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

Not Applicable

Completed

• Conditions: Rectal Cancer; Perioperative Complication
• Interventions: Procedure: Laparoscopic assisted transanal total mesorectal excision; Procedure: Robotic assisted transanal total mesorectal excision

• Registration Number: NCT04573738
• Lead Sponsor: Third Military Medical University

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.

Study Timeline

• Study Start: 2017-05-01
• Primary Completion: 2020-05-31
• Study First Submitted: 2020-09-15
• Study First Submitted QC: 2020-09-28
• Study First Posted: 2020-10-05
• Study Completion: 2021-09-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-23
• Last Update Posted: 2023-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laparoscopic transanal surgery	Laparoscopic assisted transanal total mesorectal excision	Laparoscopic transanal total mesorectal excision for rectal cancer patients
Robotic transanal surgery	Robotic assisted transanal total mesorectal excision	Robotic assisted transanal total mesorectal excision for rectal cancer patients

Primary Outcome Measures

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

Trial Locations

Locations (1)

Daping hospital; 🇨🇳 Chongqing, Chongqing, China