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

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:

  1. Pathological biopsy confirmed adenocarcinoma of the rectum.
  2. Preoperative assessment of tolerance to surgery without major organ dysfunction.
  3. Patients must be able to understand and voluntarily sign written informed consent.
  4. The surgical method is robotic assisted transanal total mesorectal excision
  5. Distance of the edge of the tumour within 8 cm

Exclusion Criteria:

  1. The patient cannot tolerate the operation.
  2. Refusal to sign informed consent.
  3. Patients with distant metastasis of rectal cancer.
  4. The surgical method was changed to miles or Hartman;
  5. 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.

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

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.

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