NCT06709170

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years – 79 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Current evidence indicates distal margins of greater than 1cm from the tumor is necessary for superior oncologic outcomes. In middle to lower rectal cancer, where the tumor is close to the anus, sparing the anus whilst securing such a margin may prove difficult. Failure to secure sufficient margin length may end up in cancer recurrence, but inaccurate assessment of the margin status may also cause further unnecessary resection or failure to spare the anus. The novel asymmetrical linear stapler was designed specifically with this problem in mind, and one row of stapling was removed from the specimen side to allow easier harvesting of a undisrupted distal margin tissue for pathological evaluation. This study is a pilot RCT of 30 patients each in the novel stapler group and control group, to prove the non-inferiority in safety and superiority in harvesting the distal margin (assessed by length of margin and time to harvest).

Conditions

• Colo-rectal Cancer

Interventions

Type	Name	Description
DEVICE	Novel asymmetrical linear stapler	Novel asymmetrical linear stapler
DEVICE	Signia™	Signia™

Timeline

• Start date: 2025-03-01
• Primary completion: 2025-07-31
• Completion: 2025-09-30
• First posted: 2024-11-29
• Last updated: 2024-11-29

Locations

1 site across 1 country: South Korea