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

Third Military Medical University13 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Rectal Cancer Perioperative Complication

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

The local recurrence rates of rectal cancer

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

Time frame: Two years after surgery

The incidence of postoperative anastomotic leakage

The incidence of postoperative anastomotic leakage within 30 days after surgery

Time frame: Within 30 days after surgery

The five-year survival rates

The 5-year survival rates of rectal cancer

Time frame: Five years after surgery

The distant metastasis rates of rectal cancer

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