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Completed

NCT Number: NCT04573738

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

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.

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Key information

Conditions

Rectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Perioperative Complication Rectal Diseases Rectal Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Daping hospital

Chongqing, Chongqing Municipality, 400042, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Robotic assisted transanal total mesorectal excision

Procedure

Robotic assisted transanal total mesorectal excision for rectal cancer patients

Laparoscopic assisted transanal total mesorectal excision

Procedure

Laparoscopic assisted transanal total mesorectal excision for rectal cancer patients

Primary outcomes

  1. 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

  2. The incidence of postoperative anastomotic leakage

    Time frame: Within 30 days after surgery

    The incidence of postoperative anastomotic leakage within 30 days after surgery

  3. The five-year survival rates

    Time frame: Five years after surgery

    The 5-year survival rates of rectal cancer

  4. 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

Sponsors and collaborators

Lead sponsor

Third Military Medical University

Other

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Oct 5, 2020
Registry last updated
Nov 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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