No registrations found.
ID
Source
Brief title
Health condition
Free flap, reconstruction, lower extremity, microsurgery
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
To provide important surgical and technical information, and to collect patient and surgeon satisfaction, the following secondary outcome measures are gathered:
• Duration of surgery (duration of the anastomosis and total surgery duration)
• Intra-operative and post-operative complications
• Surgical errors during the operation
• Surgeon’s satisfaction with the applied technique (VAS score)
• Flap success rate, reoperations, complications
• Patients’ satisfaction with the procedure (VAS score)
• Patient’s functional ability
Background summary
Lower extremity reconstruction is a field of plastic surgery that aims to restoring/maintaining limb function as well as ensuring optimal cosmetic outcomes. Recent advances in plastic surgical technique as well as the introduction of microvascular free tissue transfer has revolutionized this field, allowing the salvage of limbs that would have otherwise been amputated. Free tissue transfer is often needed when there is significant soft tissue loss with exposed bone, tendon, and blood vessels. Currently this operation is done by hand, were the hand is the limiting factor performing this technique. In cooperation with the Technical University in Eindhoven, and Maastricht University Medical Center, a new robotic platform has been developed. The primary objective of this study is to demonstrate the clinically applicable use of robotic-assistance in lower extremity free-flap reconstruction.
Study objective
A newly, dedicated robotic system for (super)microsurgery can increase efficiency and precison of microsurgical skills.
Study design
Primary and secondary outcomes will be assessed during (and after) surgery.
Intervention
Robotic-assisted anastomose of the artery/veins/nerves of the free flap to reconstruction site
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.
- Patients younger than 18 years of age
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6872 |
| NTR-old | NTR7050 |
| CCMO | NL64506.068.17 |
| OMON | NL-OMON54625 |