Safety & Efficacy of a Novel Asymmetrical Linear Stapler (NALS) for Securing Distal Resection Margin in Laparoscopic Rectal Cancer Surgery: Pilot Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Novel asymmetrical linear stapler, Signia™.
- Who it may be relevant to
- Registry conditions: Colo-rectal Cancer. Basic parameters: 19 years — 79 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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).
Interventions
- Device Novel asymmetrical linear stapler
Novel asymmetrical linear stapler - Device Signia™
Signia™
Primary outcome measures
- True distal margin length > 1cm [Time frame: Intraoperative]
Secondary outcome measures (4)
- Early anastomosis leakage [Time frame: From randomization until the date of first documented sign of leakage, assessed up to 30 days]
- Time to harvest margin [Time frame: 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 [Time frame: Intraoperative (at the time point of the frozen section pathology report)]
- Sphincter preservation rate [Time frame: From randomization until the end of clinical data collection, assessed up to 120 days.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Seoul National University Hospital — Seoul
Identifiers
NCT: NCT06709170 · 2023-3198