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Robot geassisteerde microchirurgie in patiënten met zenuw schade in de vinger: een haalbaarheidsstudie

Robotic-assisted microsurgery in patients with digital nerve injuries; a feasibility study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25767
Enrollment
10
Registered
2018-02-07
Start date
2018-05-01
Completion date
Unknown
Last updated
2024-06-11

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

Conditions

microsurgery, digital nerve repair

Interventions

robotic-assisted anastomose of damaged nerve

Sponsors

Maastricht University Medical Center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - 18 years of age or older; - Traumatic digital nerve injury to one or more fingers; - Dutch resident (due to follow-up); - Time from trauma to presentation at the hospital is less than 24 hours.

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Amputation of an injured finger for which replantation is indicated - Previous injury or operation of the damaged nerve, or brachial plexus damage; - Crush injuries; - Additional fractures at the nerve injury site; - Current substance abuse; - Unable to finish follow-up for any reason.

Design outcomes

Primary

MeasureTime frame
The primary objective is to study the applicability of robotic-assisted microsurgery in DNR after trauma. The primary outcome is the quality of the anastomosis using 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; - Adverse events, complications and robotic errors peri-operatively; - Post-operative complications and adverse events; - Surgeon’s satisfaction with the technique applied; - Patient’s satisfaction with the surgery procedure; - Recovery of sensation in the injured nerve; - Function of the hand over time.

Contacts

Public ContactA. Scharmga

MUMC

andrea.scharmga@mumc.nl0031 43 3875496

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)