Transanal Total Mesorectal Excision Versus Robotic Total Mesorectal Excision for Mid and Low Rectal Cancer: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Incidence rate of achieving a composite of pathologic endpoint indicating adequate surgical resection
研究概览
简要总结
Background: Laparoscopic total mesorectal excision (TME) for rectal cancer is technically challenging because of the confined space within the pelvis. The robotic surgical system is recently introduced to overcome the limitations of laparoscopy in terms of visualization and maneuverability, but robotic surgery is expensive. Transanal total mesorectal excision (TaTME) is an emerging surgical approach that allows dissection of the most difficult part of the TME plane deep down in the pelvis using a less costly transanal platform. To date, no randomized controlled trial can be found in the literature comparing TaTME and robotic TME.
Objectives: To compare the pathologic outcomes, functional outcomes, and costs between TaTME and robotic TME for mid or low rectal cancer.
Design: Prospective, randomized, controlled, superiority trial.
Subjects: One hundred and eight consecutive patients who are clinically diagnosed with cT1-3, N0-2, M0 rectal cancer located within 12 cm of the anal verge who do not require abdominoperineal resection will be recruited.
Interventions: Patients will be randomly allocated to undergo either TaTME or robotic TME.
Outcome measures: Primary outcome: composite pathologic endpoint (complete TME, clear circumferential and distal resection margins). Secondary outcomes: conversion rate, postoperative recovery, morbidity, health-related quality of life, urosexual function, and costs.
Hypothesis: Results of the present study can provide evidence-based clarification of the efficacy and safety of TaTME for patients with mid and low rectal cancer. The results of this proposed project may have a significant impact on the future treatment strategy for mid and low rectal cancer.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consecutive patients who are diagnosed with mid or low rectal adenocarcinoma, of which the lowest margin of the tumor is located at or within 12 cm of the anal verge as determined by rigid sigmoidoscopy
- •Those with clinically diagnosed cT1-3, N0-2, M0 disease based on preoperative staging with pelvic magnetic resonance imaging, computed tomography, and/or positron emission tomography
- •Age of patients greater than or equal to 18 years
- •Those with American Society of Anesthesiologists (ASA) grading I-III,
- •Informed consent available
排除标准
- •Patients with locally advanced cancer not amenable to curative surgery (e.g. involved mesorectal fascia on pelvic magnetic imaging despite neoadjuvant chemoradiotherapy)
- •Those with locally advanced T4 cancer requiring en bloc multivisceral resection
- •Those with very low rectal tumor requiring abdominoperineal resection
- •Those with synchronous colorectal tumors requiring multisegment resection
- •Those undergoing emergency surgery
- •Those with previous history of abdominal surgery precluding the robotic or laparoscopic approach;
- •Those with severe cardiopulmonary disease rendering pneumoperitoneum hazardous
- •Those with psychiatric disease
- •Those who are pregnant
研究组 & 干预措施
Transanal Total Mesorectal Excision
For transanal total mesorectal excision, a two team approach will be adopted. One surgical team will be performing the abdominal phase dissection using standard laparoscopic approach, while the other will be simultaneously performing the transanal dissection and total mesorectal excision in a 'down-to-up' fashion using laparoscopic instruments.
干预措施: Transanal Total Mesorectal Excision (Procedure)
Robotic Total Mesorectal Excision
For robotic total mesorectal excision, a fully robotic approach will be adopted. Left-sided colonic mobilization, division of lymphovascular pedicle, and 'top-to-down' total mesorectal excision will be performed using the robotic platform.
干预措施: Robotic Total Mesorectal Excision (Procedure)
结局指标
主要结局
Incidence rate of achieving a composite of pathologic endpoint indicating adequate surgical resection
时间窗: Up to 1 month
Achieving a composite pathologic endpoint or a successful resection is defined as meeting all the following criteria: (1) complete total mesorectal excision, (2) clear circumferential resection margin (\>1 mm), and (3) clear distal resection margin (\> 1mm).
次要结局
- Urinary function at 3, 6, 9, and 12 months after surgery, measured by the International Prostate Symptom Score (IPSS)(Up to 12 months)
- Time to walk independently(Up to 1 month)
- Time to resume full solid diet(Up to 1 month)
- Morbidity within 30 days(Up to 1 month)
- Time to defecation(Up to 1 month)
- Rate of conversion(Up to 1 month)
- Pain scores on visual analog scale(Up to 1 month)
- Male sexual function at 3, 6, 9, and 12 months after surgery, measured by the International Index of Erectile Dysfunction - 5 (IIEF-5 questionnaire)(Up to 12 months)
- Length of hospital stay(Up to 1 month)
- Anal continence at 3, 6, 9, 12 months after surgery, measured by the Cleveland Clinic Incontinence Score (Wexner's Score)(Up to 12 months)
- Quality of life scores measured by Short Form 36 (SF-36) Health Survey at 3, 6, 9, 12 months after surgery(Up to 12 months)
- Quality of life scores measured by European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaires at 3, 6, 9, 12 months after surgery(Up to 12 months)
- Quality of life measured by European Organisation for Research and Treatment of Cancer (EORTC) QLQ-CR38 questionnaires at 3, 6, 9, 12 months after surgery(Up to 12 months)
- Direct/indirect medical costs and out-of-hospital economic costs(Up to 1 month)
研究者
Simon S. M. Ng
Professor
Chinese University of Hong Kong