Randomized Trial on Robotic Assisted Resection for Rectal Cancer

Study Overview
=================
Brief Summary
-----------------
Hypothesis: the bladder and sexual functions can be better preserved in patients with robotic assisted rectal surgery This is a randomized trial comparing the bladder and sexual function of patients who undergo laparoscopic and robotic assisted rectal resection for rectal cancer.

Detailed Description
-----------------
This is a randomized trial comparing the bladder and sexual function of patients who undergo laparoscopic and robotic assisted rectal resection for rectal cancer The primary objective of this study is to compare the bladder and sexual functions of patients who undergo laparoscopic and robotic assisted resection for rectal cancer through a randomized controlled trial. The secondary outcome measures include The operative outcome in terms of the complication rate, hospital stay and reoperation of the two groups; The quality of life of the patients and the cost of the two groups The quality of the resected specimens The local recurrence rates at two years after the surgery

Official Title
-----------------
Randomized Controlled Trial Comparing the Bladder and Sexual Functions of Patients Who Undergo Laparoscopic and Robotic Assisted Resection for Rectal Cancer

Conditions
-----------------
Rectal Cancer, Adenocarcinoma

Intervention / Treatment
-----------------
* Procedure: robotic assisted rectal resection
* Procedure: laparoscopic rectal resection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically proven new case of rectal cancer with the lower border within 15 cm from anal verge Age >18 years Informed consent obtained American Society of Anesthesiologist class 1-3 No contraindication to laparoscopic surgery Acceptable operating risk Exclusion Criteria: Locally advanced fixed tumor with the need for exenterative surgery Severe cardiac or pulmonary comorbidity rendering pneumoperitoneum hazardous Multiple previous operations with the anticipation of dense peritoneal adhesions No informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 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<br>robotic assisted rectal resection | Procedure: robotic assisted rectal resection<br>* robotic assisted rectal resection<br>|
| Active Comparator: laparoscopic<br>laparoscopic rectal resection | Procedure: laparoscopic rectal resection<br>* laparoscopic rectal resection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bladder function | Urodynamic Questionnaire | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tumor status | recurrence and survival | One year | 
| Quality of life | Questionnaire | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rectal cancer