NCT02966483

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,114

participants targeted

Target at P75+ for not_applicable

Timeline
2mo left

Started Apr 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

16 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Apr 2016Jul 2026

Study Start

First participant enrolled

April 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 17, 2016

Completed
9.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

January 17, 2025

Status Verified

January 1, 2025

Enrollment Period

10.3 years

First QC Date

November 8, 2016

Last Update Submit

January 15, 2025

Conditions

Rectal Neoplasms MalignantSurgery

Keywords

Rectal cancerLaparoscopic surgeryTotal mesorectal excisionTransanalMulticentre randomised clinical trial

Outcome Measures

Primary Outcomes (2)

  • Disease-free survival

    Disease-free survival

    3 years

  • Overall survival

    Overall survival

    5 years

Secondary Outcomes (9)

  • Positive circumferential resection margin (CRM)

    3 years

  • Overall survival

    10 years

  • Mesorectal completeness

    3 years

  • Number of retrieved lymph nodes

    3 years

  • Morbidity rate

    1 years

  • +4 more secondary outcomes

Study Arms (2)

Transanal Total Mesorectal Excision

EXPERIMENTAL

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

Laparoscopic Total Mesorectal Excision

ACTIVE COMPARATOR

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

Procedure: LpTME

Interventions

TaTMEPROCEDURE

Transanal Total Mesorectal Excision

Also known as: Transanal TME
Transanal Total Mesorectal Excision
LpTMEPROCEDURE

Conventional Laparoscopic Total Mesorectal Excision

Also known as: Laparoscopic TME
Laparoscopic Total Mesorectal Excision

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Department of General Surgery, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100730, China

RECRUITING

Department of General Surgery, Daping Hospital, Army Medical university

Chongqing, Chongqing Municipality, 400042, China

RECRUITING

Department of colorectal surgery, the Sixth Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 510000, China

COMPLETED

Nanfang Hospital

Guangzhou, Guangdong, 510559, China

RECRUITING

The Affiliated Hospital of Guangdong Medical University

Zhanjiang, Guangdong, 524001, China

RECRUITING

Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, 563003, China

RECRUITING

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

RECRUITING

The First Affiliated Hospital of University of South China

Hengyang, Hunan, 421001, China

RECRUITING

Department of Gastrointestinal Surgery, The First Hospital of Jilin University

Changchun, Jilin, 130021, China

RECRUITING

Department of Colorectal Surgery, Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

RECRUITING

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Department of Gastrointestinal Surgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University,

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

Department of Gastrointestinal Surgery，The Affiliated Nanchong Central Hospital of North Sichuan Medical College

Nanchong, Sichuan, 637000, China

RECRUITING

Department of gastrointestinal surgery, the Second People's Hospital of Yibin

Yibin, Sichuan, 644000, China

RECRUITING

XinQiao Hospital of Army Medical University

Chongqing, 400037, China

RECRUITING

Related Publications (5)

  • 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.

    PMID: 26220109BACKGROUND

  • 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.

    PMID: 26310534BACKGROUND

  • Zeng Z, Luo S, Zhang H, Wu M, Ma D, Wang Q, Xie M, Xu Q, Ouyang J, Xiao Y, Song Y, Feng B, Xu Q, Wang Y, Zhang Y, Shi L, Ling L, Zhang X, Huang L, Yang Z, Peng J, Wu X, Ren D, Huang M, Lan P, Wang J, Tong W, Ren M, Liu H, Kang L; Chinese Transanal Endoscopic Surgery Collaborative (CTESC) Group. Transanal vs Laparoscopic Total Mesorectal Excision and 3-Year Disease-Free Survival in Rectal Cancer: The TaLaR Randomized Clinical Trial. JAMA. 2025 Mar 4;333(9):774-783. doi: 10.1001/jama.2024.24276.

    PMID: 39847361DERIVED

  • Chen M, Ye F, Huang P, Liang Z, Liu H, Zheng X, Li W, Luo S, Kang L, Huang L. Inflammatory stress response after transanal vs laparoscopic total mesorectal excision: a cohort study based on the TaLaR trial. Int J Surg. 2024 Jan 1;110(1):151-158. doi: 10.1097/JS9.0000000000000838.

    PMID: 37916926DERIVED

  • 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.

    PMID: 31586244DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Jianping Wang, MD,PHD

    The Sixth Affiliated Hospital, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Liang Kang, MD,PHD

CONTACT

008613602886833eonkang@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Transanal or Laparoscopic Total Mesorectal Excision treat rectal cancer
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 8, 2016

First Posted

November 17, 2016

Study Start

April 1, 2016

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

January 17, 2025

Record last verified: 2025-01

Locations

CN(16)