Safety & Efficacy of a Novel Asymmetrical Linear Stapler (NALS) for Securing Distal Resection Margin in Laparoscopic Rectal Cancer Surgery: Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- True distal margin length > 1cm
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rectal cancer patients between the age of 19~79, who require anus preserving laparoscopic rectum resection surgery
排除标准
- •Advanced rectal cancer that invades surrounding structures or has known distant metastasis
- •Uncontrolled comorbidities
- •Patients otherwise considered unsuitable for the study
研究组 & 干预措施
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.
干预措施: Novel asymmetrical linear stapler (Device)
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)
干预措施: Signia™ (Device)
结局指标
主要结局
True distal margin length > 1cm
时间窗: Intraoperative
True distal margin: The length of tissue from the distal edge of the specimen to the distal tumor margin in the surgical specimen
次要结局
- 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.)
研究者
Ryoo, Seung-Bum
Associate Professor
Seoul National University Hospital