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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON37929
Enrollment
37
Registered
2011-01-18
Start date
2011-04-20
Completion date
Unknown
Last updated
2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

benign tumour of the womb submucous myoma

Interventions

Sponsors

Catharina-ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with one or more intrauterine myoma(s) with a diameter

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Installation and operation time.

Secondary

MeasureTime frame
Comparing data on peri- and post operative complications (e.g. fluid deficit, conversion rates, perforation, burns, postoperative infection), availability of tissue for pathology analysis and pathology results, and efficiency at 6 weeks follow-up.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)