Transanal Versus Laparoscopic Total Mesorectal Excision For Rectal Cancer
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| ClinicalTrials.gov Identifier: NCT02966483 |
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Recruitment Status :
Recruiting
First Posted : November 17, 2016
Last Update Posted : November 7, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Rectal Neoplasms Malignant Surgery | Procedure: TaTME Procedure: LpTME | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 1114 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Transanal or Laparoscopic Total Mesorectal Excision treat rectal cancer |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Transanal Versus Laparoscopic Total Mesorectal Excision For Mid And Low Rectal Cancer (TaLaR): A Multicentre Randomised Clinical Trial |
| Actual Study Start Date : | April 2016 |
| Estimated Primary Completion Date : | July 2025 |
| Estimated Study Completion Date : | July 2025 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Procedure: TaTME
Transanal Total Mesorectal Excision
Other Name: Transanal TME |
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Active Comparator: Laparoscopic Total Mesorectal Excision
The traditional laparoscopic TME (LpTME) was performed via standard laparoscopic techniques, including multiple trocars and conventional laparoscopic instruments.
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Procedure: LpTME
Conventional Laparoscopic Total Mesorectal Excision
Other Name: Laparoscopic TME |
- Disease-free survival [ Time Frame: 3 years ]Disease-free survival
- Overall survival [ Time Frame: 5 years ]Overall survival
- Positive circumferential resection margin (CRM) [ Time Frame: 3 years ]Involved CRM (tumor cells <1mm)
- Overall survival [ Time Frame: 10 years ]Overall survival
- Mesorectal completeness [ Time Frame: 3 years ]The quality of the mesorectum or TME specimen (complete;nearly complete; incomplete)
- Number of retrieved lymph nodes [ Time Frame: 3 years ]Number of retrieved lymph nodes
- Morbidity rate [ Time Frame: 1 years ]Morbidity rate
- Mortality rate [ Time Frame: 1 years ]Mortality rate
- Anorectal function outcomes [ Time Frame: 3 years ]To evaluate defecating function with Wexner score
- Sexual functional outcomes [ Time Frame: 3 years ]To evaluate sexual function with IIEF(International Index of Erectile Function) questionnaire
- The patient's Quality of life: EORTC QLQ-30 questionnaire [ Time Frame: 3 years ]To evaluate quality of life with EORTC QLQ-30 questionnaire
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02966483
| Contact: Liang Kang, MD,PHD | 008613602886833 | eonkang@163.com |
| China, Beijing | |
| Department of General Surgery, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences | Recruiting |
| Beijing, Beijing, China, 100730 | |
| Contact: Yi Xiao, MD, PhD 008613366036387 XiaoY@pumch.cn | |
| China, Chongqing | |
| Department of General Surgery, Daping Hospital, Army Medical university | Recruiting |
| Chongqing, Chongqing, China, 400042 | |
| Contact: Weidong Tong, MD, PhD 008613500321218 vdtong@163.com | |
| China, Guangdong | |
| Department of colorectal surgery, the Sixth Affiliated Hospital, Sun Yat-Sen University | Recruiting |
| Guangzhou, Guangdong, China, 510000 | |
| Contact: Liang Kang, MD, PhD 008613602886833 eonkang@163.com | |
| Nanfang Hospital | Recruiting |
| Guangzhou, Guangdong, China, 510559 | |
| Contact: Yanan Wang, MD.PhD | |
| The Affiliated Hospital of Guangdong Medical University | Recruiting |
| Zhanjiang, Guangdong, China, 524001 | |
| Contact: Qingwen Xu, MD 008613600387083 xuqwen@21cn.com | |
| China, Guizhou | |
| Affiliated Hospital of Zunyi Medical University | Recruiting |
| Zunyi, Guizhou, China, 563003 | |
| Contact: Ming Xie, MD 008615519202000 2581303091@qq.com | |
| China, Hunan | |
| The Third Xiangya Hospital of Central South University | Recruiting |
| Changsha, Hunan, China, 410013 | |
| Contact: Yi Zhang, MD,PhD | |
| The First Affiliated Hospital of University of South China | Recruiting |
| Hengyang, Hunan, China, 421001 | |
| Contact: Jun Ouyang, MD 008613973426200 1847039906@qq.com | |
| China, Jilin | |
| Department of Gastrointestinal Surgery, The First Hospital of Jilin University | Recruiting |
| Changchun, Jilin, China, 130021 | |
| Contact: Quan Wang, MD,PhD 008615843073207 wangquanjdyy@163.com | |
| China, Liaoning | |
| Department of Colorectal Surgery, Shengjing Hospital of China Medical University | Recruiting |
| Shenyang, Liaoning, China, 110004 | |
| Contact: Hong Zhang, MD 008618940257919 haojiubujian1203@sina.cn | |
| China, Shaanxi | |
| The First Affiliated Hospital of Xi'an Jiaotong University | Recruiting |
| Xi'an, Shaanxi, China, 710061 | |
| Contact: Yongchun Song, MD 008618991232549 dr.songyongchun@qq.com | |
| China, Shanghai | |
| Ruijin Hospital, Shanghai Jiao Tong University School of Medicine | Recruiting |
| Shanghai, Shanghai, China, 200025 | |
| Contact: Bo Feng, MD,PhD 008613512103996 fengbo2022@163.com | |
| Department of Gastrointestinal Surgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, | Recruiting |
| Shanghai, Shanghai, China, 200127 | |
| Contact: Qing Xu, MD, PhD 008613761002053 renjixuqing@163.com | |
| China, Sichuan | |
| Department of Gastrointestinal Surgery，The Affiliated Nanchong Central Hospital of North Sichuan Medical College | Recruiting |
| Nanchong, Sichuan, China, 637000 | |
| Contact: Mingyang Ren, MD 008613890756 2861746489@qq.com | |
| Department of gastrointestinal surgery, the Second People's Hospital of Yibin | Recruiting |
| Yibin, Sichuan, China, 644000 | |
| Contact: Miao Wu, MD 008613990905852 13990905852@163.com | |
| China | |
| XinQiao Hospital of Army Medical University | Recruiting |
| Chongqing, China, 400037 | |
| Contact: Dan Ma, MD,Phd 008615823555665 1054727918@qq.com | |
| Principal Investigator: | Jianping Wang, MD,PHD | The Sixth Affiliated Hospital, Sun Yat-sen University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Yanhong Deng, MD, Sun Yat-sen University |
| ClinicalTrials.gov Identifier: | NCT02966483 |
| Other Study ID Numbers: |
SYSU-RECTAl-2016 |
| First Posted: | November 17, 2016 Key Record Dates |
| Last Update Posted: | November 7, 2022 |
| Last Verified: | November 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Device Product: | No |
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Rectal cancer Laparoscopic surgery Total mesorectal excision Transanal Multicentre randomised clinical trial |
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Rectal Neoplasms Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms |
Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases |