Comparison of hand or motor driven hysteroscopic removal systems
- Conditions
- - polyp- hysteroscopy- Minimally Invasive Surgical Procedures
- Registration Number
- NL-OMON21102
- Lead Sponsor
- Catharina Hospital EindhovenGhent University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 140
Inclusion Criteria
endometrial polyps largest diameter =8mm - =20 mm
- intrauterine polyps confirmed by ultrasound, saline infusion sonography and/or ambulant diagnostic hysteroscopy
Exclusion Criteria
•Polyps largest diameter smaller than 8 mm
•Polyps largest diameter larger than 20 mm
•Myomas
•Visual or pathological (e.g. on biopsy) evidence of malignancy
preoperatively or at the time of operation
•Untreated cervical stenosis making safe access for operative hysteroscopy
impossible as diagnosed preoperatively or at the time of operation
•A contra-indication for operative hysteroscopy
•Significant language barrier
•Pregnant women
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 procedure time, 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).