Transanal Versus Laparoscopic Total Mesorectal Excision For Rectal Cancer

November 4, 2022 updated by: Yanhong Deng, Sun Yat-sen University

Transanal Versus Laparoscopic Total Mesorectal Excision For Mid And Low Rectal Cancer (TaLaR): A Multicentre Randomised Clinical Trial

Laparoscopic surgery for rectal cancer has been successfully proven to be a non-inferior alternative regarding resection quality, and oncological outcomes of patients as compared to open surgery in mangy clinical trails. Moreover, laparoscopic surgery is advantageous over open surgery with regard to operative invasiveness, patient's recovery, and wound related complications. Thus, laparoscopic surgery has gained great popularity over the past decades. However, specifically for mid and low rectal cancer, laparoscopic surgery is technically demanding, which sometimes leads to high morbidity and unsatisfactory resection quality, especially in challenging cases such as bulky mesorectum, enlarged prostate, irradiated pelvis, etc. Under this circumstance, transanal total mesorectal excision (TaTME) , the so called "down-to-up" alternative, has emerged as a promising solution to these problems in recent years and more and more small studies have proven the feasibility and advantages of this technique, making it become a hot topic among both literature and conferences. However, TaTME is still at early birth, higher-level evidences, either multicentric, or comparative study with conventional surgery is strikingly lacking. Thus the investigators conduct this multicentre randomised clinical trial, comparing transanal TME versus laparoscopic TME for mid and low rectal cancer, aiming to prove the hypothesis that TaTME may achieve better resection quality and result in non-inferior oncological outcome, as well as short term operative morbidity and mortality.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Background:In recent years, transanal mesorectal excision (TaTME) has emerged as a promising surgical alternative for rectal cancer, especially for mid and low rectal cancer. Theoretically, TaTME holds the potential advantage of providing better access to mobilize the distal rectum, and thus could achieve better pathologic outcomes, such as lower involved circumferential margin (CRM) and incomplete resected mesorectum, which could translate into better oncological outcome for the patients in the long term. However, until now, the feasibility and the non-inferiority (compared with laparoscopic total mesorectal excision, LpTME) of this technique has only been validated in studies with limitations of small sample size, retrospective nature.

Study Objective:This study aims to evaluate the TaTME technique compared with conventional laparoscopic rectal surgery, focusing on resection quality, as well as long-term survival results.

Study design This study is a prospective, multi-center, randomized, open-label, parallel group trial. The randomisation ratio of TaTME over LpTME will be 1:1. A central electronic data capture (EDC) system will be utilized for randomization, electronic CRF and data collection. All comparative analyses will be conducted on an "intention to treat" basis.

Sample size: Sample-size calculation of this trial based on 3-year DFS and 5-year OS; but the sample size according to 5-year OS was larger than that based on 3-year DFS. The expected 5-year OS among clinical stage I-III rectal cancer patients treated with laTME was 77·4%. Allowing a difference of 10% as the non-inferiority margin, 910 patients would be required to sufficiently declare taTME noninferior to laTME in 5-year OS based on a log-rank test with an α error of 2·5% (in a two-sided test) and power of 80%. Assuming a dropout rate of 20%, a total of 1114 patients were planned to enroll for this trial.

Study Endpoints:The primary end point of this study is 3-year disease-free survival (DFS) rate and a 5-year overall survival (OS) rate. Secondary endpoints include: 1) resection quality, mainly including circumferential involvement rate, and completeness of mesorectum. Resected specimen was pathologically processed and assessed at each center by trained and qualified pathologists independently.2)short term operative results such as morbidity and mortality, etc.; 3) long term oncological outcome such as local recurrence, and overall survival. Besides, functional outcome and quality of life are also evaluated.

Study Type

Interventional

Enrollment (Anticipated)

1114

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Chongqing, China, 400037
        • Recruiting
        • Xinqiao Hospital of Army Medical University
        • Contact:
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Department of General Surgery, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences
        • Contact:
          • Yi Xiao, MD, PhD
          • Phone Number: 008613366036387
          • Email: XiaoY@pumch.cn
    • Chongqing
      • Chongqing, Chongqing, China, 400042
        • Recruiting
        • Department of General Surgery, Daping Hospital, Army Medical university
        • Contact:
          • Weidong Tong, MD, PhD
          • Phone Number: 008613500321218
          • Email: vdtong@163.com
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • Department of colorectal surgery, the Sixth Affiliated Hospital, Sun Yat-Sen University
      • Guangzhou, Guangdong, China, 510559
        • Recruiting
        • Nanfang Hospital
        • Contact:
          • Yanan Wang, MD.PhD
      • Zhanjiang, Guangdong, China, 524001
        • Recruiting
        • The Affiliated Hospital of Guangdong Medical University
        • Contact:
    • Guizhou
      • Zunyi, Guizhou, China, 563003
        • Recruiting
        • Affiliated Hospital of Zunyi Medical University
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410013
        • Recruiting
        • The Third Xiangya Hospital of Central South University
        • Contact:
          • Yi Zhang, MD,PhD
      • Hengyang, Hunan, China, 421001
        • Recruiting
        • The First Affiliated Hospital of University of South China
        • Contact:
    • Jilin
      • Changchun, Jilin, China, 130021
        • Recruiting
        • Department of Gastrointestinal Surgery, The First Hospital of Jilin University
        • Contact:
    • Liaoning
      • Shenyang, Liaoning, China, 110004
        • Recruiting
        • Department of Colorectal Surgery, Shengjing Hospital of China Medical University
        • Contact:
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Recruiting
        • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
        • Contact:
      • Shanghai, Shanghai, China, 200127
        • Recruiting
        • Department of Gastrointestinal Surgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University,
        • Contact:
    • Sichuan
      • Nanchong, Sichuan, China, 637000
        • Recruiting
        • Department of Gastrointestinal Surgery，The Affiliated Nanchong Central Hospital of North Sichuan Medical College
        • Contact:
      • Yibin, Sichuan, China, 644000
        • Recruiting
        • Department of gastrointestinal surgery, the Second People's Hospital of Yibin
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

