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

NCT06709170 | Not Yet Recruiting

• 1 other identifier: 2023-3198
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colo-rectal Cancer

Keywords

Rectal cancer; Frozen sections; Margins of Excision

Outcome Measures

Primary Outcomes (1)

• True distal margin length > 1cm

  True distal margin: The length of tissue from the distal edge of the specimen to the distal tumor margin in the surgical specimen

  Intraoperative

Secondary Outcomes (4)

• Early anastomosis leakage

  From randomization until the date of first documented sign of leakage, assessed up to 30 days

• Time to harvest margin

  Intraoperative (from the beginning of frozen section specimen harvest until the acquirement is completed. This process will be timed by a member of the surgical team using a timer.)

• Specimen integrity

  Intraoperative (at the time point of the frozen section pathology report)

• Sphincter preservation rate

  From randomization until the end of clinical data collection, assessed up to 120 days.

Study Arms (2)

Novel asymmetrical linear stapler

EXPERIMENTAL

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.

Device: Novel asymmetrical linear stapler

Control

ACTIVE COMPARATOR

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)

Device: Signia™

Interventions

Novel asymmetrical linear stapler DEVICE

Novel asymmetrical linear stapler

Novel asymmetrical linear stapler

Signia™ DEVICE

Signia™

Control

Eligibility Criteria

• Age: 19 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Rectal cancer patients between the age of 19\~79, who require anus preserving laparoscopic rectum resection surgery

You may not qualify if:

• Advanced rectal cancer that invades surrounding structures or has known distant metastasis
• Uncontrolled comorbidities
• Patients otherwise considered unsuitable for the study

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Seoul National University Bundang Hospital: collaborator
• Seoul National University Boramae Hospital: collaborator
• National Cancer Center, Korea: collaborator
• Kyungpook National University Chilgok Hospital: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, Jongro-gu, 03080, South Korea

Location

MeSH Terms

Conditions

Colonic Neoplasms; Rectal Neoplasms; Margins of Excision

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jae Hyun Park, MD

CONTACT

+82 10 7233 3820; parkjhyun719@naver.com

Seung-Bum Ryoo, MD PhD

CONTACT

sbryoomd@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 17, 2024
• First Posted: November 29, 2024
• Study Start: March 1, 2025
• Primary Completion: July 31, 2025
• Study Completion: September 30, 2025
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)