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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

NCT ID: NCT06709170

Last Updated: 2024-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-01

Study Completion Date

2025-09-30

Brief Summary

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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

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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

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Colo-rectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Novel asymmetrical linear stapler

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.

Group Type EXPERIMENTAL

Novel asymmetrical linear stapler

Intervention Type DEVICE

Novel asymmetrical linear stapler

Control

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)

Group Type ACTIVE_COMPARATOR

Signia™

Intervention Type DEVICE

Signia™

Interventions

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Novel asymmetrical linear stapler

Novel asymmetrical linear stapler

Intervention Type DEVICE

Signia™

Signia™

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role collaborator

Seoul National University Boramae Hospital

OTHER

Sponsor Role collaborator

National Cancer Center, Korea

OTHER_GOV

Sponsor Role collaborator

Kyungpook National University Chilgok Hospital

OTHER

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ryoo, Seung-Bum

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Hospital

Seoul, Jongro-gu, South Korea

Site Status

Countries

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South Korea

Central Contacts

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Jae Hyun Park, MD

Role: CONTACT

[email protected]
+82 10 7233 3820

Seung-Bum Ryoo, MD PhD

Role: CONTACT

[email protected]

Other Identifiers

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2023-3198

Identifier Type: -

Identifier Source: org_study_id