A prospective, multicenter clinical study to evaluate the safety profile of the FlexiSurge Adhesion Barrier for the prevention of intra-abdominal adhesion formation after laparotomy
Completed
- Conditions
- vorming van adhesies na buikchirurgieadhesion formationpostoperative adhesions
- Registration Number
- NL-OMON40303
- Lead Sponsor
- Medisse BV
- Brief Summary
Trial ended prematurely
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 5
Inclusion Criteria
elective colectomy
elective colectomy with temporary stoma placement, followed by elective stoma reversal
elective liver first surgery, followed by elective surgical colectomy
ASA score 1-3
Exclusion Criteria
previous surgery through abdominal incision
patients with a known history of adhesiolysis
BMI <=19 or >=35
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Evaluation of Adverse Events reported during the study </p><br>
- Secondary Outcome Measures
Name Time Method <p>Time to discharge; post discharge follow up; implant handling and macroscopical<br /><br>features of the FlexiSurge Adhesion Barrier; Incidence, severity and extent of<br /><br>the adhesions formed</p><br>