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

NCT ID: NCT06546176

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2024-09-01

Brief Summary

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.

Detailed 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A(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.

Group Type: OTHER

End to end with Omega suture

Intervention Type: 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.

Group B (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.

Group Type: OTHER

End to anterior rectal wall

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Asmaa fathi

Assistant Lecturer of General Surgery, Ain Shams University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ain Shams University

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Asmaa F Hussein, Master

Role: CONTACT

asmaafathi@med.asu.edu.eg

00201009376712

Facility Contacts

Asmaa F Hussein, Master

Role: primary

asmaafathi@med.asu.edu.eg

00201009376712

Other Identifiers

13/8/2023

Identifier Type: -

Identifier Source: org_study_id