The Benefits and Limits of Laparoscopic Surgery for Uterine Fibroids
N/A
20 Years
60 Years
20 Years
60 Years
Open (Enrolling)
Female
Uterine Fibroids
Female
Uterine Fibroids
Trial Information
The Benefits and Limits of Laparoscopic Surgery for Uterine Fibroids
Inclusion Criteria:
- symptomatic;
- having a wish to retain their uterus;
- an absence of previous abdominal or pelvic surgery;
- a number of visible uterine masses (myomas) less than or equal to 5 intramural or
sub-serous myomas (without peduncle);
- a maximum diameter of no more than 8 cm;
- an absence of prominent or significant pelvic adhesion on clinical evaluation; AND
- at least a 2-year thorough follow-up record available.
Exclusion Criteria:
- without pathological diagnosis of myoma if the specimen can be obtained; OR
- any violation the above-mentioned criteria.
Type of Study:
Observational
Study Design:
Observational Model: Case Control, Time Perspective: Prospective
Outcome Measure:
Surgical technique, patient suffering, and outcomes (symptom control, relapse of symptoms, re-intervention, regularity of menstrual cycles and pregnancy outcome) in both groups.
Outcome Time Frame:
2-years and 5 years
Safety Issue:
No
Authority:
Taiwan: Institutional Review Board
Study ID:
VGHIRB-98-01-20A
NCT ID:
NCT00860002
Start Date:
January 2009
Completion Date:
December 2014
Related Keywords:
- Uterine Fibroids
- myomectomy
- uterine artery occlusion
- uterine vessel occlusion
- fibroids
- leiomyomas
- Surgical technique, patient suffering and outcomes
- Leiomyoma
- Myofibroma
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