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NCT Number: NCT06546176

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

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.

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Key information

Conditions

End to End Anastomosis Colonic Diseases Colonic Neoplasms Colorectal Anastomosis Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms End to Anterior Rectal Wall Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms Sigmoid Cancer Sigmoid Diseases Sigmoid Neoplasms Upper Rectal Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University

Cairo, Egypt

Location status: Recruiting

Location contact

Ahmed A Abbas, MD

SUB_INVESTIGATOR

Ahmed A Eldein, MD

SUB_INVESTIGATOR

Asmaa F Hussein, Master

CONTACT

[email protected]

00201009376712

Tasnim R Naeem, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Anastomotic leakage

    Time frame: 5 days after surgery

    Anastomotic leakage will be measured for 5 days after surgery

Secondary outcomes

  1. Operative time

    Time frame: Until the procedure is completed

    Operative time will be measured from the start of surgery till the end of surgery.

  2. Hospital stay

    Time frame: 28 days postoperative

    Hospital stay will be assessed from admission till discharge from hospital

  3. Time of bowel function

    Time frame: 7 days postoperative

    Time of bowel function will be assessed

  4. Wound complications

    Time frame: 7 days postoperative

    Wound complications will be recorded as bleeding and infection.

Study contacts

Contact information is provided by the study sponsor or research team.

Asmaa F Hussein, Master

CONTACT

[email protected]

00201009376712

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 9, 2024
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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