Transanal Versus Laparoscopic Total Mesorectal Excision for Rectal Cancer

Recruiting now · Not applicable

Conditions studied: Rectal Neoplasms Malignant, Surgery

In brief

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.

Key facts

Study ID

NCT02966483

Run by

Sun Yat-sen University

People needed

1114

Starts

2016-04-01

Expected to finish

2026-07-01

Last updated by the study team

2025-01-17

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• could not 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;
• with contraindications to general anaesthesia(ASA class 4 or 5);
• pregnant or breast-feeding;
• history of mental disorder

Where it is running

• XinQiao Hospital of Army Medical University — Chongqing, China (enrolling)
• Department of General Surgery, Daping Hospital, Army Medical university — Chongqing, Chongqing Municipality, China (enrolling)
• Department of General Surgery, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (enrolling)
• Nanfang Hospital — Guangzhou, Guangdong, China (enrolling)
• The Affiliated Hospital of Guangdong Medical University — Zhanjiang, Guangdong, China (enrolling)
• Affiliated Hospital of Zunyi Medical University — Zunyi, Guizhou, China (enrolling)
• The Third Xiangya Hospital of Central South University — Changsha, Hunan, China (enrolling)
• The First Affiliated Hospital of University of South China — Hengyang, Hunan, China (enrolling)
• Department of Gastrointestinal Surgery, The First Hospital of Jilin University — Changchun, Jilin, China (enrolling)
• Department of Colorectal Surgery, Shengjing Hospital of China Medical University — Shenyang, Liaoning, China (enrolling)
• The First Affiliated Hospital of Xi'an Jiaotong University — Xi'an, Shaanxi, China (enrolling)
• Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (enrolling)
• Department of Gastrointestinal Surgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, — Shanghai, Shanghai Municipality, China (enrolling)
• Department of Gastrointestinal Surgery，The Affiliated Nanchong Central Hospital of North Sichuan Medical College — Nanchong, Sichuan, China (enrolling)
• Department of gastrointestinal surgery, the Second People's Hospital of Yibin — Yibin, Sichuan, China (enrolling)
• Department of colorectal surgery, the Sixth Affiliated Hospital, Sun Yat-Sen University — Guangzhou, Guangdong, China

Full record on ClinicalTrials.gov

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