RecruitingNot ApplicableNCT02966483

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


Sponsor

Sun Yat-sen University

Enrollment

1,114 participants

Start Date

Apr 1, 2016

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two surgical approaches for removing rectal cancer: one done through the abdomen using a camera (laparoscopic), and one done through the anus (transanal), to see which produces better outcomes. **You may be eligible if...** - You have been confirmed to have rectal cancer (adenocarcinoma) by a biopsy - Your tumor is in the lower part of the rectum (below the peritoneal reflection) - Surgery with the goal of curing the cancer is possible - The cancer has not spread to distant parts of the body - The cancer is stage III or below before treatment - The tissue margin around the tumor is not threatened (or has improved after pre-surgery treatment) - You have no history of other cancers - You have provided written consent **You may NOT be eligible if...** - The surgery cannot preserve your sphincter (the muscle that controls bowel movements) - Laparoscopic surgery is not safe for you Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURETaTME

Transanal Total Mesorectal Excision

PROCEDURELpTME

Conventional Laparoscopic Total Mesorectal Excision


Locations(16)

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

Beijing, Beijing Municipality, China

Department of General Surgery, Daping Hospital, Army Medical university

Chongqing, Chongqing Municipality, China

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

Guangzhou, Guangdong, China

Nanfang Hospital

Guangzhou, Guangdong, China

The Affiliated Hospital of Guangdong Medical University

Zhanjiang, Guangdong, China

Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, China

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

The First Affiliated Hospital of University of South China

Hengyang, Hunan, China

Department of Gastrointestinal Surgery, The First Hospital of Jilin University

Changchun, Jilin, China

Department of Colorectal Surgery, Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

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

Shanghai, Shanghai Municipality, China

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

Nanchong, Sichuan, China

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

Yibin, Sichuan, China

XinQiao Hospital of Army Medical University

Chongqing, China

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NCT02966483


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