histologically proven rectal adenocarcinoma;

tumor located below the level of peritoneal reflection ;

diagnosis of rectal cancer amenable to curative surgery;

no evidence of distant metastases;

preoperative tumor stage within III;

no threaten mesorectal fascia (MRF)after neoadjuvant therapy;

no contraindication to laparoscopic surgery;

without history of other malignancies;

Written informed consent

Exclusion Criteria:

could not perform sphincter preservation surgery (requiring a Mile's procedure);

T4b tumor invading adjacent organs;

T1 tumors that can be locally resected

should take neoadjuvant therapy but refuse it;

recurrent cancer;

concurrent or previous diagnosis of invasive cancer within 5 years;

emergent surgery with intestinal obstruction or perforation;

history of colorectal surgery;

fecal incontinence;

history of inflammatory bowel disease;

with contraindications to general anaesthesia(ASA class 4 or 5);

pregnant or breast-feeding;

history of mental disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transanal Total Mesorectal Excision
The rectum is mobilized and resected transanally (from bottom to up) according to TME principles, via transanal platform (either rigid or flexible platform).An ideal TaTME is defined as the extraperitoneal portion of the rectum being mobilized from below.
Procedure: TaTME
Transanal Total Mesorectal Excision
Other Names:
  • Transanal TME
Active Comparator: Laparoscopic Total Mesorectal Excision
The traditional laparoscopic TME (LpTME) was performed via standard laparoscopic techniques, including multiple trocars and conventional laparoscopic instruments.
Procedure: LpTME
Conventional Laparoscopic Total Mesorectal Excision
Other Names:
  • Laparoscopic TME

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 5 years
Overall survival
5 years
Disease-free survival
Time Frame: 3 years
Disease-free survival
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive circumferential resection margin (CRM)
Time Frame: 3 years
Involved CRM (tumor cells <1mm)
3 years
Overall survival
Time Frame: 10 years
Overall survival
10 years
Mesorectal completeness
Time Frame: 3 years
The quality of the mesorectum or TME specimen (complete;nearly complete; incomplete)
3 years
Number of retrieved lymph nodes
Time Frame: 3 years
Number of retrieved lymph nodes
3 years
Morbidity rate
Time Frame: 1 years
Morbidity rate
1 years
Mortality rate
Time Frame: 1 years
Mortality rate
1 years
Anorectal function outcomes
Time Frame: 3 years
To evaluate defecating function with Wexner score
3 years
Sexual functional outcomes
Time Frame: 3 years
To evaluate sexual function with IIEF(International Index of Erectile Function) questionnaire
3 years
The patient's Quality of life: EORTC QLQ-30 questionnaire
Time Frame: 3 years
To evaluate quality of life with EORTC QLQ-30 questionnaire
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Collaborators

Peking Union Medical College Hospital
RenJi Hospital
Shengjing Hospital
First Affiliated Hospital Xi'an Jiaotong University
Nanfang Hospital of Southern Medical University
Ruijin Hospital
The Third Xiangya Hospital of Central South University
The First Hospital of Jilin University
The First Affiliated Hospital of University of South China
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
The Affiliated Hospital of Guangdong Medical College
Zunyi Medical College
The Second People's Hospital of Yibin
Nanchong Central Hospital
Xinqiao Hospital

Investigators

  • Principal Investigator: Jianping Wang, MD,PHD, The Sixth Affiliated Hospital, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Anticipated)

July 1, 2025

Study Completion (Anticipated)

July 1, 2025

Study Registration Dates

First Submitted

November 8, 2016

First Submitted That Met QC Criteria

November 16, 2016

First Posted (Estimate)

November 17, 2016

Study Record Updates

Last Update Posted (Actual)

November 7, 2022

Last Update Submitted That Met QC Criteria

November 4, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYSU-RECTAl-2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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