The Hysteroscopic Morcellator (HM).

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University Hospital, Ghent
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01537822
First received: February 15, 2012
Last updated: January 29, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Large Intrauterine Polyps
Smaller Type 0 and 1 Myomas
Residual Placental Tissue
Procedure: Hysteroscopic morcellator
Procedure: Resectoscope
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: 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.

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Installation time and operating time. [ Time Frame: the length of the operation ] [ Designated as safety issue: No ]

    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.


  • Check for adhesions during follow-up. [ Time Frame: After 6 weeks, during follow-up visit ] [ Designated as safety issue: No ]
    Ambulant diagnostic hysteroscopy is performed at 6 weeks postoperative follow-up.


Secondary Outcome Measures:
  • Fluid deficit [ Time Frame: during the length of the operation ] [ Designated as safety issue: Yes ]
    Fluid deficit in both procedures is the result of subtracting the outflow volumes from the inflow volumes as measured by the pump.

  • complications and complaints [ Time Frame: between operation until 6 weeks follow-up ] [ Designated as safety issue: Yes ]

    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.



Estimated Enrollment: 222
Study Start Date: May 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01537822

Contacts
Contact: Tjalina Hamerlynck, MD Tjalina.Hamerlynck@ugent.be
Contact: Steven Weyers, MD, PhD Steven.Weyers@ugent.be

Locations
Belgium
Ghent University Hospital Recruiting
Ghent, Belgium, 9000
Contact: Steven Weyers, MD, PhD       Steven.Weyers@ugent.be   
Principal Investigator: Steven Weyers, MD, PhD         
Sub-Investigator: Tjalina Hamerlynck, MD         
Netherlands
Catharina Hospital Eindhoven Recruiting
Eindhoven, Netherlands, 5602 ZA
Contact: Benedictus C Schoot, MD, PhD         
Principal Investigator: Benedictus C Schoot, MD, PhD         
Sub-Investigator: Tjalina Hamerlynck, MD         
Sub-Investigator: Viviane Dietz, MD, PhD         
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Steven Weyers, MD, PhD Ghent University Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01537822     History of Changes
Other Study ID Numbers: 2011/679
Study First Received: February 15, 2012
Last Updated: January 29, 2013
Health Authority: Belgium: Ethics Committee

Keywords provided by University Hospital, Ghent:
intrauterine polyps
myomas
residual placental tissue

Additional relevant MeSH terms:
Polyps
Myoma
Uterine Neoplasms
Pathological Conditions, Anatomical
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on October 19, 2014