A New Alternative to Traditional Hysteroscopy

September 7, 2011 updated by: Maurizio Guido, Catholic University of the Sacred Heart

New Mini-resectoscope as Alternative to Traditional Hysteroscopy in the Treatment of Uterine Lesions

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

401

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00168
        • Catholic University of Sacred Heart

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

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
Active Comparator: mini-resectoscope
Procedure: resectoscopy
hysteroscopy for myomas G0 and/or polyps
Active Comparator: tradiorional resectoscope
Procedure: resectoscopy
hysteroscopy for myomas G0 and/or polyps
Active Comparator: bettocchi resectoscope
Procedure: resectoscopy
hysteroscopy for myomas G0 and/or polyps

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
efficacy of the treatment with mini-resectoscope in comparison with the traditional hysteroscopy in the whole group of 401 patients
Time Frame: sixteen months
Operating time (min), distension media used (ml), dismiss time (hours), patients discomfort (VAS)
sixteen months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
efficacy of the treatment with mini-resectoscope in comparison with the traditional hysteroscopy in the treatment of intrauterine lesions larger than 1,5cm in diameter
Time Frame: sixteen months
Operating time(min), distension media used (ml), dismiss time (hours), patients discomfort (VAS)
sixteen months

Collaborators and Investigators

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

Sponsor

Catholic University of the Sacred Heart

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2010

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

September 2, 2011

First Submitted That Met QC Criteria

September 7, 2011

First Posted (Estimate)

September 8, 2011

Study Record Updates

Last Update Posted (Estimate)

September 8, 2011

Last Update Submitted That Met QC Criteria

September 7, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HUMREP-11-0778

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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