The Hysteroscopic Morcellator Versus the Bipolar Resectoscope for Removal of Lager Intrauterine Polyps, Removal of Submucous Myomas and Removal of Residual Placental Tissue: a Randomized Controlled Trial.
18 Years
N/A
Female
Large Intrauterine Polyps, Smaller Type 0 and 1 Myomas, Residual Placental Tissue
Trial Information
The Hysteroscopic Morcellator Versus the Bipolar Resectoscope for Removal of Lager Intrauterine Polyps, Removal of Submucous Myomas and Removal of Residual Placental Tissue: a Randomized Controlled Trial.
Inclusion Criteria:
- Patients with one or more intrauterine polyp(s) with a diameter ≥ 1 cm as seen on
ultrasound, confirmed by saline infusion sonography and/or ambulant diagnostic
hysteroscopy who are planned for hysteroscopic surgery.
- Patients with one or more intrauterine myoma(s) with a diameter ≤ 3 cm as seen on
ultrasound, confirmed by saline infusion sonography and/or ambulant diagnostic
hysteroscopy who are planned for hysteroscopic surgery.
- Patients with residual placental tissue as seen by ambulant diagnostic hysteroscopy
who are planned for hysteroscopic surgery.
Exclusion Criteria:
- Only polyps < 1cm (Note: intrauterine polyps < 1 cm are treated in an ambulatory
setting).
- Myomas with a diameter > 3 cm (Note: Myomas > 3 cm are treated with resectoscopy)
- Type 2 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.
- With a contra-indication for operative hysteroscopy.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Outcome Measure:
Installation time and operating time.
Outcome Description:
Installation time is defined as the time to set up the hysteroscopic instrumentation ready for use (time from start of setting up the instrumentation to start resection / morcellation). Operating time is defined as the time starting visual introduction of the hysteroscope until the time at which the procedure is completed and the hysteroscope is removed definitely. Times will be measured with a stop watch by a trained nurse.
Outcome Time Frame:
the length of the operation
Safety Issue:
No
Principal Investigator
Steven Weyers, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Ghent University Hospital
Authority:
Belgium: Ethics Committee
Study ID:
2011/679
NCT ID:
NCT01537822
Start Date:
May 2011
Completion Date:
September 2014
Related Keywords:
- Large Intrauterine Polyps
- Smaller Type 0 and 1 Myomas
- Residual Placental Tissue
- intrauterine polyps
- myomas
- residual placental tissue
- Myoma
- Polyps
- Uterine Neoplasms
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