A Trial of Robotic-assisted Versus Laparoscopic Abdominoperineal Resection for Treating Low Rectal Cancer

Study Overview
=================
Brief Summary
-----------------
In this study, the investigators assessed the difference in efficacy and safety among robotic-assisted versus laparoscopic abdominoperineal resection for patients with low rectal cancer.

Detailed Description
-----------------
Patients will be eligible for inclusion if their primary tumors is low rectal cancer. Eligible patients will be randomly assigned to robotic-assisted (arm A) versus laparoscopic (arm B) abdominoperineal resection.

Official Title
-----------------
A Single-centre, Prospective, Randomised, Controlled, Unblinded, Parallel-group Trial of Robotic-assisted Versus Laparoscopic Abdominoperineal Resection for the Curative Treatment of Low Rectal Cancer

Conditions
-----------------
Rectal Cancer

Intervention / Treatment
-----------------
* Procedure: Robotic-assisted resection.
* Procedure: Laparoscopic resection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically proven rectal adenocarcinoma Inferior edge of the tumor located within 5 cm from the anal verge as determined by colonoscopy withdrawing and digital rectal examination No evidence of distant metastases (including pelvis, peritoneum, liver, lung, brain, bone, distant lymph node, etc) according to ultrasound, CT, PET-CT, etc Tumor assessed as cT1-T3 or ycT1-T3 after preoperative neoadjuvant chemoradiotherapy by pelvic MRI No other malignancies in medical history except adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri Suitable for both robot-assisted and laparoscopic surgery American Society of Anesthesiologists (ASA) class I - III No other preoperative treatment except neoadjuvant chemoradiotherapy Informed consent Exclusion Criteria: Tumors assessed as cT1N0 and suitable for local excision Signs of acute intestinal obstruction, bleeding or perforation needing emergency surgery More than one colorectal tumor Familial Adenomatosis Polyposis, Lynch Syndrome, acute inflammatory bowel disease Schedules need for other synchronous colon surgery Absolute contraindications to general anesthesia or prolonged pneumoperitoneum (ASA class > III) Pregnancy or lactation Patients and/or family members can not understand and accept this study Patients received chemoradiotherapy or other anti-tumor therapy before surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robotic-assisted resection<br>patients with low rectal cancer receiving robotic-assisted abdominoperineal resection. | Procedure: Robotic-assisted resection.<br>* Robotic-assisted abdominoperineal resection.<br>|
| Active Comparator: Laparoscopic resection<br>patients with low rectal cancer receiving laparoscopic abdominoperineal resection. | Procedure: Laparoscopic resection<br>* Laparoscopic abdominoperineal resection<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative complications | postoperative complications related to operation | 30 days post operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operative mortality | death occurred 30 days after operation | 30 days post operatively | 
| disease-free survival | disease-free survival rate at 3 years after operation | 3 years | 
| overall survival | overall survival rate at 3 and 5 years after operation | 3 and 5 years | 
| locoregional recurrence rate | local recurrence rate at 3 and 5 years after operation | 3 and 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Low rectal cancer, Robotic, Laparoscopic, Abdominoperineal resection