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Transanal Versus Laparoscopic Total Mesorectal Excision For Rectal Cancer

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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

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.

Condition or disease Intervention/treatment Phase
Rectal Neoplasms Malignant Surgery Procedure: TaTME Procedure: LpTME Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1114 participants
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
Official Title: Transanal Versus Laparoscopic Total Mesorectal Excision For Mid And Low Rectal Cancer (TaLaR): A Multicentre Randomised Clinical Trial
Actual Study Start Date : April 2016
Estimated Primary Completion Date : July 2025
Estimated Study Completion Date : July 2025

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 Name: 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 Name: Laparoscopic TME




Primary Outcome Measures :
  1. Disease-free survival [ Time Frame: 3 years ]
    Disease-free survival

  2. Overall survival [ Time Frame: 5 years ]
    Overall survival


Secondary Outcome Measures :
  1. Positive circumferential resection margin (CRM) [ Time Frame: 3 years ]
    Involved CRM (tumor cells <1mm)

  2. Overall survival [ Time Frame: 10 years ]
    Overall survival

  3. Mesorectal completeness [ Time Frame: 3 years ]
    The quality of the mesorectum or TME specimen (complete;nearly complete; incomplete)

  4. Number of retrieved lymph nodes [ Time Frame: 3 years ]
    Number of retrieved lymph nodes

  5. Morbidity rate [ Time Frame: 1 years ]
    Morbidity rate

  6. Mortality rate [ Time Frame: 1 years ]
    Mortality rate

  7. Anorectal function outcomes [ Time Frame: 3 years ]
    To evaluate defecating function with Wexner score

  8. Sexual functional outcomes [ Time Frame: 3 years ]
    To evaluate sexual function with IIEF(International Index of Erectile Function) questionnaire

  9. The patient's Quality of life: EORTC QLQ-30 questionnaire [ Time Frame: 3 years ]
    To evaluate quality of life with EORTC QLQ-30 questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02966483


Contacts
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Contact: Liang Kang, MD,PHD 008613602886833 eonkang@163.com

Locations
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China, Beijing
Department of General Surgery, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences Recruiting
Beijing, Beijing, China, 100730
Contact: Yi Xiao, MD, PhD    008613366036387    XiaoY@pumch.cn   
China, Chongqing
Department of General Surgery, Daping Hospital, Army Medical university Recruiting
Chongqing, Chongqing, China, 400042
Contact: Weidong Tong, MD, PhD    008613500321218    vdtong@163.com   
China, Guangdong
Department of colorectal surgery, the Sixth Affiliated Hospital, Sun Yat-Sen University Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Liang Kang, MD, PhD    008613602886833    eonkang@163.com   
Nanfang Hospital Recruiting
Guangzhou, Guangdong, China, 510559
Contact: Yanan Wang, MD.PhD         
The Affiliated Hospital of Guangdong Medical University Recruiting
Zhanjiang, Guangdong, China, 524001
Contact: Qingwen Xu, MD    008613600387083    xuqwen@21cn.com   
China, Guizhou
Affiliated Hospital of Zunyi Medical University Recruiting
Zunyi, Guizhou, China, 563003
Contact: Ming Xie, MD    008615519202000    2581303091@qq.com   
China, Hunan
The Third Xiangya Hospital of Central South University Recruiting
Changsha, Hunan, China, 410013
Contact: Yi Zhang, MD,PhD         
The First Affiliated Hospital of University of South China Recruiting
Hengyang, Hunan, China, 421001
Contact: Jun Ouyang, MD    008613973426200    1847039906@qq.com   
China, Jilin
Department of Gastrointestinal Surgery, The First Hospital of Jilin University Recruiting
Changchun, Jilin, China, 130021
Contact: Quan Wang, MD,PhD    008615843073207    wangquanjdyy@163.com   
China, Liaoning
Department of Colorectal Surgery, Shengjing Hospital of China Medical University Recruiting
Shenyang, Liaoning, China, 110004
Contact: Hong Zhang, MD    008618940257919    haojiubujian1203@sina.cn   
China, Shaanxi
The First Affiliated Hospital of Xi'an Jiaotong University Recruiting
Xi'an, Shaanxi, China, 710061
Contact: Yongchun Song, MD    008618991232549    dr.songyongchun@qq.com   
China, Shanghai
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200025
Contact: Bo Feng, MD,PhD    008613512103996    fengbo2022@163.com   
Department of Gastrointestinal Surgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Recruiting
Shanghai, Shanghai, China, 200127
Contact: Qing Xu, MD, PhD    008613761002053    renjixuqing@163.com   
China, Sichuan
Department of Gastrointestinal Surgery,The Affiliated Nanchong Central Hospital of North Sichuan Medical College Recruiting
Nanchong, Sichuan, China, 637000
Contact: Mingyang Ren, MD    008613890756    2861746489@qq.com   
Department of gastrointestinal surgery, the Second People's Hospital of Yibin Recruiting
Yibin, Sichuan, China, 644000
Contact: Miao Wu, MD    008613990905852    13990905852@163.com   
China
XinQiao Hospital of Army Medical University Recruiting
Chongqing, China, 400037
Contact: Dan Ma, MD,Phd    008615823555665    1054727918@qq.com   
Sponsors and Collaborators
Sun Yat-sen University
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
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Principal Investigator: Jianping Wang, MD,PHD the Sixth Affiliated Hospital, Sun Yat-Sen University
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yanhong Deng, MD, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02966483    
Other Study ID Numbers: SYSU-RECTAl-2016
First Posted: November 17, 2016    Key Record Dates
Last Update Posted: November 7, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yanhong Deng, Sun Yat-sen University:
Rectal cancer
Laparoscopic surgery
Total mesorectal excision
Transanal
Multicentre randomised clinical trial
Additional relevant MeSH terms:
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Rectal Neoplasms
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases