Hemostasis after radical prostatectomy through the usage of 4DryField® PH
Phase 4
Recruiting
- Conditions
- T81.0T81.4I89.8Infection following a procedure, not elsewhere classifiedHaemorrhage and haematoma complicating a procedure, not elsewhere classifiedOther specified noninfective disorders of lymphatic vessels and lymph nodes
- Registration Number
- DRKS00014754
- Lead Sponsor
- PlantTec Medical GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 200
Inclusion Criteria
Written consent to take part in the study, planned radical prostatectomy surgery (open as well as laparoscopic)
Exclusion Criteria
Known intolerance of starch or starch containing substances, existence of a clotting disorder
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method There are two primary endpoints: the time (in minutes) until hemostasis is reached and the total drainage volume until the drainage is removed.
- Secondary Outcome Measures
Name Time Method Secondary endpoints are the frequency of blood donations (as well as the respective mean total volume per patient) until discharge, the course of the hemoglobin and hematocrit concentrations within the first five days after surgery (this will only be evaluated for the patients which did not receive a blood donation because there values would be influenced by this), the frequency of the necessity to use additional electrocautery for hemostasis as well as the frequency of the following surgery-depending complications until the end of the study: anastomotic insufficiency, wound healing disturbances, infections, seromas, lymphoceles and hematomas.