To compare the resection speed of two different devices for removal of polyps (≥8mm - ≤20 mm) in terms of efficiency and complications.
ID
Bron
Verkorte titel
Aandoening
- polyp
- hysteroscopy
- Minimally Invasive Surgical Procedures
Ondersteuning
Ghent University Hospital
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
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. This study wants to compare the resection speed of two different devices for removal of polyps (≥8mm, ≤20 mm) in terms of efficiency and complications.
Doel van het onderzoek
To compare the resection speed of two different devices for removal of polyps (≥8mm - ≤20 mm) in terms of efficiency and complications.
Onderzoeksopzet
- diagnosis intrauterine polyps
- confirmation by ultrasound, saline infusion sonography and/or ambulant diagnostic hysteroscopy
- inclusion in study
- randomisation and removal of polyps
- 6 weeks post operation: follow-up
Onderzoeksproduct en/of interventie
-Group 1: removal of intrauterine polyps with Truclear hysteroscopic morcellator
-Group 2: removal of intrauterine polyps with Resectr hysteroscopic morcellator
Publiek
Dick Schoot
C. Heymanslaan 10
Gent 9000
Belgium
+31 6 51 54 70 41
Dick@schoot.com
Wetenschappelijk
Dick Schoot
C. Heymanslaan 10
Gent 9000
Belgium
+31 6 51 54 70 41
Dick@schoot.com
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- endometrial polyps largest diameter ≥8mm - ≤20 mm
- intrauterine polyps confirmed by ultrasound, saline infusion sonography and/or ambulant diagnostic hysteroscopy
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• Polyps largest diameter smaller than 8 mm
• Polyps largest diameter 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
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6922 |
| NTR-old | NTR7118 |
| Ander register | Catharina Hospital Eindhoven : EC/2017/1576 |