A randomized, controlled trial comparing the use of the Endoflator 50® (KARL STORZ SE & CO. KG) to not preheated optic
Not Applicable
- Conditions
- All patients had a planned laparoscopy, most common indications were Uterine myoma, Endometriosis and various gynecological malignancies
- Registration Number
- DRKS00033789
- Lead Sponsor
- niversitätsklinikum des Saarlandes, Klinik für Frauenheilkunde, Geburtshilfe und Reproduktionsmedizin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 73
Inclusion Criteria
• informed consent
• Age over 18 years
• Indication for laparoscopy
• ASA Risk Classification I-II
Exclusion Criteria
• No informed consent
• Pregnancy. This is validated preoperatively via a pregnancy test (urine), not older than 24 hours
• Allergies to the anti-fog agents used
• Phemoperitoneum or severe ascites
• ASA = III
• Duration of operation less than 30 min
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method primary outcome is the severity of fogging of the laparoscopic lens after 1, 10 and 30 min into surgery using a visual analogue scale, the fogging is evaluated by two independent, blinded doctors. This severity is classified on a 10-point visual scale, with 0 representing a completely clear view and 10 representing the greatest possible fogging
- Secondary Outcome Measures
Name Time Method