- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04573738
Safety and Feasibility Study of Robotic Assisted Transanal Total Mesorectal Excision for Rectal Cancer
November 23, 2023 updated by: Weidong Tong, Third Military Medical University
Total mesorectal excision has greatly reduced the local recurrence rate of rectal cancer after colorectal surgery.
Transanal total mesorectal excision(TaTME) is potentially a suitable option for patients with middle and low rectal cancer.
Robotic systems are expected to develop the advantages of TaTME to overcome the limitations of laparoscopic surgery.
This study aimed to investigate the safety and feasibility of robotic assisted transanal total mesorectal excision in patients with rectal cancer.
Study Overview
Status
Completed
Conditions
Detailed Description
TaTME is potentially a suitable option for patients with middle or low rectal cancer, especially for males with obesity and a narrow pelvis.The da Vinci robotic system (Intuitive Surgical, Sunnyvale, CA, USA) is expected to overcome the limitations of the laparoscopic transanal approach for rectal surgery.
Da Vinci Si Surgical System or da Vinci Xi Surgical System would be used to performed Transanal total mesorectal excision.
And the surgery would performed by two-team approach.
This study aimed to investigate the safety and feasibility of robotic assisted transanal total mesorectal excision in patients with rectal cancer.
Study Type
Interventional
Enrollment (Actual)
13
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Haode Shen, MD
- Phone Number: +8617783437391
- Email: imshd@qq.com
Study Contact Backup
- Name: Weidong Tong, MD
- Phone Number: 02368757955
- Email: vdtong@163.com
Study Locations
-
-
Chongqing
-
Chongqing, Chongqing, China, 400042
- Daping Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Pathological biopsy confirmed adenocarcinoma of the rectum.
- Preoperative assessment of tolerance to surgery without major organ dysfunction.
- Patients must be able to understand and voluntarily sign written informed consent.
- The surgical method is robotic assisted transanal total mesorectal excision
- Distance of the edge of the tumour within 8 cm
Exclusion Criteria:
- The patient cannot tolerate the operation.
- Refusal to sign informed consent.
- Patients with distant metastasis of rectal cancer.
- The surgical method was changed to miles or Hartman;
- Unable to complete the follow - up
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Robotic transanal surgery
Robotic assisted transanal total mesorectal excision for rectal cancer patients
|
Robotic assisted transanal total mesorectal excision for rectal cancer patients
|
Active Comparator: Laparoscopic transanal surgery
Laparoscopic transanal total mesorectal excision for rectal cancer patients
|
Laparoscopic assisted transanal total mesorectal excision for rectal cancer patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The local recurrence rates of rectal cancer
Time Frame: Two years after surgery
|
The incidence of local recurrence rectal cancer within two years after surgery
|
Two years after surgery
|
The incidence of postoperative anastomotic leakage
Time Frame: Within 30 days after surgery
|
The incidence of postoperative anastomotic leakage within 30 days after surgery
|
Within 30 days after surgery
|
The five-year survival rates
Time Frame: Five years after surgery
|
The 5-year survival rates of rectal cancer
|
Five years after surgery
|
The distant metastasis rates of rectal cancer
Time Frame: Five years after surgery
|
The incidence of distant metastasis rectal cancer within two years after surgery
|
Five years after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Weidong Tong, MD, Army Military Medical University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Jayne D, Pigazzi A, Marshall H, Croft J, Corrigan N, Copeland J, Quirke P, West N, Rautio T, Thomassen N, Tilney H, Gudgeon M, Bianchi PP, Edlin R, Hulme C, Brown J. Effect of Robotic-Assisted vs Conventional Laparoscopic Surgery on Risk of Conversion to Open Laparotomy Among Patients Undergoing Resection for Rectal Cancer: The ROLARR Randomized Clinical Trial. JAMA. 2017 Oct 24;318(16):1569-1580. doi: 10.1001/jama.2017.7219.
- Lee L, de Lacy B, Gomez Ruiz M, Liberman AS, Albert MR, Monson JRT, Lacy A, Kim SH, Atallah SB. A Multicenter Matched Comparison of Transanal and Robotic Total Mesorectal Excision for Mid and Low-rectal Adenocarcinoma. Ann Surg. 2019 Dec;270(6):1110-1116. doi: 10.1097/SLA.0000000000002862.
- Atallah S, Martin-Perez B, Pinan J, Quinteros F, Schoonyoung H, Albert M, Larach S. Robotic transanal total mesorectal excision: a pilot study. Tech Coloproctol. 2014 Nov;18(11):1047-53. doi: 10.1007/s10151-014-1181-5. Epub 2014 Jun 24.
