No registrations found.
ID
Source
Brief title
Health condition
- polyp
- hysteroscopy
- Minimally Invasive Surgical Procedures
Sponsors and support
Department of Obstetrics and Gynaecology
Catharina Hospital Eindhoven
Intervention
Outcome measures
Primary outcome
Installation and resection time (of the largest polyp)
Secondary outcome
o Surgeon’s convenience on a 5-point Likert scale
o Patient’s pain and satisfaction score on a 5-point Likert scale
o Intra- and postoperative complications (fluid deficit, blood loss (≥ 500ml), uterine perforation, infection)
o Completeness of resection (separation and extraction of all visible polyp tissue)
o Short term effectiveness (persistence of symptoms at 6 week follow-up)
o Postoperative availability of tissue for pathology analysis and pathology diagnosis
Background summary
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.
Study objective
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.
Study design
- 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
Intervention
Hysteroscopic polypectomy using the hand driven tissue removal device Resectr® 5.0 fr. in an office setting without anesthesia
Dick Schoot
C. Heymanslaan 10
Gent 9000
Belgium
+31 6 51 54 70 41
Dick@schoot.com
Dick Schoot
C. Heymanslaan 10
Gent 9000
Belgium
+31 6 51 54 70 41
Dick@schoot.com
Inclusion criteria
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.
Exclusion criteria
• 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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6923 |
| NTR-old | NTR7119 |
| Other | Catharina Hospital : 2017/1577 |