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NCT02966483Completed

Transanal Versus Laparoscopic Total Mesorectal Excision For Rectal Cancer

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

Source: ClinicalTrials.gov · Last updated 16 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
1115 (actual)
First submitted
8 Nov 2016
Start date
1 Apr 2016
Primary completion date
30 Sept 2026
Lead sponsor
Sun Yat-sen University
NCT number
NCT02966483

What you commit to

  • Study type: Interventional
  • Participants enrolled: 1115
  • From 1 Apr 2016 to the primary completion date, 30 Sept 2026
  • 16 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • could not perform sphincter preservation surgery (requiring a Mile's procedure);
  • should take neoadjuvant therapy but refuse it;
  • concurrent or previous diagnosis of invasive cancer within 5 years;

Other illness

  • recurrent cancer;
  • emergent surgery with intestinal obstruction or perforation;
  • history of colorectal surgery;
  • history of inflammatory bowel disease;
  • history of mental disorder

Other

  • T4b tumor invading adjacent organs;
  • T1 tumors that can be locally resected
  • fecal incontinence;
  • with contraindications to general anaesthesia(ASA class 4 or 5);
  • pregnant or breast-feeding;

Who the study is looking for

  • 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

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (16)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Department of General Surgery, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences
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BeijingChinaUnknown status
Department of Gastrointestinal Surgery, The First Hospital of Jilin University
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ChangchunChinaUnknown status
The Third Xiangya Hospital of Central South University
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ChangshaChinaUnknown status
Xinqiao Hospital of Army Medical University
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ChongqingChinaUnknown status
Department of General Surgery, Daping Hospital, Army Medical university
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ChongqingChinaUnknown status
Department of colorectal surgery, the Sixth Affiliated Hospital, Sun Yat-Sen University
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GuangzhouChinaUnknown status
Nanfang Hospital
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GuangzhouChinaUnknown status
The First Affiliated Hospital of University of South China
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HengyangChinaUnknown status
Department of Gastrointestinal Surgery,The Affiliated Nanchong Central Hospital of North Sichuan Medical College
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NanchongChinaUnknown status
Department of Gastrointestinal Surgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University,
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ShanghaiChinaUnknown status
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
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ShanghaiChinaUnknown status
Department of Colorectal Surgery, Shengjing Hospital of China Medical University
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ShenyangChinaUnknown status
The First Affiliated Hospital of Xi'an Jiaotong University
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Xi’anChinaUnknown status
Department of gastrointestinal surgery, the Second People's Hospital of Yibin
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YibinChinaUnknown status
The Affiliated Hospital of Guangdong Medical University
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ZhanjiangChinaUnknown status
Affiliated Hospital of Zunyi Medical University
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ZunyiChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.