The hysteroscopic morcellator versus the bipolar resectoscope for removal of submucous myomas: a randomized controlled trial.

Completed

• Conditions: 10046828; 10038595; benign tumour of the womb; submucous myoma

• Registration Number: NL-OMON37929
• Lead Sponsor: Catharina-ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 37

Inclusion Criteria

Patients with one or more intrauterine myoma(s) with a diameter <= 3 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:
• Myomas with a diameter > 3 cm (Note: Myomas > 3 cm are treated with
resectoscopy)
• Type 2 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Installation and operation 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>