Efficacy Study of Robotic Surgery for Rectal Cancer

Study Overview
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Brief Summary
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After introducing minimally invasive surgery, robotic surgery has been increasingly used in colorectal cancer. However, there is a few prospective study for robotic surgery. The aim of this trial is to evaluate the effectiveness and safety of robotic surgery in mid or low rectal cancer.

Detailed Description
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This study was designed as randomized phase II trial (laparoscopic versus robotic). The primary end point is quality of mesorectal excision.

Official Title
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Clinical Assessment of Laparoscopic and Robotic Surgery for Rectal Cancer - Randomized Phase II Trial

Conditions
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Rectal Neoplasm

Intervention / Treatment
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* Procedure: Robotic surgery
* Procedure: Laparoscopic surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: mid or low rectal cancer (within 9cm from anal verge) pathologically proven as adenocarcinoma written informed consent no severe functional disability in lung and heart Exclusion Criteria: invading adjacent organ distant metastasis (lung, liver, brain, bone, distant lymph nodes etc.) lateral pelvic lymph node metastasis Have severe concomitant disease that might limit compliance or completion of the protocol. Have any other malignancy that might impact 5-year survival or might be potentially confused with rectal cancer. If female, be pregnant or breast feeding. Hereditary colorectal cancer (HNPCC, FAP etc) emergency operation

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robotic surgery<br>Proctectomy using robot | Procedure: Robotic surgery<br>* Robotic assisted rectal resection<br>* Other names: da Vinci Surgical System;|
| Active Comparator: Laparoscopic surgery<br>Conventional laparoscopic rectal resection | Procedure: Laparoscopic surgery<br>* Laparoscopic assisted rectal resection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of mesorectal excision | Evaluating the quality of mesorectal excision in rectal specimen according to the criteria suggested by Nagtegaal ID, et al. (J Clin Oncol. 2002;20:1729-34) | 7days after surgery (Pathologic report) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-term postoperative outcome |  | Within postoperative 30 days | 
| Sexual and urinary function, Quality of life, Anorectal function | IIEF, FSFI, IPSS, EORTC C30, CR38, FISI, MSKCC bowel fuction tool, Manometry | Baseline, postop 3 weeks, 3months, 12 months, 24 months, 36 months | 
| Long-term outcome | 3 year disese-free survival | Postoperative 36 months | 

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