A newly, dedicated robotic system for (super)microsurgery can increase efficiency and precison of microsurgical skills
Bron
Verkorte titel
Aandoening
Robotic-assistance in replantation of an amputated digit after trauma
Ondersteuning
Onderzoeksproduct en/of interventie
Geen registraties gevonden.
Uitkomstmaten
Primaire uitkomstmaten
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).
Achtergrond van het onderzoek
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. Currently it is nearly impossible to repair veins and/or nerves in zone 1 (Tamai classification) amputations, hence there might be a place for a microsurgical robot. As it filters out the physiological tremor of the surgeon, it can be 10 times more precise than manual surgery. The purpose of this study is to investigate whether robot-assisted microsurgery is safe and if the use of the robot is beneficial.
Doel van het onderzoek
A newly, dedicated robotic system for (super)microsurgery can increase efficiency and precison of microsurgical skills
Onderzoeksopzet
Primary and secondary outcomes will be assessed during (and after) surgery.
Onderzoeksproduct en/of interventie
Robotic-assisted anastomose during replantation of amputated digit after trauma
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Toelichting
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL6873 |
NTR-old | NTR7051 |
CCMO | NL64164.068.17 |