Robotic-assisted microsurgical free flap reconstruction of the lower extremity; a feasibility study
Recruiting
- Conditions
- free flap reconstruction of the lower extremity10003184
- Registration Number
- NL-OMON54625
- Lead Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
Any patient (>18 years or older) with an indication of lower extremity
free-flap reconstruction.
Exclusion Criteria
- Indication of more than one free flap
- Unable to provide informed consent (i.e. mentally unwell)
- Individual may not complete follow up for any reason.
- Patients younger than 18 years of age
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome is the quality of the anastomosis using Structured<br /><br>Assessment of Microsurgery Skills (SAMS). </p><br>
- Secondary Outcome Measures
Name Time Method <p>To provide important surgical and technical information, and to collect patient<br /><br>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</p><br>