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Transanal Versus Laparoscopic Total Mesorectal Excision For Rectal Cancer

Primary Purpose

Rectal Neoplasms Malignant, Surgery

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
TaTME
LpTME
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Neoplasms Malignant focused on measuring Rectal cancer, Laparoscopic surgery, Total mesorectal excision, Transanal, Multicentre randomised clinical trial

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of General Surgery, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical SciencesRecruiting
  • Department of General Surgery, Daping Hospital, Army Medical universityRecruiting
  • Department of colorectal surgery, the Sixth Affiliated Hospital, Sun Yat-Sen UniversityRecruiting
  • Nanfang HospitalRecruiting
  • The Affiliated Hospital of Guangdong Medical UniversityRecruiting
  • Affiliated Hospital of Zunyi Medical UniversityRecruiting
  • The Third Xiangya Hospital of Central South UniversityRecruiting
  • The First Affiliated Hospital of University of South ChinaRecruiting
  • Department of Gastrointestinal Surgery, The First Hospital of Jilin UniversityRecruiting
  • Department of Colorectal Surgery, Shengjing Hospital of China Medical UniversityRecruiting
  • The First Affiliated Hospital of Xi'an Jiaotong UniversityRecruiting
  • Ruijin Hospital, Shanghai Jiao Tong University School of MedicineRecruiting
  • Department of Gastrointestinal Surgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University,Recruiting
  • Department of Gastrointestinal Surgery,The Affiliated Nanchong Central Hospital of North Sichuan Medical CollegeRecruiting
  • Department of gastrointestinal surgery, the Second People's Hospital of YibinRecruiting
  • XinQiao Hospital of Army Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Transanal Total Mesorectal Excision

Laparoscopic Total Mesorectal Excision

Arm Description

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.

The traditional laparoscopic TME (LpTME) was performed via standard laparoscopic techniques, including multiple trocars and conventional laparoscopic instruments.

Outcomes

Primary Outcome Measures

Disease-free survival
Disease-free survival
Overall survival
Overall survival

Secondary Outcome Measures

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

Full Information

First Posted
November 8, 2016
Last Updated
November 4, 2022
Sponsor
Sun Yat-sen University
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
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1. Study Identification

Unique Protocol Identification Number
NCT02966483
Brief Title
Transanal Versus Laparoscopic Total Mesorectal Excision For Rectal Cancer
Official Title
Transanal Versus Laparoscopic Total Mesorectal Excision For Mid And Low Rectal Cancer (TaLaR): A Multicentre Randomised Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 2016 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
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

