The Hysteroscopic Morcellator (HM).
Conditions
Large Intrauterine Polyps - Smaller Type 0 and 1 Myomas - Residual Placental Tissue
Conditions: official terms
Myoma - Polyps - Uterine Neoplasms
Conditions: Keywords
intrauterine polyps, myomas, residual placental tissue
Study Type
Interventional
Study Phase
Phase 4
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Intervention
Name: Hysteroscopic morcellator Type: Procedure
Name: Resectoscope Type: Procedure
Overall Status
Recruiting
Summary
Rationale:

The hysteroscopic morcellator (HM) is a novel technique for removal of intrauterine polyps, myomas and placental tissue. It withholds some technical advantages over resectoscopy. Previous data suggest that it's a faster technique than the latter, and shows that it has a low complication rate.

Objective:

To compare the HM to bipolar resectoscopy for removal of:

1) large intrauterine polyps, 2) smaller type 0 and 1 myomas, 3) residual placental tissue, in terms of efficiency and complications.

Study design: Single blind, randomized controlled multicenter trial.

Study population: Women aged over 18 years old with:

1) large (≥ 1 cm) intrauterine polyps, 2) smaller (≤ 3 cm) type 0 or 1 myomas, 3) residual placental tissue, who are planned for hysteroscopic removal.

Intervention:

Patients are randomized between removal with the HM or the bipolar resectoscope.

Main study parameters/endpoints:

Installation and operating time.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

Women who are referred to our polyclinic will be seen on a first visit, and, according to the standard work-up, an ultrasound will be performed when intrauterine pathology is suspected. To confirm the diagnosis a saline infusion sonography (SIS) and/or ambulant diagnostic hysteroscopy will be performed consequently. Once the diagnosis is confirmed and surgery is planned, women will be asked whether they want to take part in this study. At this moment, both techniques are used in our hospitals and the choice of treatment depends on the preference of the gynaecologist. All women will be treated with operative hysteroscopy in a daycare setting according to the standard of care, only now randomized between the two techniques. A standard postoperative visit with ultrasound examination and/or ambulant diagnostic hysteroscopy is scheduled 6 weeks later. Late postoperative complications and complaints are recorded.

It is expected that the HM beholds some advantages over the bipolar resectoscope such as shorter operating time and less complications (e.g. risk of perforation, current and fluid related complications). Previous data do not demonstrate any additional risks related to the use of the HM. Moreover we will check whether the HM has a lower risk of intrauterine adhesion formation, as this might influence patient's fertility.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
Criteria: 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.
Locations
Ghent University Hospital
Ghent, Belgium
Status: Recruiting
Contact: Steven Weyers, MD, PhD - Steven.Weyers@ugent.be
Catharina Hospital Eindhoven
Eindhoven, Netherlands
Status: Recruiting
Contact: Benedictus C Schoot, MD, PhD
Start Date
May 2011
Completion Date
September 2015
Sponsors
University Hospital, Ghent
Source
University Hospital, Ghent
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page