Transanal Versus Laparoscopic Total Mesorectal Excision For Rectal Cancer

Surgery Clinical Trial

Official title:

Transanal Versus Laparoscopic Total Mesorectal Excision For Mid And Low Rectal Cancer (TaLaR): A Multicentre Randomised Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02966483
• Other study ID #: SYSU-RECTAl-2016
• Status: Recruiting
• Phase: N/A
• Start date: April 2016
• Est. completion date: July 2025

Study information

• Verified date: November 2022
• Source: Sun Yat-sen University
• Contact: Liang Kang, MD,PHD
• Phone: 008613602886833
• Email: eonkang[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Background:In recent years, transanal mesorectal excision (TaTME) has emerged as a promising surgical alternative for rectal cancer, especially for mid and low rectal cancer. Theoretically, TaTME holds the potential advantage of providing better access to mobilize the distal rectum, and thus could achieve better pathologic outcomes, such as lower involved circumferential margin (CRM) and incomplete resected mesorectum, which could translate into better oncological outcome for the patients in the long term. However, until now, the feasibility and the non-inferiority (compared with laparoscopic total mesorectal excision, LpTME) of this technique has only been validated in studies with limitations of small sample size, retrospective nature.

Study Objective:This study aims to evaluate the TaTME technique compared with conventional laparoscopic rectal surgery, focusing on resection quality, as well as long-term survival results.

Study design This study is a prospective, multi-center, randomized, open-label, parallel group trial. The randomisation ratio of TaTME over LpTME will be 1:1. A central electronic data capture (EDC) system will be utilized for randomization, electronic CRF and data collection. All comparative analyses will be conducted on an "intention to treat" basis.

Sample size: Sample-size calculation of this trial based on 3-year DFS and 5-year OS; but the sample size according to 5-year OS was larger than that based on 3-year DFS. The expected 5-year OS among clinical stage I-III rectal cancer patients treated with laTME was 77·4%. Allowing a difference of 10% as the non-inferiority margin, 910 patients would be required to sufficiently declare taTME noninferior to laTME in 5-year OS based on a log-rank test with an α error of 2·5% (in a two-sided test) and power of 80%. Assuming a dropout rate of 20%, a total of 1114 patients were planned to enroll for this trial.

Study Endpoints:The primary end point of this study is 3-year disease-free survival (DFS) rate and a 5-year overall survival (OS) rate. Secondary endpoints include: 1) resection quality, mainly including circumferential involvement rate, and completeness of mesorectum. Resected specimen was pathologically processed and assessed at each center by trained and qualified pathologists independently.2)short term operative results such as morbidity and mortality, etc.; 3) long term oncological outcome such as local recurrence, and overall survival. Besides, functional outcome and quality of life are also evaluated.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1114
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Neoplasms
• Rectal Neoplasms
• Rectal Neoplasms Malignant
• Surgery

Intervention

Procedure:
• TaTME
Transanal Total Mesorectal Excision
• LpTME
Conventional Laparoscopic Total Mesorectal Excision

Locations

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

Sponsors (16)

Lead Sponsor

Collaborator

Sun Yat-sen University

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, First Affiliated Hospital Xi'an Jiaotong University, Nanchong Central Hospital, Nanfang Hospital of Southern Medical University, Peking Union Medical College Hospital, RenJi Hospital, Ruijin Hospital, Shengjing Hospital, The Affiliated Hospital of Guangdong Medical College, The First Affiliated Hospital of University of South China, The First Hospital of Jilin University, The Second People's Hospital of Yibin, The Third Xiangya Hospital of Central South University, Xinqiao Hospital, Zunyi Medical College

Country where clinical trial is conducted

China, 

References & Publications (2)

Chen WH, Kang L, Luo SL, Zhang XW, Huang Y, Liu ZH, Wang JP. Transanal total mesorectal excision assisted by single-port laparoscopic surgery for low rectal cancer. Tech Coloproctol. 2015 Sep;19(9):527-34. doi: 10.1007/s10151-015-1342-1. Epub 2015 Jul 29. — View Citation

Kang L, Chen WH, Luo SL, Luo YX, Liu ZH, Huang MJ, Wang JP. Transanal total mesorectal excision for rectal cancer: a preliminary report. Surg Endosc. 2016 Jun;30(6):2552-62. doi: 10.1007/s00464-015-4521-2. Epub 2015 Aug 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival	Disease-free survival	3 years
Primary	Overall survival	Overall survival	5 years
Secondary	Positive circumferential resection margin (CRM)	Involved CRM (tumor cells <1mm)	3 years
Secondary	Overall survival	Overall survival	10 years
Secondary	Mesorectal completeness	The quality of the mesorectum or TME specimen (complete;nearly complete; incomplete)	3 years
Secondary	Number of retrieved lymph nodes	Number of retrieved lymph nodes	3 years
Secondary	Morbidity rate	Morbidity rate	1 years
Secondary	Mortality rate	Mortality rate	1 years
Secondary	Anorectal function outcomes	To evaluate defecating function with Wexner score	3 years
Secondary	Sexual functional outcomes	To evaluate sexual function with IIEF(International Index of Erectile Function) questionnaire	3 years
Secondary	The patient's Quality of life: EORTC QLQ-30 questionnaire	To evaluate quality of life with EORTC QLQ-30 questionnaire	3 years