New Mini-resectoscope as Alternative to Traditional Hysteroscopy in the Treatment of Uterine Lesions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 401
- Locations
- 1
- Primary Endpoint
- efficacy of the treatment with mini-resectoscope in comparison with the traditional hysteroscopy in the whole group of 401 patients
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- 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
Exclusion Criteria
- Not provided
Arms & Interventions
mini-resectoscope
Intervention: resectoscopy (Procedure)
tradiorional resectoscope
Intervention: resectoscopy (Procedure)
bettocchi resectoscope
Intervention: resectoscopy (Procedure)
Outcomes
Primary Outcomes
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 Outcomes
- 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)
Investigators
Maurizio Guido
medical doctor
Catholic University of the Sacred Heart