Endometrial Polypectomy Performed With Bipolar Electrode Versapoint vs Microscissors or Graspers

March 8, 2016 updated by: Stefano Angioni, University of Cagliari

Comparative Study of Endometrial Polypectomy Performed With Bipolar Electrode Versapoint vs Microscissors or Graspers

Hysteroscopy today is considered the gold standard for the diagnosis and treatment of endometrial polyps. Several hysteroscopic systems to resect endometrial polyps are currently available. Among Others bipolar systems and microscissors or graspers, both of theme make part of routine clinical practice and are universally accepted.

The aim of the study is to compare the efficacy of bipolar resection energy polypectomy versus microscissors or graspers These procedures assume a lower cost and are associated with a lower surgical risk due to their realization without anesthesia .

Hypothesis: Resection of polyps outpatient laser diode has a similar or superior to that of the bipolar electrode tolerability. The diode laser is a viable , quick , simple technique with a high percentage of resection and high degree of satisfaction of patients

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • The patient must be informed about the study, and sign the informed consent

Exclusion Criteria:

  • Positive Pap smear test
  • Pregnancy
  • Uterine malignancy
  • Abnormal uterine bleeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bipolar electrode
Polyps resection with bipolar electrode
Procedure: Bipolar Polypectomy
Polyps resection with bipolar electrode
Device: Bipolar electrode
Bipolar electrode used to performs polypectomy
Active Comparator: Microscissors or graspers
Polyps resection with microscissors or graspers
Procedure: Mechanical Polypectomy
Polyps resection with microscissors or graspers
Device: Microscissors or graspers
Mechanical instruments used to performs polypectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess the tolerability of polypectomy using a validated visual analogue pain scale
Time Frame: we measure pain after resection of endometrial polyps, with 5 minutes for the patient thinks
we measure pain after resection of endometrial polyps, with 5 minutes for the patient thinks

Other Outcome Measures

Outcome Measure
Time Frame
Assess the recurrence of polyps after 3 months of resection (another hysteroscopy).
Time Frame: 3 months after resection of the polyp, repeat hysteroscopy to assess recurrence
3 months after resection of the polyp, repeat hysteroscopy to assess recurrence

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cagliari

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

October 25, 2015

First Submitted That Met QC Criteria

October 27, 2015

First Posted (Estimate)

October 29, 2015

Study Record Updates

Last Update Posted (Estimate)

March 9, 2016

Last Update Submitted That Met QC Criteria

March 8, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • PolypectomyCA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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