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

Not Applicable
Recruiting
Conditions
End to End Anastomosis
Colorectal Anastomosis
End to Anterior Rectal Wall
Sigmoid Cancer
Upper Rectal Cancer
Interventions
Other: End to anterior rectal wall
Other: End to end with Omega suture
Registration Number
NCT06546176
Lead Sponsor
Ain Shams University
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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
40
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Group B (end to anterior rectal wall)End to anterior rectal wallA 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 A(end to end with Omega suture)End to end with Omega sutureAfter 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.
Primary Outcome Measures
NameTimeMethod
Anastomotic leakage5 days after surgery

Anastomotic leakage will be measured for 5 days after surgery

Secondary Outcome Measures
NameTimeMethod
Operative timeUntil the procedure is completed

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

Hospital stay28 days postoperative

Hospital stay will be assessed from admission till discharge from hospital

Wound complications7 days postoperative

Wound complications will be recorded as bleeding and infection.

Time of bowel function7 days postoperative

Time of bowel function will be assessed

Trial Locations

Locations (1)

Ain Shams University

🇪🇬

Cairo, Egypt

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