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NOT YET RECRUITING
NCT06709170
NA

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

View on ClinicalTrials.gov

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

Interventions

DEVICE

Novel asymmetrical linear stapler

Novel asymmetrical linear stapler

DEVICE

Signia™

Signia™

Locations (1)

Seoul National University Hospital

Seoul, Jongro-gu, South Korea