Multicenter, randomized, controlled trial comparing complication rates of open and closed implantation strategies for insertion of a totally implantable venous access port (TIVAP) in oncological patients
Not Applicable
- Conditions
- OPS 5-399.5 - implantation and change of a permanent venous catheter (e.g. for chemotherapy or analgesiaJ93Pneumothorax
- Registration Number
- DRKS00004900
- Lead Sponsor
- Klinik für Allgemein,- Viszeral,- und Transplantationschirurgie, Chirurgische Universitätsklinik Heidelberg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 1205
Inclusion Criteria
1.Patient with oncological disease
2.scheduled for elective implantation of TIVAP
3.primary implantation on the designated side
4.Ability of subject to understand character and individual consequences of the clinical trial
5.Written informed consent
Exclusion Criteria
1.participation in another clinical trial which could interfere with the primary endpoint of this study
2.impaired mental state or language problems
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Frequency of pneumo-/hemothorax after TIVAP implantation diagnosed by means of a chest x-ray on the day of operation. Telephone interview on postoperative day 30
- Secondary Outcome Measures
Name Time Method - Primary success rates<br>- quality of life (EQ 5-D)<br>- duration of intervention<br>- mortality and morbidity until day 30. <br><br>Assessment on day of operation and standardized telephone interview on day 30 post-OP