De Afhang Studie
Recruiting
- Conditions
- ower leg reconstructionFree flap
- Registration Number
- NL-OMON20011
- Lead Sponsor
- niversity Medical Center Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 130
Inclusion Criteria
Male or female
- Age between 18 and 99 years old
Exclusion Criteria
- Age under 18 years
- Co-morbidities that prevent the patient from being able to undergo a dangling protocol
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective is to assess whether a no dangling protocol is non-inferior to a<br>dangling protocol in terms of proportion of patients who experienced partial flaps loss which did not<br>require another free lap procedure at six months after surgery.
- Secondary Outcome Measures
Name Time Method - We hypothesize that there will be no difference in major complications at 6 months.<br /><br>- We would like to objectify the gaseous changes within the free flap during the<br>dangling protocol in a selective group of patients.<br /><br>- We will measure the physical functions at 3 and 6 months with the PROMIS and EQ-5D<br>questionnaires.<br /><br>- We hypothesize that there is no difference in the number of patients experiencing one<br>or more minor complications at three and six months post operative.<br /><br>- Investigate if there is a difference in the length of hospital stay between the two<br>groups.