Primary Objective: Comparing installation and operating time between the Truclear HM device and the Resectr HM device for removal of intrauterine large polyps.Secondary Objective(s): Comparing data on peri- and post operative complications (e.g.…
ID
Source
Brief title
Condition
- Menstrual cycle and uterine bleeding disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Installation time and resection/ operating time.
Secondary outcome
Fluid deficit, conversion rates, peri- and postoperative complications,
availability of tissue for pathology, persistence of symptoms (e.g.
menorrhagia) and/or intrauterine abnormalities at 6 weeks follow-up, pain
scores and evaluation of surgeons convenience during procedures.
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.
Study objective
Primary Objective: Comparing installation and operating time between the
Truclear HM device and the Resectr HM device for removal of intrauterine large
polyps.
Secondary Objective(s): Comparing data on peri- and post operative
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).
Study design
Single-blind randomized controlled trial comparing the Truclear HM with Resectr
HM device in operative hysteroscopy. Patients are not aware of the technique
used. The duration of the study is estimated at 2 years based on operating data
of the last 4 years in our center. The study will be performed in the
Department of Gynecology in our university-affiliated teaching hospital,
Catharina Hospital Eindhoven, the Netherlands and in the department of OB GYN
UZ Gent Belgium
Intervention
Hystroscopisic tissue removal (polyp removal)
Study burden and risks
We do acknowledge certain disadvantages of the Resectr and Truclear. The
inability to coagulate bleeding vessels encountered during surgery might be a
disadvantage. However, so far, no significant intraoperative or postoperative
bleeding was documented. Secondly, both techniques cannot be used for the
treatment of submucous fibroids. However, in the work-up of operative
hysteroscopy polyps can clearly be diagnosed.
Corneel Heymanslaan 10
Gent 9000
BE
Corneel Heymanslaan 10
Gent 9000
BE
Listed location countries
Age
Inclusion criteria
- Patients with one or more intrauterine polyps (largest diameter >=8 mm - <=
20mm).as seen on ultrasound, confirmed by saline infusion sonography and/or
ambulant diagnostic hysteroscopy
- Planned for hysteroscopic surgery.
Exclusion criteria
Patients with:
• Polyps <8 mm or > 20mm
• 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
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| Other | Nederlands Trial Register (NL 6922) |
| CCMO | NL63142.100.18 |