No registrations found.
ID
Source
Brief title
Health condition
- polyp
- hysteroscopy
- Minimally Invasive Surgical Procedures
Sponsors and support
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 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
To compare the resection speed of two different devices for removal of large polyps (larger than 8mm up to 20mm ) in terms of efficiency and complications.
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.
Study design
-Screening: women wih an ultrasound suggestive for intrauterine polyps
-saline infusion sonography or diagnostic hysteroscopy confirm diagnosis of polyp larger than 8mm
-Randomisation (Truclear or Resectr) and removal of polyp
-Follow-up visit 6 weeks post-op with ultrasound
Intervention
Patients are randomized between removal with the HM using Truclear and the hand driven device Resectr® 9.0 french (fr).
Inclusion criteria
-Women of any ethnic background aged min. 18 years, attending our outpatient clinic with an intrauterine polyp
-Patients with one or more intrauterine polyps (larger than or equal to 8 mm up to 20mm) as seen on ultrasound, confirmed by saline infusion sonography and/or ambulant diagnostic hysteroscopy who are planned for hysteroscopic surgery.
Exclusion criteria
• Polyps smaller than 8 mm
• Polyps 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
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 | NL6908 |
| NTR-old | NTR7103 |
| Other | Ethische comité : EC/2017/1576 |