Transanal Versus Laparoscopic Total Mesorectal Excision for Rectal Cancer

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-sen University

About this trial

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 criteria

Qualifiers

None

Disqualifiers

None

Trial design

Treatments tested in this trial

  • TaTME
  • LpTME

Treatment groups

1,114 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Sun Yat-sen University

Lead sponsor

Peking Union Medical College Hospital

Collaborator

The First Hospital of Jilin University

Collaborator

RenJi Hospital

Collaborator

Shengjing Hospital

Collaborator

The Second People's Hospital of Yibin

Collaborator

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Collaborator

Nanchong Central Hospital

Collaborator

Zunyi Medical College

Collaborator

The First Affiliated Hospital of University of South China

Collaborator

Xinqiao Hospital

Collaborator

Nanfang Hospital, Southern Medical University

Collaborator

First Affiliated Hospital Xi'an Jiaotong University

Collaborator

Ruijin Hospital

Collaborator

Affiliated Hospital of Guangdong Medical University

Collaborator

The Third Xiangya Hospital of Central South University

Collaborator