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
- Diseases
- Colorectal cancer
- 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
Sites (16)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of General Surgery, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Department of Gastrointestinal Surgery, The First Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| The Third Xiangya Hospital of Central South University Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Xinqiao Hospital of Army Medical University Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Department of General Surgery, Daping Hospital, Army Medical university Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Department of colorectal surgery, the Sixth Affiliated Hospital, Sun Yat-Sen University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Nanfang Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The First Affiliated Hospital of University of South China Coordinator of this site? Confirm its status | Hengyang | China | Unknown status |
| Department of Gastrointestinal Surgery,The Affiliated Nanchong Central Hospital of North Sichuan Medical College Coordinator of this site? Confirm its status | Nanchong | China | Unknown status |
| Department of Gastrointestinal Surgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Department of Colorectal Surgery, Shengjing Hospital of China Medical University Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
| The First Affiliated Hospital of Xi'an Jiaotong University Coordinator of this site? Confirm its status | Xi’an | China | Unknown status |
| Department of gastrointestinal surgery, the Second People's Hospital of Yibin Coordinator of this site? Confirm its status | Yibin | China | Unknown status |
| The Affiliated Hospital of Guangdong Medical University Coordinator of this site? Confirm its status | Zhanjiang | China | Unknown status |
| Affiliated Hospital of Zunyi Medical University Coordinator of this site? Confirm its status | Zunyi | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.