Endometrial Polypectomy Performed With Bipolar Electrode Versapoint vs Microscissors or Graspers

NCT ID: NCT02590666

Last Updated: 2016-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-09-30

Brief Summary

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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

Detailed Description

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Conditions

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Endometrial Polyps

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bipolar electrode

Polyps resection with bipolar electrode

Group Type EXPERIMENTAL

Bipolar Polypectomy

Intervention Type PROCEDURE

Polyps resection with bipolar electrode

Bipolar electrode

Intervention Type DEVICE

Bipolar electrode used to performs polypectomy

Microscissors or graspers

Polyps resection with microscissors or graspers

Group Type ACTIVE_COMPARATOR

Mechanical Polypectomy

Intervention Type PROCEDURE

Polyps resection with microscissors or graspers

Microscissors or graspers

Intervention Type DEVICE

Mechanical instruments used to performs polypectomy

Interventions

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Bipolar Polypectomy

Polyps resection with bipolar electrode

Intervention Type PROCEDURE

Mechanical Polypectomy

Polyps resection with microscissors or graspers

Intervention Type PROCEDURE

Bipolar electrode

Bipolar electrode used to performs polypectomy

Intervention Type DEVICE

Microscissors or graspers

Mechanical instruments used to performs polypectomy

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Cagliari

OTHER

Sponsor Role lead

Responsible Party

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Stefano Angioni

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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PolypectomyCA

Identifier Type: -

Identifier Source: org_study_id

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