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

NCT06546176 | Recruiting

• 1 other identifier: 13/8/2023
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Anastomotic leakage

  Anastomotic leakage will be measured for 5 days after surgery

  5 days after surgery

Secondary Outcomes (4)

• Operative time

  Until the procedure is completed

• Hospital stay

  28 days postoperative

• Time of bowel function

  7 days postoperative

• Wound complications

  7 days postoperative

Study Arms (2)

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.

Other: End to end with Omega suture

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.

Other: End to anterior rectal wall

Interventions

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.

Group A(end to end with Omega suture)

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.

Group B (end to anterior rectal wall)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Sigmoid Neoplasms; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colonic Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Sigmoid Diseases; Rectal Diseases

Central Study Contacts

Asmaa F Hussein, Master

CONTACT

00201009376712; asmaafathi@med.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of General Surgery, Ain Shams University

Study Record Dates

• First Submitted: August 4, 2024
• First Posted: August 9, 2024
• Study Start: September 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)