A New Alternative to Traditional Hysteroscopy
New Mini-resectoscope as Alternative to Traditional Hysteroscopy in the Treatment of Uterine Lesions
1 other identifier
interventional
401
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 2, 2011
CompletedFirst Posted
Study publicly available on registry
September 8, 2011
CompletedSeptember 8, 2011
September 1, 2011
1.2 years
September 2, 2011
September 7, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
efficacy of the treatment with mini-resectoscope in comparison with the traditional hysteroscopy in the whole group of 401 patients
Operating time (min), distension media used (ml), dismiss time (hours), patients discomfort (VAS)
sixteen months
Secondary Outcomes (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
sixteen months
Study Arms (3)
mini-resectoscope
ACTIVE COMPARATORtradiorional resectoscope
ACTIVE COMPARATORbettocchi resectoscope
ACTIVE COMPARATORInterventions
hysteroscopy for myomas G0 and/or polyps
Eligibility Criteria
You may qualify if:
- women between 18-75 years of age
- endometrial polyps and/or G0 myomas smaller than 3 cm of diameter
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Catholic university of Sacred Heart
Rome, Rome, 00168, Italy
Related Publications (1)
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.
PMID: 22914405DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- medical doctor
Study Record Dates
First Submitted
September 2, 2011
First Posted
September 8, 2011
Study Start
January 1, 2010
Primary Completion
April 1, 2011
Study Completion
June 1, 2011
Last Updated
September 8, 2011
Record last verified: 2011-09