The primary objective of this study is to demonstrate the clinically applicable use of robotic-assistance in lower extremity free-flap reconstruction.
ID
Source
Brief title
Condition
- Vascular therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 in performing this technique. In
cooperation with the Technical University in Eindhoven (TuE) and Maastricht
University Medical Center (MUMC+), a new robotic-platform has been developed.
Study objective
The primary objective of this study is to demonstrate the clinically
applicable use of robotic-assistance in lower extremity free-flap
reconstruction.
Study design
A prospective study assesses ten patients who will undergo robotic-assisted
microsurgical free flap reconstruction of the lower extremity.
Intervention
A large part of the operation follows the normal procedure. During suturing of
the bloodvessels/nerves (anastomoses) robotic-assistance will be used.
Study burden and risks
A similar study has not yet been performed. However, the robot has been
extensively tested in the laboratory and on animals, and currently a pilot
study has started for lymphatico-venular anastomosis. Participating surgeons
will be sufficiently trained using the robot.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL64506.068.17 |
| OMON | NL-OMON22584 |