Not Yet RecruitingNot Applicable

Safety & Efficacy of a Novel Asymmetrical Linear Stapler (NALS) for Securing Distal Resection Margin in Laparoscopic Rectal Cancer Surgery: Pilot Study

South Korea60 participantsStarted 2025-03-01

Plain-language 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.

Who can participate

Age range19 Years – 79 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Rectal cancer patients between the age of 19\~79, who require anus preserving laparoscopic rectum resection surgery Exclusion Criteria: * Advanced rectal cancer that invades surrounding structures or has known distant metastasis * Uncontrolled comorbidities * Patients otherwise considered unsuitable for the study

What they're measuring

True distal margin length > 1cm

Timeframe: Intraoperative

Trial details

NCT IDNCT06709170

SponsorSeoul National University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-31

Contact for this trial

Jae Hyun Park, MD

+82 10 7233 3820 parkjhyun719@naver.com

View on ClinicalTrials.gov More Colo-rectal Cancer trials