The hand driven hysteroscopic tissue removal system (Resectr 9Fr) versus motor driven hysteroscopic tissue removal system (Truclear) for removal of polyps: A randomized controlled trail.
Completed
- Conditions
- benign uterine growthpolyp10013326
- Registration Number
- NL-OMON55576
- Lead Sponsor
- Z Gent
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 80
Inclusion Criteria
- Patients with one or more intrauterine polyps (largest diameter >=8 mm - <=
20mm).as seen on ultrasound, confirmed by saline infusion sonography and/or
ambulant diagnostic hysteroscopy
- Planned for hysteroscopic surgery.
Exclusion Criteria
Patients with:
• Polyps <8 mm or > 20mm
• 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Installation time and resection/ operating time.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Fluid deficit, conversion rates, peri- and postoperative complications,<br /><br>availability of tissue for pathology, persistence of symptoms (e.g.<br /><br>menorrhagia) and/or intrauterine abnormalities at 6 weeks follow-up, pain<br /><br>scores and evaluation of surgeons convenience during procedures.</p><br>