of Participants With Anastomotic Leak Requiring Surgical Management [Срок оценки: From index colorectal surgery to 30 days after surgery]

Вторичные конечные точки (4)

• Intraoperative Blood Loss During Index Surgery [Срок оценки: Intraoperative period of index surgery]
• Number of Participants With Postoperative Bleeding Requiring Transfusion or Intervention [Срок оценки: From index colorectal surgery to 30 days after surgery]
• Operative Time for Index Surgery [Срок оценки: Intraoperative period of index surgery]
• Length of Hospital Stay After Index Surgery [Срок оценки: Baseline]

Критерии участия

Критерии включения

• • 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.

Критерии исключения

• • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07283952 · Stoma Type Comparison

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