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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Rectal Cancer, Perioperative Complication

Intervention / Treatment
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* Procedure: Robotic assisted transanal total mesorectal excision
* Procedure: Laparoscopic assisted transanal total mesorectal excision


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robotic transanal surgery<br>Robotic assisted transanal total mesorectal excision for rectal cancer patients | Procedure: Robotic assisted transanal total mesorectal excision<br>* Robotic assisted transanal total mesorectal excision for rectal cancer patients<br>|
| Active Comparator: Laparoscopic transanal surgery<br>Laparoscopic transanal total mesorectal excision for rectal cancer patients | Procedure: Laparoscopic assisted transanal total mesorectal excision<br>* Laparoscopic assisted transanal total mesorectal excision for rectal cancer patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rectal Cancer, Robotic surgery