This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Transanal Versus Laparoscopic Total Mesorectal Excision For Rectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02966483
Recruitment Status : Recruiting
First Posted : November 17, 2016
Last Update Posted : November 7, 2022
Sponsor:
Collaborators:
Peking Union Medical College Hospital
The First Hospital of Jilin University
RenJi Hospital
Shengjing Hospital
The Second People's Hospital of Yibin
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Nanchong Central Hospital
Zunyi Medical College
The First Affiliated Hospital of University of South China
Xinqiao Hospital
Nanfang Hospital, Southern Medical University
First Affiliated Hospital Xi'an Jiaotong University
Ruijin Hospital
Affiliated Hospital of Guangdong Medical University
The Third Xiangya Hospital of Central South University
Information provided by (Responsible Party):
Yanhong Deng, Sun Yat-sen University

Tracking Information
First Submitted Date  ICMJE November 8, 2016
First Posted Date  ICMJE November 17, 2016
Last Update Posted Date November 7, 2022
Actual Study Start Date  ICMJE April 2016
Estimated Primary Completion Date July 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 27, 2021)
  • Disease-free survival [ Time Frame: 3 years ]
    Disease-free survival
  • Overall survival [ Time Frame: 5 years ]
    Overall survival
Original Primary Outcome Measures  ICMJE
 (submitted: November 16, 2016)
Disease-free survival [ Time Frame: 3 years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 27, 2021)
  • Positive circumferential resection margin (CRM) [ Time Frame: 3 years ]
    Involved CRM (tumor cells <1mm)
  • Overall survival [ Time Frame: 10 years ]
    Overall survival
  • Mesorectal completeness [ Time Frame: 3 years ]
    The quality of the mesorectum or TME specimen (complete;nearly complete; incomplete)
  • Number of retrieved lymph nodes [ Time Frame: 3 years ]
    Number of retrieved lymph nodes
  • Morbidity rate [ Time Frame: 1 years ]
    Morbidity rate
  • Mortality rate [ Time Frame: 1 years ]
    Mortality rate
  • Anorectal function outcomes [ Time Frame: 3 years ]
    To evaluate defecating function with Wexner score
  • Sexual functional outcomes [ Time Frame: 3 years ]
    To evaluate sexual function with IIEF(International Index of Erectile Function) questionnaire
  • The patient's Quality of life: EORTC QLQ-30 questionnaire [ Time Frame: 3 years ]
    To evaluate quality of life with EORTC QLQ-30 questionnaire
Original Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2016)
  • Overall survival [ Time Frame: 5 years ]
  • Positive circumferential resection margin (CRM) [ Time Frame: 3 years ]
    Involved CRM (tumor cells <1mm)
  • Mesorectal completeness [ Time Frame: 3 years ]
    The quality of the mesorectum or TME specimen (complete;nearly complete;imcomplete)
  • Number of retrieved lymph nodes [ Time Frame: 3 years ]
  • Morbidity rate [ Time Frame: 1 years ]
  • Mortality rate [ Time Frame: 1 years ]
  • Anorectal function outcomes [ Time Frame: 3 years ]
    To evaluate defecating function with Wexner score
  • Sexual functional outcomes [ Time Frame: 3 years ]
    To evaluate sexual function with IIEF(International Index of Erectile Function) questionnaire
  • Quality of life [ Time Frame: 3 years ]
    To evaluate quality of life with EORTC QLQ-30 questionnaire
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transanal Versus Laparoscopic Total Mesorectal Excision For Rectal Cancer
Official Title  ICMJE Transanal Versus Laparoscopic Total Mesorectal Excision For Mid And Low Rectal Cancer (TaLaR): A Multicentre Randomised Clinical Trial
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Transanal or Laparoscopic Total Mesorectal Excision treat rectal cancer
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Rectal Neoplasms Malignant
  • Surgery
Intervention  ICMJE
  • Procedure: TaTME
    Transanal Total Mesorectal Excision
    Other Name: Transanal TME
  • Procedure: LpTME
    Conventional Laparoscopic Total Mesorectal Excision
    Other Name: Laparoscopic TME
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: TaTME
  • Active Comparator: Laparoscopic Total Mesorectal Excision
    The traditional laparoscopic TME (LpTME) was performed via standard laparoscopic techniques, including multiple trocars and conventional laparoscopic instruments.
    Intervention: Procedure: LpTME
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 16, 2016)
1114
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2025
Estimated Primary Completion Date July 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Liang Kang, MD,PHD 008613602886833 eonkang@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02966483
Other Study ID Numbers  ICMJE SYSU-RECTAl-2016
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Yanhong Deng, Sun Yat-sen University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Sun Yat-sen University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Peking Union Medical College Hospital
  • The First Hospital of Jilin University
  • RenJi Hospital
  • Shengjing Hospital
  • The Second People's Hospital of Yibin
  • Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
  • Nanchong Central Hospital
  • Zunyi Medical College
  • The First Affiliated Hospital of University of South China
  • Xinqiao Hospital
  • Nanfang Hospital, Southern Medical University
  • First Affiliated Hospital Xi'an Jiaotong University
  • Ruijin Hospital
  • Affiliated Hospital of Guangdong Medical University
  • The Third Xiangya Hospital of Central South University
Investigators  ICMJE
Principal Investigator: Jianping Wang, MD,PHD The Sixth Affiliated Hospital, Sun Yat-sen University
PRS Account Sun Yat-sen University
Verification Date November 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP