None listed
Conditions
Interventions
Patients are randomized between removal with the HM using Truclear and the hand driven device Resectr® 9.0 french (fr).
Sponsors
Stichting research foundation Gynaecology, represented by Benedictus Christiaan Schoot
Eligibility
Inclusion criteria
Inclusion criteria: -Women of any ethnic background aged min. 18 years, attending our outpatient clinic with an intrauterine polyp -Patients with one or more intrauterine polyps (larger than or equal to 8 mm up to 20mm) as seen on ultrasound, confirmed by saline infusion sonography and/or ambulant diagnostic hysteroscopy who are planned for hysteroscopic surgery.
Exclusion criteria
Exclusion criteria: • Polyps smaller than 8 mm • Polyps 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary Objective(s): Comparing data on 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). | — |
Contacts
Public ContactDick Schoot
Outcome results
None listed