Robotic vs. TaTME Rectal Surgery (ROTA STUDY) Matched Cohort Trial for Mid to Low Rectal Cancer Surgery Evaluation Trial in the Hands of an Experienced Surgeon
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 330
- 试验地点
- 2
- 主要终点
- oncological outcomes RLAR vs TaTMe
研究概览
简要总结
Background Recent novel surgical techniques for resection of low rectal cancer have been introduced and these approaches have the potential to overcome anatomical limitations like obesity, narrow male pelvis and bulky and low tumours. Two of these procedures are robotic low anterior resection (RLAR) and transanal total mesorectal excision (TaTME).
Both approaches have distinct advantages and limitations however there have been no head to head trial comparing RLAR and TaTME for patients with mid to low rectal cancer undergoing surgery by experienced surgeons. Previous studies looking at the oncological outcomes of either TaTME or robotic TME included many centres where the surgeons were on a learning curve and hence the true oncological outcomes and clinical benefits cannot be measured accurately.
The primary objective of this pilot study is to conduct a multicentre prospective trial to investigate clinical outcomes, in particular disease free survival (DFS) in patients undergoing RLAR and TaTME. The additional goal is to investigate other efficacy measures, complications rates, recruitment feasibility and protocol refinement.
Method
This pilot study will be a prospective, observational, case-matched, two -cohort, multicentre designed to investigate the oncological and clinical outcomes of patients with mid-to-low, non-metastatic rectal cancer undergoing low anterior resection (LAR) using robot-assisted surgery ( RLAR), or transanal total mesorectal excision (TaTME).
The inclusion criteria consist of experienced surgeons defined as 60 prior procedures with RLAR or TaTME to meet the enrolment criteria for the RLAR and TaTME arm, respectively. Successful oncological and clinical outcomes are defined as circumferential resection margin (CRM) ≥1 mm with minimal postoperative morbidity (absence of Clavien-Dindo grade III-IV complications within 30 days after surgery). Local and distal recurrence rates with DFS over 3 years will be measured as primary outcome.
Secondary and exploratory endpoints will include length of hospital stay, intraoperative time, intraoperative blood loss, harvested lymph nodes, distal resection margin, incompleteness of mesorectum, CRM involvement, unplanned conversion rates, 30-days postoperative complications and overall recurrence rate. The Quality of life assessment questionnaires will be performed preoperatively, 6 months and 12 months after reversal of ileostomy.
Propensity score matching will be used to minimize bias from the nonrandomized treatment assignment. The RLAR and TaTME cohorts will be matched by propensity scores accounting for factors significantly associated with either undergoing robotic surgery or TaTME occurrence on logistic regression analysis.
Ethics and Dissemination The medical ethical committees of all the participating countries will be involved in approving the study protocol. Results of the primary and secondary end points will be submitted for publication in peer-reviewed journals.
详细描述
Introduction Colorectal cancer (CRC) is the fourth most common malignant disease with over 1 million new cases each year worldwide (1) The outcome of surgery for rectal cancer has improved substantially during the past two decades due to TME, which involves complete removal of the mesorectum with preservation of the pelvic autonomic nerves. Local recurrence rate of rectal cancer has fallen sharply because radially spread cancer cells in the mesorectum are removed by complete resection of this tissue.(2)(3)(4) Minimally invasive surgery (MIS) is slowly taking over as the preferred operative approach for colorectal diseases. Recently published randomized clinical trials (RCTs), such as COLOR II, COREAN and CLASICC, have shown better results for laparoscopic total mesorectal excision (in terms of short-term and long-term outcomes), when compared with open TME(5)(6)(7) However the utility of laparoscopic TME is limited in patients with low rectal cancer, who require surgeons with experience in ultra-low sphincter-saving laparoscopic surgery, which has a high risk of leaving a positive circumferential resection margin (CRM). In addition, narrow pelvic anatomy; male sex and high body mass index (BMI) are also unfavourable patient characteristics for a laparoscopic approach
The need to overcome these challenges has motivated surgeons to adopt alternative techniques. The two more recent procedures that have been introduced to surgical management of rectal cancer are robotic low anterior resection (RLAR) and Transanal Total Mesorectal Excision (TaTME). These two new procedures have the potential to overcome anatomical limitations like obesity, narrow male pelvis and bulky and low tumours to improve surgical treatment and thereby potentially oncological outcomes.
TaTME combines the TAMIS ( transanal minimally invasive surgery ) and trans-abdominal approaches in order to achieve TME.Transanal TME (TaTME) typically starts with the rectal resection and progresses to the splenic flexure/sigmoid colon mobilization in a "bottom-up" manner (8). A single-incision laparoscopic surgery port is introduced into the anal canal to gain endoscopic access to the rectum, pneumorectum is established, A purse-string suture is applied below the tumor, and this ensures an adequate oncological distal margin (9). Transanal excision is subsequently performed using laparoscopic instruments Rectal distension with CO2 combined with magnified optics permits excellent visualization of tissue planes. Easier access to the low rectum aid the surgeon with better quality TME and precise selection of the distal resection margin under direct visualization helps ensure an adequate margin. TaTME may potentially aid to a safer anastomosis by avoiding the multiple stapler firings often required in the laparoscopic approach and may result in higher rates of sphincter preserving surgery.
Robotic approach has been subject to much interest in recent years from its potential learning benefits to the operating surgeon and clinical benefits to the patients. Some of the clinical benefits include shorter hospital stay and improved functional outcomes compared to laparoscopic surgery (10) The other advantages provided by the robotic platform hold the potential to provide improved clinical outcomes, (11)(12) (13).
Both of the new procedures have been compared retrospectively to open and conventional laparoscopic surgery in various trials, which show that these methods are safe and feasible (9)(14). However, data on direct comparison of these two techniques are still lacking.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •• Participant is willing and able to give informed consent for participation in the trial.
- •Male or Female, aged 18 years or above.
- •Undergoing TME surgery for rectal cancer after MDT discussion.
- •Participant has no contra-indication to pelvic radiotherapy at the time of enrolment.
- •In the Investigator's opinion, is able and willing to comply with all trial requirements.
- •Tumour distance from anal verge - 12 cm or less
- •Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the trial.
排除标准
- •• Female participant who is pregnant, lactating or planning pregnancy during the course of the trial.
- •Participant with life expectancy of less than 6 months.
- •Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
结局指标
主要结局
oncological outcomes RLAR vs TaTMe
时间窗: 3 year disease free survival
The primary aim of the study is to compare the 3 year disease free survival between RLAR and TaTME in the hands of an experienced surgeon
次要结局
未报告次要终点
研究者
Issam al-Najami
principal investigator. phd. associate professor
Odense University Hospital
