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Safety & Efficacy of a Novel Asymmetrical Linear Stapler (NALS) for Securing Distal Resection Margin in Laparoscopic Rectal Cancer Surgery: Pilot Study
Sponsor: Seoul National University Hospital
Summary
Through the use of a novel asymmetrical linear stapler (NALS, Meditulip co. Ltd.), we aim to prove that true distal margins greater than 1cm may be harvested more readily and easily compared to the conventional staplers. The study is designed as a pilot RCT of 30 patients in each group, with the primary outcome of distal margin length \>1cm. Secondary outcomes include anastomosis dehiscence and time taken to harvest the distal margin.
Key Details
Gender
All
Age Range
19 Years - 79 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2025-03-01
Completion Date
2025-09-30
Last Updated
2024-11-29
Healthy Volunteers
No
Conditions
Interventions
Novel asymmetrical linear stapler
Novel asymmetrical linear stapler
Signia™
Signia™
Locations (1)
Seoul National University Hospital
Seoul, Jongro-gu, South Korea