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A New Alternative to Traditional Hysteroscopy

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ClinicalTrials.gov Identifier: NCT01430208
Recruitment Status : Completed
First Posted : September 8, 2011
Last Update Posted : September 8, 2011
Sponsor:
Information provided by (Responsible Party):
Maurizio Guido, Catholic University of the Sacred Heart

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Intrauterine Diseases Myomas Polyps Procedure: resectoscopy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 401 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: New Mini-resectoscope as Alternative to Traditional Hysteroscopy in the Treatment of Uterine Lesions
Study Start Date : January 2010
Actual Primary Completion Date : April 2011
Actual Study Completion Date : June 2011

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



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01430208


Locations
Italy
Catholic university of Sacred Heart
Rome, Italy, 00168
Sponsors and Collaborators
Catholic University of the Sacred Heart

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Maurizio Guido, medical doctor, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT01430208     History of Changes
Other Study ID Numbers: HUMREP-11-0778
First Posted: September 8, 2011    Key Record Dates
Last Update Posted: September 8, 2011
Last Verified: September 2011

Keywords provided by Maurizio Guido, Catholic University of the Sacred Heart:
endometrial pathology