Retrospective Study on Colorectal Robotic Surgery Results Obtained Using a New Robotic Platform
- Conditions
- Colorectal Surgery
- Registration Number
- NCT03130530
- Lead Sponsor
- Istituto Clinico Humanitas
- Brief Summary
The ALF-X (Advanced Laparoscopy through Force reflection) Robotic Surgery System is a medical device that is available for distribution in the EU (European Union) under CE Mark for use in general surgery, thoracic surgery, gynecological surgery and urological surgery. The main research question is to assess, from a retrospective poit of view, the safety and feasibility of this new robotic platform in the colorectal surgery.
- Detailed Description
The rationale of this study is to investigate the perioperative and the short term perioperative outcomes of this new robotic Platform in minimally invasive colorectal surgery. Tha ALF-X utilizes fully reusable along with haptic feedback and an innovative vision control system.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
- Patients affected by colorectal disease (benign or malignant) having undergone surgery using ALF-X platform
- none
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation adverse events from the surgery up to 30 days after the surgery Adverse events occurred during the surgery and during the 30 days after the surgery evaluated using Clavien-Dindo Classification, conversion rate to traditional laparoscopy or open surgery
- Secondary Outcome Measures
Name Time Method Setup for surgery - collision rate from to the start to the end of the surgery Registration and calculation of the collision rate
Setup for surgery - reduced mobility from to the start to the end of the surgery Registration and calculation of the reduced mobility of the tools
Adverse events Up to 30 days post-surgery Number of adverse events
Duration of hospitalisation from surgery to hospital discharge, up to 30 days Duration of hospitalisation
Duration of surgery from to the start to the end of the surgery Duration of surgery
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