- Ye J, Tian Y, Wang L, Ye Y, Zhang Y, Li F, Liu B, Tong W. [Robotic-assisted transanal total mesorectal excision for lower rectal cancer]. Zhonghua Wei Chang Wai Ke Za Zhi. 2017 Aug 25;20(8):900-903. Chinese.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2017
Primary Completion (Actual)
May 31, 2020
Study Completion (Actual)
September 30, 2021
Study Registration Dates
First Submitted
September 15, 2020
First Submitted That Met QC Criteria
September 28, 2020
First Posted (Actual)
October 5, 2020
Study Record Updates
Last Update Posted (Actual)
November 27, 2023
Last Update Submitted That Met QC Criteria
November 23, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20200913
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Rectal Cancer
-
Ohio State University Comprehensive Cancer CenterNovartis Pharmaceuticals; National Comprehensive Cancer NetworkCompletedStage IIA Rectal Cancer | Stage IIB Rectal Cancer | Stage IIC Rectal Cancer | Stage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Recurrent Rectal CancerUnited States
-
M.D. Anderson Cancer CenterRecruitingEvaluation of Quality of Life and Utilities Following Surgical Treatment of Stage I-IV Rectal CancerStage III Rectal Cancer AJCC v8 | Stage IIIA Rectal Cancer AJCC v8 | Stage IIIB Rectal Cancer AJCC v8 | Stage IIIC Rectal Cancer AJCC v8 | Stage IV Rectal Cancer AJCC v8 | Stage IVA Rectal Cancer AJCC v8 | Stage IVB Rectal Cancer AJCC v8 | Stage IVC Rectal Cancer AJCC v8 | Rectal Adenocarcinoma | Stage... and other conditionsUnited States
-
OHSU Knight Cancer InstituteNatera, Inc.RecruitingEstablishing a ctDNA Biomarker to Improve Organ Preserving Strategies in Patients With Rectal CancerStage III Rectal Cancer AJCC v8 | Stage IIIA Rectal Cancer AJCC v8 | Stage IIIB Rectal Cancer AJCC v8 | Stage IIIC Rectal Cancer AJCC v8 | Rectal Adenocarcinoma | Stage IIA Rectal Cancer AJCC v8 | Stage IIB Rectal Cancer AJCC v8 | Stage II Rectal Cancer AJCC v8 | Stage IIC Rectal Cancer AJCC v8United States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Not yet recruitingStage III Rectal Cancer AJCC v8 | Stage IIIA Rectal Cancer AJCC v8 | Stage IIIB Rectal Cancer AJCC v8 | Stage IIIC Rectal Cancer AJCC v8 | Rectal Adenocarcinoma | Stage IIA Rectal Cancer AJCC v8 | Stage IIB Rectal Cancer AJCC v8 | Stage II Rectal Cancer AJCC v8 | Stage IIC Rectal Cancer AJCC v8United States
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI)WithdrawnStage IIA Rectal Cancer | Stage IIB Rectal Cancer | Stage IIC Rectal Cancer | Stage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Rectal AdenocarcinomaUnited States
-
OHSU Knight Cancer InstituteOregon Health and Science University; Taiho Pharmaceutical Co., Ltd.RecruitingStage III Rectal Cancer AJCC v8 | Stage IIIA Rectal Cancer AJCC v8 | Stage IIIB Rectal Cancer AJCC v8 | Stage IIIC Rectal Cancer AJCC v8 | Rectal Adenocarcinoma | Stage IIA Rectal Cancer AJCC v8 | Stage IIB Rectal Cancer AJCC v8United States
-
Jonsson Comprehensive Cancer CenterNatera, Inc.; The Joseph Drown FoundationRecruitingStage III Rectal Cancer AJCC v8 | Stage IIIA Rectal Cancer AJCC v8 | Stage IIIB Rectal Cancer AJCC v8 | Stage IIIC Rectal Cancer AJCC v8 | Rectal Adenocarcinoma | Stage IIA Rectal Cancer AJCC v8 | Stage IIB Rectal Cancer AJCC v8 | Stage II Rectal Cancer AJCC v8 | Stage IIC Rectal Cancer AJCC v8 | Locally...United States
-
Case Comprehensive Cancer CenterCompletedStage IIA Rectal Cancer | Stage IIB Rectal Cancer | Stage IIC Rectal Cancer | Stage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon Cancer | Recurrent Colon Cancer | Recurrent Rectal Cancer | Stage IVA Colon Cancer | Stage IVA Rectal Cancer and other conditionsUnited States
-
City of Hope Medical CenterWithdrawnRecurrent Rectal Cancer | Stage I Rectal Cancer | Stage II Rectal Cancer | Stage III Rectal Cancer
-
National Cancer Institute (NCI)Active, not recruitingMetastatic Rectal Adenocarcinoma | Rectal Adenocarcinoma | Stage III Rectal Cancer AJCC v7 | Stage IIIA Rectal Cancer AJCC v7 | Stage IIIB Rectal Cancer AJCC v7 | Stage IIIC Rectal Cancer AJCC v7 | Stage IV Rectal Cancer AJCC v7 | Stage IVA Rectal Cancer AJCC v7 | Stage IVB Rectal Cancer AJCC v7 | Locally...United States
Clinical Trials on Robotic assisted transanal total mesorectal excision
-
University Hospital Gregorio MarañónHospital del Río Hortega; Hospital de Leon; University of Navarrra Hospital (Clinica...RecruitingRectal Cancer | Sphincter Ani IncontinenceSpain
-
National Cancer Center, KoreaActive, not recruitingRectal CancerKorea, Republic of
-
Chinese University of Hong KongUnknown
-
The First Hospital of Jilin UniversityJilin Provincial Tumor Hospital; Daping Hospital and the Research Institute... and other collaboratorsNot yet recruitingRectal Neoplasms | Laparoscopy | Robotic Surgical Procedures | Total Mesorectal ExcisionChina
-
Sun Yat-sen UniversityCompleted
-
Yanhong DengCompleted
-
Ruijin HospitalWithdrawn
-
National Cancer Center, KoreaActive, not recruitingRectal CancerKorea, Republic of
-
Cantonal Hospital of St. GallenRecruitingRecurrence | Mortality | Survival | Postoperative MorbiditySwitzerland
-
National Cancer Center, KoreaCompletedRectal CancerKorea, Republic of