Transanal Versus Laparoscopic Total Mesorectal Excision for Rectal Cancer

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.

Conditions

• Rectal Neoplasms Malignant
• Surgery

Interventions

PROCEDURE

TaTME

Transanal Total Mesorectal Excision

PROCEDURE

LpTME

Conventional Laparoscopic Total Mesorectal Excision

Sponsors & Collaborators

• Peking Union Medical College Hospital

  collaborator OTHER

• The First Hospital of Jilin University

  collaborator OTHER

• RenJi Hospital

  collaborator OTHER

• Shengjing Hospital

  collaborator OTHER

• The Second People's Hospital of Yibin

  collaborator OTHER

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

  collaborator OTHER

• Nanchong Central Hospital

  collaborator OTHER_GOV

• Zunyi Medical College

  collaborator OTHER

• The First Affiliated Hospital of University of South China

  collaborator OTHER

• Xinqiao Hospital

  collaborator UNKNOWN

• Nanfang Hospital, Southern Medical University

  collaborator OTHER

• First Affiliated Hospital Xi'an Jiaotong University

  collaborator OTHER

• Ruijin Hospital

  collaborator OTHER

• Affiliated Hospital of Guangdong Medical University

  collaborator OTHER

• The Third Xiangya Hospital of Central South University

  collaborator OTHER

• Sun Yat-sen University

  lead OTHER

Principal Investigators

• Jianping Wang, MD,PHD · The Sixth Affiliated Hospital, Sun Yat-sen University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-04-30

Primary Completion

2026-07-31

Completion

2026-07-31

Countries

• China

Study Locations