Transanal Versus Laparoscopic Total Mesorectal Excision for Mid and Low Rectal Cancer (TaLaR): a Multicentre Randomised Clinical Trial

Status: Recruiting
Location: See all (16) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Department of General Surgery, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences
RECRUITING
Beijing
Department of Gastrointestinal Surgery, The First Hospital of Jilin University
RECRUITING
Changchun
The Third Xiangya Hospital of Central South University
RECRUITING
Changsha
Department of General Surgery, Daping Hospital, Army Medical university
RECRUITING
Chongqing
XinQiao Hospital of Army Medical University
RECRUITING
Chongqing
Department of colorectal surgery, the Sixth Affiliated Hospital, Sun Yat-Sen University
COMPLETED
Guangzhou
Nanfang Hospital
RECRUITING
Guangzhou
The First Affiliated Hospital of University of South China
RECRUITING
Hengyang
Department of Gastrointestinal Surgery,The Affiliated Nanchong Central Hospital of North Sichuan Medical College
RECRUITING
Nanchong
Department of Gastrointestinal Surgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University,
RECRUITING
Shanghai
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
RECRUITING
Shanghai
Department of Colorectal Surgery, Shengjing Hospital of China Medical University
RECRUITING
Shenyang
The First Affiliated Hospital of Xi'an Jiaotong University
RECRUITING
Xi'an
Department of gastrointestinal surgery, the Second People's Hospital of Yibin
RECRUITING
Yibin
The Affiliated Hospital of Guangdong Medical University
RECRUITING
Zhanjiang
Affiliated Hospital of Zunyi Medical University
RECRUITING
Zunyi
Contact Information
Primary
Liang Kang, MD,PHD
eonkang@163.com
008613602886833
Time Frame
Start Date: 2016-04
Estimated Completion Date: 2026-07
Participants
Target number of participants: 1114
Treatments
Experimental: Transanal Total Mesorectal Excision
The rectum is mobilized and resected transanally (from bottom to up) according to TME principles, via transanal platform (either rigid or flexible platform).An ideal TaTME is defined as the extraperitoneal portion of the rectum being mobilized from below.
Active_comparator: Laparoscopic Total Mesorectal Excision
The traditional laparoscopic TME (LpTME) was performed via standard laparoscopic techniques, including multiple trocars and conventional laparoscopic instruments.
Related Therapeutic Areas
Sponsors
Collaborators: Affiliated Hospital of Guangdong Medical University, Peking Union Medical College Hospital, Ruijin Hospital, RenJi Hospital, Xinqiao Hospital, First Affiliated Hospital Xi'an Jiaotong University, The Third Xiangya Hospital of Central South University, The Second People's Hospital of Yibin, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, Shengjing Hospital, Nanfang Hospital, Southern Medical University, The First Affiliated Hospital of University of South China, The First Hospital of Jilin University, Nanchong Central Hospital, Zunyi Medical College
Leads: Sun Yat-sen University

This content was sourced from clinicaltrials.gov