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Robot geassisteerde microchirurgische vrije lap reconstructie van de onderste extremiteit: een haalbaarheidsstudie

Robotic-assisted microsurgical free flap reconstruction of the lower extrimity: a feasibility study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON22584
Enrollment
10
Registered
2018-02-07
Start date
2018-05-01
Completion date
Unknown
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Free flap, reconstruction, lower extremity, microsurgery

Interventions

Robotic-assisted anastomose of the artery/veins/nerves of the free flap to reconstruction site

Sponsors

Maastricht University Medical Center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Any patient (>18 years or older) with an indication of lower extremity free-flap reconstruction.

Exclusion criteria

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Contacts

Public ContactA. Scharmga

MUMC

andrea.scharmga@mumc.nl0031433875496

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)