The hand driven hysteroscopic tissue removal system (Resectr® 9.0 fr) versus motor driven hysteroscopic tissue removal system (Truclear) for removal of polyps: a randomized controlled trial.
- Conditions
- - polyp- hysteroscopy- Minimally Invasive Surgical Procedures
- Registration Number
- NL-OMON25363
- Lead Sponsor
- Stichting research foundation Gynaecology, represented by Benedictus Christiaan Schoot
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 120
Inclusion Criteria
Women of any ethnic background aged min. 18 years, attending our outpatient clinic with an intrauterine polyp
Exclusion Criteria
•Polyps smaller than 8 mm
•Polyps larger than 20 mm
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Objective: Comparing installation and operating time between the Truclear HM device and the Resectr® 9.0 fr HM device for removal of intrauterine large polyps.
- Secondary Outcome Measures
Name Time Method Secondary Objective(s): Comparing data on peri- and postoperative complications (e.g. fluid deficit, conversion rates, perforation), postoperative availability of tissue for pathology analysis and pathology diagnosis, pain scores, evaluation of surgeons convenience during procedures and efficiency (completeness of resection and persistence of symptoms or abnormalities at 6 weeks follow-up).