The Hysteroscopic Morcellator (HM).

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

253 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2018-07-01

Brief Summary

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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.

After completion of the RCT, an observational study is planned considering pregnancies subsequent to the hysteroscopic procedure.

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Detailed Description

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Conditions

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Large Intrauterine Polyps Smaller Type 0 and 1 Myomas Residual Placental Tissue

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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hysteroscopic morcellator

Women, randomized into getting a treatment with the hysteroscopic morcellator.

Group Type EXPERIMENTAL

Hysteroscopic morcellator

Intervention Type PROCEDURE

Morcellation will be performed with the HM (TRUCLEAR, Smith \& Nephew, Andover, USA). The rotary blade is used for polypectomy and removal of residual placental tissue; the reciprocating blade is used for myomectomy. The blade has a window-opening at the end with cutting edges through which tissue is aspirated by means of a vacuum source. The removed tissue is discharged through the device, collected in a pouch and made available for pathology analysis.

Resectoscope

Women, randomized into getting a treatment with the resectoscope.

Group Type ACTIVE_COMPARATOR

Resectoscope

Intervention Type PROCEDURE

Resectoscopy will be performed with a rigid 8.5 mm bipolar resectoscope (Karl Storz GmbH, Tuttlingen, Germany), equipped with a 0 or 30 degree optic. Normal saline is used for distension and irrigation of the uterine cavity. Fluid balance is closely monitored using a Hystero pump (Richard Wolf GmbH, Knittlingen, Germany) or Hysteromat pump (Karl Storz GmbH, Tuttlingen, Germany).

Interventions

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Hysteroscopic morcellator

Morcellation will be performed with the HM (TRUCLEAR, Smith \& Nephew, Andover, USA). The rotary blade is used for polypectomy and removal of residual placental tissue; the reciprocating blade is used for myomectomy. The blade has a window-opening at the end with cutting edges through which tissue is aspirated by means of a vacuum source. The removed tissue is discharged through the device, collected in a pouch and made available for pathology analysis.

Intervention Type PROCEDURE

Resectoscope

Resectoscopy will be performed with a rigid 8.5 mm bipolar resectoscope (Karl Storz GmbH, Tuttlingen, Germany), equipped with a 0 or 30 degree optic. Normal saline is used for distension and irrigation of the uterine cavity. Fluid balance is closely monitored using a Hystero pump (Richard Wolf GmbH, Knittlingen, Germany) or Hysteromat pump (Karl Storz GmbH, Tuttlingen, Germany).

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No