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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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06546176
Enrollment
40
Registered
2024-08-09
Start date
2023-09-01
Completion date
2024-09-01
Last updated
2024-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHEREnd 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.

OTHEREnd 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.

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Anastomotic leakage5 days after surgeryAnastomotic leakage will be measured for 5 days after surgery

Secondary

MeasureTime frameDescription
Operative timeUntil the procedure is completedOperative time will be measured from the start of surgery till the end of surgery.
Hospital stay28 days postoperativeHospital stay will be assessed from admission till discharge from hospital
Time of bowel function7 days postoperativeTime of bowel function will be assessed
Wound complications7 days postoperativeWound complications will be recorded as bleeding and infection.

Countries

Egypt

Contacts

Primary ContactAsmaa F Hussein, Master
asmaafathi@med.asu.edu.eg00201009376712

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026