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

Withdrawn

Conditions: amputated finger
10003184

Registration Number: NL-OMON48976

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 5

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective is to study the applicability of robotic-assisted<br /><br>microsurgery in replantation of amputated digits due to trauma. The primary<br /><br>outcome will be the quality of the anastomoses using Structured Assessment of<br /><br>Microsurgery Skills (SAMS). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To provide important surgical and technical information, and to collect patient<br /><br>and surgeon satisfaction, the following secondary outcome measures are gathered:<br /><br>- Survival of the replanted digits;<br /><br>- Duration of surgery;<br /><br>- Adverse events, complications and robotic errors peri-operatively;<br /><br>- Post-operative complications and adverse events;<br /><br>- Surgeons satisfaction with the technique applied;<br /><br>- Patients satisfaction with the surgery procedure;<br /><br>- Function of the hand over time. </p><br>