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

NCT04573738 | Completed DMC

• 1 other identifier: 20200913
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Cancer; Perioperative Complication

Keywords

Rectal Cancer; Robotic surgery

Outcome Measures

Primary Outcomes (4)

• The local recurrence rates of rectal cancer

  The incidence of local recurrence rectal cancer within two years after surgery

  Two years after surgery

• The incidence of postoperative anastomotic leakage

  The incidence of postoperative anastomotic leakage within 30 days after surgery

  Within 30 days after surgery

• The five-year survival rates

  The 5-year survival rates of rectal cancer

  Five years after surgery

• The distant metastasis rates of rectal cancer

  The incidence of distant metastasis rectal cancer within two years after surgery

  Five years after surgery

Study Arms (2)

Robotic transanal surgery

EXPERIMENTAL

Robotic assisted transanal total mesorectal excision for rectal cancer patients

Procedure: Robotic assisted transanal total mesorectal excision

Laparoscopic transanal surgery

ACTIVE COMPARATOR

Laparoscopic transanal total mesorectal excision for rectal cancer patients

Procedure: Laparoscopic assisted transanal total mesorectal excision

Interventions

Robotic assisted transanal total mesorectal excision PROCEDURE

Robotic assisted transanal total mesorectal excision for rectal cancer patients

Robotic transanal surgery

Laparoscopic assisted transanal total mesorectal excision PROCEDURE

Laparoscopic assisted transanal total mesorectal excision for rectal cancer patients

Laparoscopic transanal surgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Third Military Medical University: lead

Study Sites (1)

Daping hospital

Chongqing, Chongqing Municipality, 400042, China

Location

Related Publications (4)

• 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.

  PMID: 29916871 BACKGROUND

• 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.

  PMID: 29067426 BACKGROUND

• 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.

  PMID: 24957360 BACKGROUND

• 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.

  PMID: 28836251 BACKGROUND

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Weidong Tong, MD

  Army Military Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 15, 2020
• First Posted: October 5, 2020
• Study Start: May 1, 2017
• Primary Completion: May 31, 2020
• Study Completion: September 30, 2021
• Last Updated: November 27, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)