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
Department of Obstetrics and Gynaecology
Catharina Hospital Eindhoven
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Installation and resection time (of the largest polyp)
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. The small 5.0 fr variant can be used in the outpatient setting. In this study the investigator wants to acquire information concerning the resection speed of the Resectr® 5.0 fr device for the removal of small polyps (mean diameter ≤ 8 mm) in terms of efficiency and complications.
Study design: Prospective multicenter trial.
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. The small 5.0 fr variant can be used in the outpatient setting.
Onderzoeksopzet
- diagnosis of intrauterine polyps
- confirmation by saline infusion sonography and/or diagnostic hysteroscopy
- inclusion in study
- hysteroscopic polypectomy using Resectr® 5.0 fr.
- 6 weeks after the operation: follow-up visit or telephone contact
Onderzoeksproduct en/of interventie
Hysteroscopic polypectomy using the hand driven tissue removal device Resectr® 5.0 fr. in an office setting without anesthesia
Algemeen / deelnemers
Dick Schoot
C. Heymanslaan 10
Gent 9000
Belgium
+31 6 51 54 70 41
Dick@schoot.com
Wetenschappers
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)
Patients of 18 years or older, with one or more intrauterine polyp (mean diameter 8mm or smaller) as seen on ultrasound, saline infusion sonography and/or ambulant diagnostic hysteroscopy who are planned for hysteroscopic surgery in an outpatient setting.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• Polyps > 8 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 | NL6923 |
| NTR-old | NTR7119 |
| Ander register | Catharina Hospital : 2017/1577 |