4. Oversight

Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Neoplasms Malignant, Surgery
Keywords
Rectal cancer, Laparoscopic surgery, Total mesorectal excision, Transanal, Multicentre randomised clinical trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Transanal or Laparoscopic Total Mesorectal Excision treat rectal cancer
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1114 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transanal Total Mesorectal Excision
Arm Type
Experimental
Arm Description
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.
Arm Title
Laparoscopic Total Mesorectal Excision
Arm Type
Active Comparator
Arm Description
The traditional laparoscopic TME (LpTME) was performed via standard laparoscopic techniques, including multiple trocars and conventional laparoscopic instruments.
Intervention Type
Procedure
Intervention Name(s)
TaTME
Other Intervention Name(s)
Transanal TME
Intervention Description
Transanal Total Mesorectal Excision
Intervention Type
Procedure
Intervention Name(s)
LpTME
Other Intervention Name(s)
Laparoscopic TME
Intervention Description
Conventional Laparoscopic Total Mesorectal Excision
Primary Outcome Measure Information:
Title
Disease-free survival
Description
Disease-free survival
Time Frame
3 years
Title
Overall survival
Description
Overall survival
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Positive circumferential resection margin (CRM)
Description
Involved CRM (tumor cells <1mm)
Time Frame
3 years
Title
Overall survival
Description
Overall survival
Time Frame
10 years
Title
Mesorectal completeness
Description
The quality of the mesorectum or TME specimen (complete;nearly complete; incomplete)
Time Frame
3 years
Title
Number of retrieved lymph nodes
Description
Number of retrieved lymph nodes
Time Frame
3 years
Title
Morbidity rate
Description
Morbidity rate
Time Frame
1 years
Title
Mortality rate
Description
Mortality rate
Time Frame
1 years
Title
Anorectal function outcomes
Description
To evaluate defecating function with Wexner score
Time Frame
3 years
Title
Sexual functional outcomes
Description
To evaluate sexual function with IIEF(International Index of Erectile Function) questionnaire
Time Frame
3 years
Title
The patient's Quality of life: EORTC QLQ-30 questionnaire
Description
To evaluate quality of life with EORTC QLQ-30 questionnaire
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liang Kang, MD,PHD
Phone
008613602886833
Email
eonkang@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianping Wang, MD,PHD
Organizational Affiliation
the Sixth Affiliated Hospital, Sun Yat-Sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of General Surgery, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Xiao, MD, PhD
Phone
008613366036387
Email
XiaoY@pumch.cn
Facility Name
Department of General Surgery, Daping Hospital, Army Medical university
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weidong Tong, MD, PhD
Phone
008613500321218
Email
vdtong@163.com
Facility Name
Department of colorectal surgery, the Sixth Affiliated Hospital, Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liang Kang, MD, PhD
Phone
008613602886833
Email
eonkang@163.com
Facility Name
Nanfang Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510559
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanan Wang, MD.PhD
Facility Name
The Affiliated Hospital of Guangdong Medical University
City
Zhanjiang
State/Province
Guangdong
ZIP/Postal Code
524001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qingwen Xu, MD
Phone
008613600387083
Email
xuqwen@21cn.com
Facility Name
Affiliated Hospital of Zunyi Medical University
City
Zunyi
State/Province
Guizhou
ZIP/Postal Code
563003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ming Xie, MD
Phone
008615519202000
Email
2581303091@qq.com
Facility Name
The Third Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Zhang, MD,PhD
Facility Name
The First Affiliated Hospital of University of South China
City
Hengyang
State/Province
Hunan
ZIP/Postal Code
421001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Ouyang, MD
Phone
008613973426200
Email
1847039906@qq.com
Facility Name
Department of Gastrointestinal Surgery, The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Quan Wang, MD,PhD
Phone
008615843073207
Email
wangquanjdyy@163.com
Facility Name
Department of Colorectal Surgery, Shengjing Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Zhang, MD
Phone
008618940257919
Email
haojiubujian1203@sina.cn
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongchun Song, MD
Phone
008618991232549
Email
dr.songyongchun@qq.com
Facility Name
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bo Feng, MD,PhD
Phone
008613512103996
Email
fengbo2022@163.com
Facility Name
Department of Gastrointestinal Surgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University,
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qing Xu, MD, PhD
Phone
008613761002053
Email
renjixuqing@163.com
Facility Name
Department of Gastrointestinal Surgery,The Affiliated Nanchong Central Hospital of North Sichuan Medical College
City
Nanchong
State/Province
Sichuan
ZIP/Postal Code
637000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mingyang Ren, MD
Phone
008613890756
Email
2861746489@qq.com
Facility Name
Department of gastrointestinal surgery, the Second People's Hospital of Yibin
City
Yibin
State/Province
Sichuan
ZIP/Postal Code
644000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miao Wu, MD
Phone
008613990905852
Email
13990905852@163.com
Facility Name
XinQiao Hospital of Army Medical University
City
Chongqing
ZIP/Postal Code
400037
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dan Ma, MD,Phd
Phone
008615823555665
Email
1054727918@qq.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26220109
Citation
Chen WH, Kang L, Luo SL, Zhang XW, Huang Y, Liu ZH, Wang JP. Transanal total mesorectal excision assisted by single-port laparoscopic surgery for low rectal cancer. Tech Coloproctol. 2015 Sep;19(9):527-34. doi: 10.1007/s10151-015-1342-1. Epub 2015 Jul 29.
Results Reference
background
PubMed Identifier
26310534
Citation
Kang L, Chen WH, Luo SL, Luo YX, Liu ZH, Huang MJ, Wang JP. Transanal total mesorectal excision for rectal cancer: a preliminary report. Surg Endosc. 2016 Jun;30(6):2552-62. doi: 10.1007/s00464-015-4521-2. Epub 2015 Aug 27.
Results Reference
background
PubMed Identifier
31586244
Citation
Zeng Z, Luo S, Chen J, Cai Y, Zhang X, Kang L. Comparison of pathological outcomes after transanal versus laparoscopic total mesorectal excision: a prospective study using data from randomized control trial. Surg Endosc. 2020 Sep;34(9):3956-3962. doi: 10.1007/s00464-019-07167-1. Epub 2019 Oct 4.
Results Reference
derived

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Transanal Versus Laparoscopic Total Mesorectal Excision For Rectal Cancer

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