No registrations found.
ID
Source
Brief title
Health condition
- polyp
- hysteroscopy
- Minimally Invasive Surgical Procedures
Sponsors and support
Ghent University Hospital
Intervention
Outcome measures
Primary outcome
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 outcome
Secondary Objective(s): Comparing data on procedure time, 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).
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. 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.
Study objective
To compare the resection speed of two different devices for removal of polyps (≥8mm - ≤20 mm) in terms of efficiency and complications.
Study design
- 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
Intervention
-Group 1: removal of intrauterine polyps with Truclear hysteroscopic morcellator
-Group 2: removal of intrauterine polyps with Resectr hysteroscopic morcellator
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
- endometrial polyps largest diameter ≥8mm - ≤20 mm
- intrauterine polyps confirmed by ultrasound, saline infusion sonography and/or ambulant diagnostic hysteroscopy
Exclusion criteria
• 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
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 | NL6922 |
| NTR-old | NTR7118 |
| Other | Catharina Hospital Eindhoven : EC/2017/1576 |