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ID
Source
Brief title
Health condition
microsurgery, digital nerve repair
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 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;
- 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.
Background summary
During microsurgical performances, the surgeon’s hands always have a small physiological tremor, which limits precision. Hence, to improve movement precision, robotic-assisted microsurgery might be of great importance. Currently we are performing robotic-assisted microsurgery in lymphatico-venular anastomosis, with the next step being expanding the use of the robotic-assisted microsurgery to digital nerve repairs.
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 damaged nerve
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
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
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 | NL6871 |
| NTR-old | NTR7049 |
| CCMO | NL64178.068.17 |
| OMON | NL-OMON54692 |