The Hysteroscopic Morcellator (HM). (HM)

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.

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.

Study Overview

• Status: Completed
• Conditions: Large Intrauterine Polyps; Smaller Type 0 and 1 Myomas; Residual Placental Tissue
• Intervention / Treatment: Procedure: Hysteroscopic morcellator; Procedure: Resectoscope

• Study Type: Interventional
• Enrollment (Actual): 253
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • Ghent University Hospital
• Netherlands
  • Eindhoven, Netherlands, 5602 ZA
    • Catharina Hospital Eindhoven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: hysteroscopic morcellator; Women, randomized into getting a treatment with the hysteroscopic morcellator.	Procedure: 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.
Active Comparator: Resectoscope; Women, randomized into getting a treatment with the resectoscope.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Installation time and operating time.	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.	the length of the operation
Check for adhesions during follow-up.	Ambulant diagnostic hysteroscopy is performed at 6 weeks postoperative follow-up.	After 6 weeks, during follow-up visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fluid deficit	Fluid deficit in both procedures is the result of subtracting the outflow volumes from the inflow volumes as measured by the pump.	during the length of the operation
complications and complaints	During the postoperative hospital stay blood samples looking for electrolyte imbalances will only be taken when excessive fluid absorption is suspected based on fluid deficit (> 2500 mL for normal saline) and/or clinical symptoms. At 6 weeks postoperatively a standard visit is scheduled. Complications and complaints are recorded, and ultrasound is performed.	between operation until 6 weeks follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pregnancy rate	number of pregnancies / number of women wishing to conceive	between the hysteroscopic removal of residual placental tissue and the first clinical pregnancy up to 7 years of follow-up
Pregnancy outcome	Pregnancy outcome (biochemical / EUG / miscarriage / fetal demise / live birth)	the first pregnancy subsequent to the hysteroscopic removal of residual placental tissue up to 7 years of follow-up
Pregnancy complication	Pregnancy complication (vaginal blood loss / preterm contractions / PPROM / pregnancy induced hypertension / preeclampsia / eclampsia / uterine rupture)	the first pregnancy subsequent to the hysteroscopic removal of residual placental tissue up to 7 years of follow-up

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Investigators: Principal Investigator: Steven Weyers, MD, PhD, University Hospital, Ghent

Publications and helpful links

General Publications

• Hamerlynck TW, Schoot BC, van Vliet HA, Weyers S. Removal of Endometrial Polyps: Hysteroscopic Morcellation versus Bipolar Resectoscopy, A Randomized Trial. J Minim Invasive Gynecol. 2015 Nov-Dec;22(7):1237-43. doi: 10.1016/j.jmig.2015.07.006. Epub 2015 Jul 17.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): July 1, 2018
• Study Completion (Actual): July 1, 2018

Study Registration Dates

• First Submitted: February 15, 2012
• First Submitted That Met QC Criteria: February 17, 2012
• First Posted (Estimate): February 23, 2012

Study Record Updates

• Last Update Posted (Actual): February 4, 2021
• Last Update Submitted That Met QC Criteria: February 3, 2021
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: intrauterine polyps; myomas; residual placental tissue
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Female; Uterine Diseases; Pathological Conditions, Anatomical; Neoplasms, Muscle Tissue; Polyps; Myoma; Uterine Neoplasms
• Other Study ID Numbers: 2011/679