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Trial Title:
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
Condition:
End to End Anastomosis
Colorectal Anastomosis
End to Anterior Rectal Wall
Sigmoid Cancer
Upper Rectal Cancer
Conditions: Official terms:
Rectal Neoplasms
Sigmoid Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
End to end with Omega suture
Description:
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.
Arm group label:
Group A(end to end with Omega suture)
Intervention type:
Other
Intervention name:
End to anterior rectal wall
Description:
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.
Arm group label:
Group B (end to anterior rectal wall)
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Ain Shams University
Address:
City:
Cairo
Country:
Egypt
Status:
Recruiting
Contact:
Last name:
Asmaa F Hussein, Master
Phone:
00201009376712
Email:
asmaafathi@med.asu.edu.eg
Investigator:
Last name:
Ahmed A Eldein, MD
Email:
Sub-Investigator
Investigator:
Last name:
Ahmed A Abbas, MD
Email:
Sub-Investigator
Investigator:
Last name:
Tasnim R Naeem, MD
Email:
Sub-Investigator
Start date:
September 1, 2023
Completion date:
September 1, 2024
Lead sponsor:
Agency:
Ain Shams University
Agency class:
Other
Source:
Ain Shams University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06546176
