Robot geassisteerde microchirurgische vrije lap reconstructie van de onderste extremiteit: een haalbaarheidsstudie
- Conditions
- Free flap, reconstruction, lower extremity, microsurgery
- Registration Number
- NL-OMON22584
- Lead Sponsor
- Maastricht University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 10
Inclusion Criteria
Any patient (>18 years or older) with an indication of lower extremity free-flap reconstruction.
Exclusion Criteria
-Unable to provide informed consent (i.e. mentally unwell)
-Individual may not complete follow up for any reason.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of this study is to demonstrate the clinically applicable use of robot-assistance in lower extremity free-flap reconstruction. The primary outcome is the quality of the anastomosis using Structured Assessment of Microsurgery Skills (SAMS).
- Secondary Outcome Measures
Name Time Method To provide important surgical and technical information, and to collect patient and surgeon satisfaction, the following secondary outcome measures are gathered:<br /><br>•Duration of surgery (duration of the anastomosis and total surgery duration)<br /><br>•Intra-operative and post-operative complications<br /><br>•Surgical errors during the operation<br /><br>•Surgeon’s satisfaction with the applied technique (VAS score)<br /><br>•Flap success rate, reoperations, complications<br /><br>•Patients’ satisfaction with the procedure (VAS score)<br /><br>•Patient’s functional ability<br>