Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT02966483

Transanal Versus Laparoscopic Total Mesorectal Excision for Rectal Cancer

Led by Sun Yat-sen University · Updated on 2025-01-17

1114

Participants Needed

16

Research Sites

534 weeks

Total Duration

On this page

Sponsors

S

Sun Yat-sen University

Lead Sponsor

P

Peking Union Medical College Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Transanal Versus Laparoscopic Total Mesorectal Excision for Rectal Cancer

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically proven rectal adenocarcinoma
  • Tumor located below the level of peritoneal reflection
  • Diagnosis of rectal cancer suitable for curative surgery
  • No evidence of distant metastases
  • Preoperative tumor stage within III
  • No threatened mesorectal fascia after neoadjuvant therapy
  • No contraindication to laparoscopic surgery
  • No history of other malignancies
  • Written informed consent
Not Eligible

You will not qualify if you...

  • Unable to perform sphincter preservation surgery (requiring a Mile's procedure)
  • T4b tumor invading adjacent organs
  • T1 tumors that can be locally resected
  • Should take neoadjuvant therapy but refuse it
  • Recurrent cancer
  • Concurrent or previous diagnosis of invasive cancer within 5 years
  • Emergent surgery with intestinal obstruction or perforation
  • History of colorectal surgery
  • Fecal incontinence
  • History of inflammatory bowel disease
  • Contraindications to general anaesthesia (ASA class 4 or 5)
  • Pregnant or breast-feeding
  • History of mental disorder

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 16 locations

1

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

Beijing, Beijing Municipality, China, 100730

Actively Recruiting

2

Department of General Surgery, Daping Hospital, Army Medical university

Chongqing, Chongqing Municipality, China, 400042

Actively Recruiting

3

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

Guangzhou, Guangdong, China, 510000

Completed

4

Nanfang Hospital

Guangzhou, Guangdong, China, 510559

Actively Recruiting

5

The Affiliated Hospital of Guangdong Medical University

Zhanjiang, Guangdong, China, 524001

Actively Recruiting

6

Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, China, 563003

Actively Recruiting

7

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China, 410013

Actively Recruiting

8

The First Affiliated Hospital of University of South China

Hengyang, Hunan, China, 421001

Actively Recruiting

9

Department of Gastrointestinal Surgery, The First Hospital of Jilin University

Changchun, Jilin, China, 130021

Actively Recruiting

10

Department of Colorectal Surgery, Shengjing Hospital of China Medical University

Shenyang, Liaoning, China, 110004

Actively Recruiting

11

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China, 710061

Actively Recruiting

12

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China, 200025

Actively Recruiting

13

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

Shanghai, Shanghai Municipality, China, 200127

Actively Recruiting

14

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

Nanchong, Sichuan, China, 637000

Actively Recruiting

15

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

Yibin, Sichuan, China, 644000

Actively Recruiting

16

XinQiao Hospital of Army Medical University

Chongqing, China, 400037

Actively Recruiting

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Research Team

L

Liang Kang, MD,PHD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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