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NCT06709170Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 29 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
60 (estimated)
First submitted
17 Nov 2024
Start date
1 Mar 2025
Primary completion date
31 Jul 2025
Lead sponsor
Seoul National University Hospital
NCT number
NCT06709170

What you commit to

  • Study type: Interventional
  • Planned participants: 60
  • From 1 Mar 2025 to the primary completion date, 31 Jul 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Advanced rectal cancer that invades surrounding structures or has known distant metastasis

Other

  • Uncontrolled comorbidities
  • Patients otherwise considered unsuitable for the study

Who the study is looking for

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

Age in the registry: 19 years to 79 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Seoul National University Hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.