To assess the applicability of robotic-assisted microsurgery in replantation of amputated digits due to trauma.
ID
Source
Brief title
Condition
- Vascular therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective is to study the applicability of robotic-assisted
microsurgery in replantation of amputated digits due to trauma. The primary
outcome will be the quality of the anastomoses 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:
- Survival of the replanted digits;
- 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;
- Function of the hand over time.
Background summary
Microsurgery requires great skill and is limited by the precision and
physiological tremor of the operating surgeon. Robotic-assistance could be of
benefit in microsurgical procedures by increasing the precision during the
operation. Currently we are performing robotic-assisted microsurgery in
lymphatico-venular anastomosis (LVA), with the next step being expanding the
use of the robotic-assisted microsurgery to replantation of amputated digits.
Digital replantation requires great precision as very small vessels and nerves
have to be repaired.
Study objective
To assess the applicability of robotic-assisted microsurgery in replantation of
amputated digits due to trauma.
Study design
A prospective feasibility study assesses 5 patients with traumatic amputation
of one or more digits to undergo robot assisted repair. The primary outcome
will be the quality of the anastomoses using Structured Assessment of
Microsurgery Skills (SAMS). Secondary outcome measures include survival,
duration of the surgery, adverse events, complications peri-operatively, the
surgeon*s satisfaction and the Michigan Hand Outcomes Questionnaire (MHQ).
Intervention
Large part of the surgery follows the normal procedure. The robotic-assisted
part of operation is as follows:
After preparation of the nerves, arteries and veins, the robot will be used to
reconnect these structures with robotic assistance. It is up to the treating
surgeon to determine the amount of arteries and veins that will be reconnected
to get optimal perfusion of the replanted digit.
The operating surgeon will decide which vessels and nerves will be reconnected
and how many of these repairs will be done with robotic-assistance. Patient
characteristics, the quality of the traumatised tissues, ischaemia time and
operating time and patient position will be important factors in this decision.
Study burden and risks
A similar study in robotic- assisted replantation of an amputated digit has
not yet been performed with this first robotic platform for microsurgery.
However, the robot has been extensively tested in the laboratory and on
animals, and currently the robot is used for robotic-assisted LVA in a pilot
study. Participating surgeons will be sufficiently trained to use the robot.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
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 amputation of one or more digits;
- Dutch resident (due to follow-up);
- Time from trauma to presentation is less than 6 hours;
- Amputated finger is feasible for replantation;
- Patient request replantation over *simple* wound repair with revision
amputation.
Exclusion criteria
In het Engels
A potential subject who meets any of the following criteria will be
excluded from participation in this study:
- Additional significant trauma that dictates other treatment priorities
- Patient is not able to understand the study and consent for the operation
- Current substance abuse;
- Inability to replant the digit for any reason;
- Unable to finish follow-up for any reason.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| CCMO | NL81387.068.22 |