A New Alternative to Traditional Hysteroscopy

NCT ID: NCT01430208

Last Updated: 2011-09-08

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

COMPLETED

Clinical Phase

NA

Total Enrollment

401 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-06-30

Brief Summary

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Hysteroscopy is a procedure designed for the diagnosis and the treatment of intra-uterine diseases. The development of smaller hysteroscopes allowed to change the approach to the intra-uterine lesions unifying the diagnostic and operative time. Recently Gubbini et al. developed a mini-resectoscope feasible for "see\&treat" hysteroscopy. The objective of the study is to compare the new 16 Fr mini28 resectoscope by Gubbini with Traditional 22 Fr resectoscope and Bettocchi 15 Fr hysteroscope for the treatment of uterine cavitary lesions. The investigators enrolled 401 women affected by endometrial polyps and/or G0 myomas, randomly allocated to receive the treatment with traditional resectoscope (127 women), with mini-resectoscope by Gubbini (142 women) and Bettocchi hysteroscope (132 women). Operating time, distension media delivered, dismiss time and discomfort experienced were recorded.

Detailed Description

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Conditions

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Intrauterine Diseases Myomas 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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mini-resectoscope

Group Type ACTIVE_COMPARATOR

resectoscopy

Intervention Type PROCEDURE

hysteroscopy for myomas G0 and/or polyps

tradiorional resectoscope

Group Type ACTIVE_COMPARATOR

resectoscopy

Intervention Type PROCEDURE

hysteroscopy for myomas G0 and/or polyps

bettocchi resectoscope

Group Type ACTIVE_COMPARATOR

resectoscopy

Intervention Type PROCEDURE

hysteroscopy for myomas G0 and/or polyps

Interventions

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resectoscopy

hysteroscopy for myomas G0 and/or polyps

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* women between 18-75 years of age
* endometrial polyps and/or G0 myomas smaller than 3 cm of diameter
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Catholic University of the Sacred Heart

OTHER

Sponsor Role lead

Responsible Party

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Maurizio Guido

medical doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Catholic university of Sacred Heart

Rome, Rome, Italy

Site Status

Countries

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Italy

References

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Ricciardi R, Lanzone A, Tagliaferri V, Di Florio C, Ricciardi L, Selvaggi L, Guido M. Using a 16-French resectoscope as an alternative device in the treatment of uterine lesions: a randomized controlled trial. Obstet Gynecol. 2012 Jul;120(1):160-5. doi: 10.1097/AOG.0b013e31825b9086.

Reference Type DERIVED
PMID: 22914405 (View on PubMed)

Other Identifiers

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HUMREP-11-0778

Identifier Type: -

Identifier Source: org_study_id

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