The hysteroscopic morcellator versus the bipolar resectoscope for removal of larger intrauterine polyps: a randomized controlled trial.
Completed
- Conditions
- endometrial polypswelling of the inner lining of the womb1003859510046828
- Registration Number
- NL-OMON38073
- Lead Sponsor
- Catharina-ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 37
Inclusion Criteria
Patients with one or more intrauterine polyp(s) with a diameter >= 1 cm as seen on ultrasound, confirmed by saline infusion sonography and/or ambulant diagnostic hysteroscopy who are planned for hysteroscopic surgery.
Exclusion Criteria
Patients with:
• Only polyps < 1cm (Note: intrauterine polyps < 1 cm are
treated in an ambulatory setting).
• 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.
• With a contra-indication for operative hysteroscopy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Installation and operating time. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Comparing data on peri- and post operative complications (e.g. fluid deficit,<br /><br>conversion rates, perforation, burns, postoperative infection), availability of<br /><br>tissue for pathology analysis and pathology results, and efficiency at 6 weeks<br /><br>follow-up. </p><br>