Pilot study of the safety and tolerance of preoperative melatonin application in patients undergoing major liver resection. - PORTA
Phase 1
- Conditions
- postoperative infectious complicationsICD classification code : T 81.4
- Registration Number
- EUCTR2006-005308-15-DE
- Lead Sponsor
- niversity Heidelberg, Department of General Surgery
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Male and femle patients with liver carcinoma intended for a elective partial liver resection (3 or more segments)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- patients < 18 and > 90 years old
- emergency
- Patients with severe organ-specific problems like liver or renal insufficiency and
acute pancreatitis
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Testing safety and tolerance of a single, präoperative dosis of Melatonin for patients undergoing large liver resections;Secondary Objective: Group size power calculation for the execution of a clinical efficiency study due to occurred infectious events in the present pilot study<br>;Primary end point(s): liver enzymes for the evaluation of pathophysiological situations/functions
- Secondary Outcome Measures
Name Time Method