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

Ain Shams University

Status: Enrolling

Conditions: Upper Rectal Cancer; Sigmoid Cancer; Colorectal Anastomosis; End to End Anastomosis; End to Anterior Rectal Wall

Treatments: Other: End to end with Omega suture; Other: End to anterior rectal wall

Study type: Interventional

Funder types: Other

Identifiers

NCT06546176

13/8/2023

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Group A(end to end with Omega suture)

Other group

Description:

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.

Treatment:

Other: End to end with Omega suture

Group B (end to anterior rectal wall)

Other group

Description:

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.

Treatment:

Other: End to anterior rectal wall