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临床试验/NCT06546176
NCT06546176招募中不适用

Comparative Study Between End to End Anastomosis With Omega Suture Versus End to Anterior Rectal Wall In Colorectal Anastomosis in Sigmoid and Upper Rectal Cancer

Ain Shams University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Anastomotic leakage

研究概览

简要总结

The aim of this study is to compare end to end anastomosis with omega suture versus end to anterior rectal wall in colorectal anastomosis as regard post operative anastomotic leakage, bowel function, operative time and intra operative blood loss.

详细描述

Colorectal cancer has been reported to be the 3rd most common and the second most deadly cancer world wide.

Anterior resection is the gold standard operation for both rectal and recto-sigmoid cancer with considering oncological safety maintenance to be the most important goal which can be achieved by keeping abundant resection margin and ensuring anastomotic safety, despite the technical difficulties of working in a narrow deep pelvis.

Understanding the characteristics of each anastomotic technique and establishing a stable anastomotic procedure both are pillars in anastomotic leakage prevention.

The intersection of the linear staple line and circular staple line in conventional anastomotic way is considered a risk factor for anastomotic leakage by creating stapled corners (called "dog-ears") which considered potentially ischemic and represent the area with high incidence of anastomotic leakage. Single stapled technique using ether end to end with omega suture or end to side stapled anastomosis allows avoidance of the formation of this intersection.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients aged >18 years.
  • •Both sexes.
  • •Recto sigmoidal carcinoma.
  • •Upper rectal cancer.

排除标准

  • •Patients younger than 18 years
  • •Recurrent or non-resectable cancer
  • •Complicated cancer (e.g., obstructed or perforated)
  • •Previous left-sided colorectal surgery or anorectal surgeries
  • •Lower rectal cancer

研究组 & 干预措施

Group A(end to end with Omega suture)

Other

After the rectum was divided with a linear stapler, the circular stapler was placed allowing the anvil rod to penetrate the rectal stump near the linear stapler line. An omega suture including both ends of the linear stapler line was placed. The linear stapler line was approximated around the anvil rod of the circular stapler in an omega shape fashion as the omega suture was tied. This technique resulted in a complete resection of linear stapler line by the circular stapler.

干预措施: End to end with Omega suture (Other)

Group B (end to anterior rectal wall)

Other

A burse string suture was applied over the anvil of the circular stapler at the transection point of the descending colon using prolene 2/0.

The circular stapler introduced though the anus and its rod directed toward the anterior rectal wall and colorectal anastomosis was performed.

干预措施: End to anterior rectal wall (Other)

结局指标

主要结局

Anastomotic leakage

时间窗: 5 days after surgery

Anastomotic leakage will be measured for 5 days after surgery

次要结局

  • Time of bowel function(7 days postoperative)
  • Operative time(Until the procedure is completed)
  • Hospital stay(28 days postoperative)
  • Wound complications(7 days postoperative)

研究者

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

Asmaa fathi

Assistant Lecturer of General Surgery, Ain Shams University

Ain Shams University

研究点 (1)

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