跳至主要内容
临床试验/NCT07283952
NCT07283952尚未招募不适用

Diverting Ileostomy Verses Transverse Colostomy in Colorectal Surgery

Assiut University0 个研究点目标入组 36 人开始时间: 2026年1月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
36
主要终点
Number of Participants With Clinically or Radiologically Confirmed Anastomotic Leak

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • • 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.

排除标准

  • • 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.

结局指标

主要结局

Number of Participants With Clinically or Radiologically Confirmed Anastomotic Leak

时间窗: 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.

Severity of Anastomotic Leak Assessed by Clavien-Dindo Classification

时间窗: 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.

Number of Participants With Anastomotic Leak Requiring Surgical Management

时间窗: 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.

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Esam Ahmed Taher Mahmoud

Resident at the Department of General Surgery, Assiut University

Assiut University

相似试验