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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое End to end with Omega suture
  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.
• Другое End to anterior rectal wall
  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.

Первичные конечные точки

• Anastomotic leakage [Срок оценки: 5 days after surgery]

Вторичные конечные точки (4)

• Operative time [Срок оценки: Until the procedure is completed]
• Hospital stay [Срок оценки: 28 days postoperative]
• Time of bowel function [Срок оценки: 7 days postoperative]
• Wound complications [Срок оценки: 7 days postoperative]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

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

Египет · 1 центр

• Ain Shams University — Cairo

Идентификаторы

NCT: NCT06546176 · 13/8/2023

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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