Robotic-assisted microsurgery in digital replantation in patients with traumatic digital amputation; a feasibility study

Robotic-assisted microsurgery in digital replantation in patients with traumatic digital amputation; a feasibility study - Robotic-assisted microsurgery in digital replantation

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON56234

Enrollment

Registered

2023-10-06

Start date

2024-05-19

Completion date

Unknown

Last updated

2025-08-18

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

Conditions

amputated finger

Interventions

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

Eligibility

Age

18 Years to 99 Years

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 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

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 outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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; - Surgeons satisfaction with the technique applied; - Patients satisfaction with the surgery procedure; - Function of the hand over time.	—

Measure

Time frame

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.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)