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

Seoul National University

Status: Not yet enrolling

Conditions: Colo-rectal Cancer

Treatments: Device: Signia™; Device: Novel asymmetrical linear stapler

Study type: Interventional

Funder types: Other

Identifiers

NCT06709170

2023-3198

Details and patient eligibility

About

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.

Full 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).

Enrollment: 60 estimated patients

Sex: All

Ages: 19 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Novel asymmetrical linear stapler

Experimental group

Description:

Rectal cancer patients randomized to this group will use the novel asymmetrical linear stapler for distal rectum transection, and with 2 rows of stapler lines instead of 3, sufficient tissue is left on the specimen side to harvest the true distal margin for accurate pathological evaluation.

Treatment:

Device: Novel asymmetrical linear stapler

Control

Active Comparator group

Description:

Rectal cancer patients in the control group will use the conventional Signia™ stapler (Medtronic co.) as routinely used in the centers involved with the study, which has triple stapling technology (3 rows of stapler lines on both sides of transection)

Treatment:

Device: Signia™