A Trial Comparing Morcellation With Electrical Resection for Removal of Uterine Polyps (MERT)

This study has been completed.
Sponsor:
Collaborator:
Smith & Nephew, Inc.
Information provided by (Responsible Party):
Thomas Justin Clark, Birmingham Women's NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01509313
First received: January 5, 2012
Last updated: September 13, 2013
Last verified: September 2013
  Purpose

Outpatient polyp treatment can be performed in a few different ways but generally involves passing a special type of hysteroscope (3-6 millimetre in diameter) into the womb through which specifically designed miniature operating instruments are passed to remove the polyp(s). At present the most commonly used instruments use an electrical cutting edge. However, a new instrument using a mechanical cutting edge has come to market. In patients having a general anaesthesia the mechanical cutting instrument has been shown to be easier to learn, more effective at completely removing polyps and quicker. However, the instrument is slightly larger, which could potentially cause more discomfort and prolong the procedure in the outpatient setting. Therefore, the investigators want to compare the electrical and mechanical instruments for speed, completeness of polyp removal and patient acceptability.


Condition Intervention Phase
Endometrial Polyps
Device: hysteroscopic morcellator (TruClear)
Device: Bipolar Electrical resectoscope (Versapoint)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial Comparing Morcellation With Electrical Resection for Removal of Uterine Polyps

Further study details as provided by Birmingham Women's NHS Foundation Trust:

Primary Outcome Measures:
  • The time taken for polyp removal [ Time Frame: at the time of surgery (day 1 intraoperatively) ] [ Designated as safety issue: No ]
    The time taken to remove the polyp will be defined as the time from insertion to removal of vaginal instrumentation post-randomisation


Secondary Outcome Measures:
  • Patient acceptability or pain [ Time Frame: immediately after the surgery (day 1) ] [ Designated as safety issue: No ]
    The acceptability of the trial will be assessed a questionnaire using pain visual analogue scores. The patient will be given a preoperative questionnarie to get a pain baseline and this will be followed postoperative pain questionnaire.

  • Completion of polyp removal [ Time Frame: at the time of surgery (day 1 intraoperatively) ] [ Designated as safety issue: No ]
    A complete uterine polypectomy will be defined as the detachment and retrieval of all visible polyp tissue (single or multiple polyps), such that no polyp remnants remain within the uterine cavity. An incomplete procedure will include any of the following: (i) failure to detach any polyp tissue from the uterine wall; (ii) partial detachment of polyp(s) from the uterine wall and (iii) failure to retrieve the detached specimen from the uterine cavity


Enrollment: 121
Study Start Date: June 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Uterine polypectomy using morcellator
A new instrument using a mechanical cutting edge has come to market for uterine polypectomy. In patients having a general anaesthesia the mechanical cutting instrument has been shown to be easier to learn, more effective at completely removing polyps and quicker than current techniques. However, the instrument is slightly larger, which could potentially cause more discomfort and prolong the procedure in the outpatient setting.
Device: hysteroscopic morcellator (TruClear)
It can be used to treat uterine pathology with a mechanical cutting edge
Other Name: TruClear(Smith&Nephew, USA)
Active Comparator: Electical Resection
At present the most commonly used device for removing the uterine polyps in the outpatient setting is by electrical resection. This will provide comparison for the morcellator device being tested
Device: Bipolar Electrical resectoscope (Versapoint)
It can be used to treat uterine pathology with an electrical cutting edge
Other Name: Versapoint® (Gynecare; Ethicon Inc., New Jersey, USA).

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Finding of a benign polyp on diagnostic hysteroscopy
  • Patient considered able to tolerate outpatient hysteroscopic polypectomy based upon the response to preliminary diagnostic hysteroscopy. NB. all polyps diagnosed at hysteroscopy will be considered feasible to remove in the outpatient setting regardless of size, location or number. Patient factor(s) will be the only exclusion criteria following the diagnosis of benign, uterine polyp(s).
  • Need for polypectomy
  • Written informed consent

Exclusion Criteria:

• Hysteroscopic features suggesting malignant lesion

  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: NCT01509313

Locations
United Kingdom
Birmingham Womens Hospital
Birmingham, West Midlands, United Kingdom, B15 2TG
Sponsors and Collaborators
Birmingham Women's NHS Foundation Trust
Smith & Nephew, Inc.
Investigators
Principal Investigator: Thomas J Clark, MBChB Birmingham Womens Hospital
  More Information

No publications provided by Birmingham Women's NHS Foundation Trust

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Thomas Justin Clark, Consultant Obstetrics and Gynaecologist, Birmingham Women's NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01509313     History of Changes
Other Study ID Numbers: PPS-MERT-01
Study First Received: January 5, 2012
Last Updated: September 13, 2013
Health Authority: United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

Keywords provided by Birmingham Women's NHS Foundation Trust:
endometrial polyps
uterine polyps
morcellator
hysteroscopy

Additional relevant MeSH terms:
Polyps
Uterine Neoplasms
Pathological Conditions, Anatomical
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 18, 2014