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Recruiting NCT06546176

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

No phase Interventional End to End Anastomosis Colorectal Anastomosis End to Anterior Rectal Wall Sigmoid Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: End to end with Omega suture, End to anterior rectal wall.
Who it may be relevant to
Registry conditions: End to End Anastomosis, Colorectal Anastomosis, End to Anterior Rectal Wall, Sigmoid Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official 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

Overview

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.

Interventions

  • Other 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.
  • 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.

Primary outcome measures

  • Anastomotic leakage [Time frame: 5 days after surgery]
Secondary outcome measures (4)
  • Operative time [Time frame: Until the procedure is completed]
  • Hospital stay [Time frame: 28 days postoperative]
  • Time of bowel function [Time frame: 7 days postoperative]
  • Wound complications [Time frame: 7 days postoperative]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Ain Shams University — Cairo

Identifiers

NCT: NCT06546176 · 13/8/2023

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