A New Alternative to Traditional Hysteroscopy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Maurizio Guido, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT01430208
First received: September 2, 2011
Last updated: September 7, 2011
Last verified: September 2011
  Purpose

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 Intervention
Intrauterine Diseases
Myomas
Polyps
Procedure: resectoscopy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: New Mini-resectoscope as Alternative to Traditional Hysteroscopy in the Treatment of Uterine Lesions

Further study details as provided by Catholic University of the Sacred Heart:

Primary Outcome Measures:
  • efficacy of the treatment with mini-resectoscope in comparison with the traditional hysteroscopy in the whole group of 401 patients [ Time Frame: sixteen months ] [ Designated as safety issue: No ]
    Operating time (min), distension media used (ml), dismiss time (hours), patients discomfort (VAS)


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Operating time(min), distension media used (ml), dismiss time (hours), patients discomfort (VAS)


Enrollment: 401
Study Start Date: January 2010
Study Completion Date: June 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01430208

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

No publications provided by Catholic University of the Sacred Heart

Additional 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
Study First Received: September 2, 2011
Last Updated: September 7, 2011
Health Authority: Italy: Catholic University of Sacred Heart

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

Additional relevant MeSH terms:
Myoma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on July 26, 2014