A New Alternative to Traditional Hysteroscopy
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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 |
- 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)
- 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 |
Inclusion Criteria:
- women between 18-75 years of age
- endometrial polyps and/or G0 myomas smaller than 3 cm of diameter
Contacts and Locations 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 May 16, 2013