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Safety and Feasibility Study of Robotic Assisted Transanal Total Mesorectal Excision for Rectal Cancer

Primary Purpose

Rectal Cancer, Perioperative Complication

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Robotic assisted transanal total mesorectal excision
Laparoscopic assisted transanal total mesorectal excision
Sponsored by
Third Military Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring Rectal Cancer, Robotic surgery

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Daping hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Robotic transanal surgery

Laparoscopic transanal surgery

Arm Description

Robotic assisted transanal total mesorectal excision for rectal cancer patients

Laparoscopic transanal total mesorectal excision for rectal cancer patients

Outcomes

Primary Outcome Measures

The local recurrence rates of rectal cancer
The incidence of local recurrence rectal cancer within two years after surgery
The incidence of postoperative anastomotic leakage
The incidence of postoperative anastomotic leakage within 30 days after surgery
The five-year survival rates
The 5-year survival rates of rectal cancer
The distant metastasis rates of rectal cancer
The incidence of distant metastasis rectal cancer within two years after surgery

Secondary Outcome Measures

Full Information

First Posted
September 15, 2020
Last Updated
April 17, 2022
Sponsor
Third Military Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04573738
Brief Title
Safety and Feasibility Study of Robotic Assisted Transanal Total Mesorectal Excision for Rectal Cancer
Official Title
Safety and Feasibility Study of Robotic Assisted Transanal Total Mesorectal Excision for Rectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Third Military Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer, Perioperative Complication
Keywords
Rectal Cancer, Robotic surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Robotic transanal surgery
Arm Type
Experimental
Arm Description
Robotic assisted transanal total mesorectal excision for rectal cancer patients
Arm Title
Laparoscopic transanal surgery
Arm Type
Active Comparator
Arm Description
Laparoscopic transanal total mesorectal excision for rectal cancer patients
Intervention Type
Procedure
Intervention Name(s)
Robotic assisted transanal total mesorectal excision
Intervention Description
Robotic assisted transanal total mesorectal excision for rectal cancer patients
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic assisted transanal total mesorectal excision
Intervention Description
Laparoscopic assisted transanal total mesorectal excision for rectal cancer patients
Primary Outcome Measure Information:
Title
The local recurrence rates of rectal cancer
Description
The incidence of local recurrence rectal cancer within two years after surgery
Time Frame
Two years after surgery
Title
The incidence of postoperative anastomotic leakage
Description
The incidence of postoperative anastomotic leakage within 30 days after surgery
Time Frame
Within 30 days after surgery
Title
The five-year survival rates
Description
The 5-year survival rates of rectal cancer
Time Frame
Five years after surgery
Title
The distant metastasis rates of rectal cancer
Description
The incidence of distant metastasis rectal cancer within two years after surgery
Time Frame
Five years after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haode Shen, MD
Phone
+8617783437391
Email
imshd@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Weidong Tong, MD
Phone
02368757955
Email
vdtong@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weidong Tong, MD
Organizational Affiliation
Army Military Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Daping hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weidong Tong, Prof
Phone
86-023-68757956
Email
tongweidong@gmail.com
First Name & Middle Initial & Last Name & Degree
Weidong Tong, Prof
Phone
86-13500321218
Email
vdtong@163.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29916871
Citation
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.
Results Reference
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PubMed Identifier
29067426
Citation
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.
Results Reference
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PubMed Identifier
24957360
Citation
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.
Results Reference
background
PubMed Identifier
28836251
Citation
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.
Results Reference
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Safety and Feasibility Study of Robotic Assisted Transanal Total Mesorectal Excision for Rectal Cancer

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