Nowadays, the hysteroscopic morcellator (HM) is a widely used technique for removal of intrauterine polyps. Various mechanical, motor-driven tissue removal systems are used in clinical setting (Truclear; Medtronic, Minneapolis Minnesota, MyoSure;…
ID
Bron
Verkorte titel
Aandoening
- polyp
- hysteroscopy
- Minimally Invasive Surgical Procedures
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
To compare the resection speed of two different devices for removal of large polyps (larger than 8mm up to 20mm ) in terms of efficiency and complications.
Doel van het onderzoek
Nowadays, the hysteroscopic morcellator (HM) is a widely used technique for removal of intrauterine polyps. Various mechanical, motor-driven tissue removal systems are used in clinical setting (Truclear; Medtronic, Minneapolis Minnesota, MyoSure; Hologic, Bedford, MA and Bigatti;Karl Storz Tuttlingen, Germany). Recently, a new mechanical, hand-driven device was launched (Resectr®; Boston Scientifc, Marlborough, MA). It has advantages due to the simplicity and low costs. Furthermore, in vitro testing shows similar resection speed as the motorized device.
Onderzoeksopzet
-Screening: women wih an ultrasound suggestive for intrauterine polyps
-saline infusion sonography or diagnostic hysteroscopy confirm diagnosis of polyp larger than 8mm
-Randomisation (Truclear or Resectr) and removal of polyp
-Follow-up visit 6 weeks post-op with ultrasound
Onderzoeksproduct en/of interventie
Patients are randomized between removal with the HM using Truclear and the hand driven device Resectr® 9.0 french (fr).
Algemeen / deelnemers
Wetenschappers
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
-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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• 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
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6908 |
| NTR-old | NTR7103 |
| Ander register | Ethische comité : EC/2017/1576 |