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

Third Military Medical University

Status: Completed

Conditions: Perioperative Complication; Rectal Cancer

Treatments: Procedure: Laparoscopic assisted transanal total mesorectal excision; Procedure: Robotic assisted transanal total mesorectal excision

Study type: Interventional

Funder types: Other

Identifiers

NCT04573738

20200913

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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13 participants in 2 patient groups

Robotic transanal surgery

Experimental group

Description:

Robotic assisted transanal total mesorectal excision for rectal cancer patients

Treatment:

Procedure: Robotic assisted transanal total mesorectal excision

Laparoscopic transanal surgery

Active Comparator group

Description:

Laparoscopic transanal total mesorectal excision for rectal cancer patients

Treatment:

Procedure: Laparoscopic assisted transanal total mesorectal excision