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
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
TaTME
Procedure/SurgeryTransanal Total Mesorectal Excision
LpTME
Procedure/SurgeryConventional Laparoscopic Total Mesorectal Excision
Treatment groups
Trial outcomes
Primary outcomes
Disease-free survival
Disease-free survival
Overall survival
Overall survival
Secondary outcomes
Positive circumferential resection margin (CRM)
Involved CRM (tumor cells \<1mm)
Overall survival
Overall survival
Mesorectal completeness
The quality of the mesorectum or TME specimen (complete;nearly complete; incomplete)
Number of retrieved lymph nodes
Number of retrieved lymph nodes
Sponsors and contacts
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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