Clinical trial NCT06709170: Safety & Efficacy of a Novel Asymmetrical Linear Stapler (NALS) for Securing Distal Resection Margin in Laparoscopic Rectal Cancer Surgery: Pilot Study
Official title: Safety & Efficacy of a Novel Asymmetrical Linear Stapler (NALS) for Securing Distal Resection Margin in Laparoscopic Rectal Cancer Surgery: Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Colo-rectal Cancer
Keywords: Rectal cancer
Frozen sections
Margins of Excision
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Seoul National University Bundang Hospital
name: Seoul National University Boramae Hospital
name: National Cancer Center, Korea
name: Kyungpook National University Chilgok Hospital
First posted: 2024-11-29
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

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

Primary outcomes:
measure: True distal margin length > 1cm
timeFrame: Intraoperative
Secondary outcomes:
measure: Early anastomosis leakage
timeFrame: From randomization until the date of first documented sign of leakage, assessed up to 30 days
measure: Time to harvest margin
timeFrame: 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.)
measure: Specimen integrity
timeFrame: Intraoperative (at the time point of the frozen section pathology report)
measure: Sphincter preservation rate
timeFrame: From randomization until the end of clinical data collection, assessed up to 120 days.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Jongro-gu
Study officials:
References: