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

NCT01509313 | Completed Phase 3

• 1 other identifier: PPS-MERT-01
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Endometrial Polyps

Keywords

endometrial polyps; uterine polyps; morcellator; hysteroscopy

Outcome Measures

Primary Outcomes (1)

• The time taken for polyp removal

  The time taken to remove the polyp will be defined as the time from insertion to removal of vaginal instrumentation post-randomisation

  at the time of surgery (day 1 intraoperatively)

Secondary Outcomes (2)

• Patient acceptability or pain

  immediately after the surgery (day 1)

• Completion of polyp removal

  at the time of surgery (day 1 intraoperatively)

Study Arms (2)

Uterine polypectomy using morcellator

EXPERIMENTAL

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)

Electical Resection

ACTIVE COMPARATOR

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)

Interventions

hysteroscopic morcellator (TruClear) DEVICE

It can be used to treat uterine pathology with a mechanical cutting edge

Also known as: TruClear(Smith&Nephew, USA)

Uterine polypectomy using morcellator

Bipolar Electrical resectoscope (Versapoint) DEVICE

It can be used to treat uterine pathology with an electrical cutting edge

Also known as: Versapoint® (Gynecare; Ethicon Inc., New Jersey, USA).

Electical Resection

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Finding of a benign polyp on diagnostic hysteroscopy

You may not qualify if:

• Need for polypectomy
• Written informed consent
• Hysteroscopic features suggesting malignant lesion

Sponsors & Collaborators

• Birmingham Women's NHS Foundation Trust: lead
• Smith & Nephew, Inc.: collaborator

Study Sites (1)

Birmingham Womens Hospital

Birmingham, West Midlands, B15 2TG, United Kingdom

Location

Related Publications (1)

• Smith PP, Middleton LJ, Connor M, Clark TJ. Hysteroscopic morcellation compared with electrical resection of endometrial polyps: a randomized controlled trial. Obstet Gynecol. 2014 Apr;123(4):745-51. doi: 10.1097/AOG.0000000000000187.

  PMID: 24785600 DERIVED

Study Officials

• Thomas J Clark, MBChB

  Birmingham Womens Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Obstetrics and Gynaecologist

Study Record Dates

• First Submitted: January 5, 2012
• First Posted: January 13, 2012
• Study Start: June 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: September 16, 2013

Record last verified: 2013-09

Locations

GB (1)