Actively Recruiting
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
Eligibility Criteria
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
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
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
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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