Status:
COMPLETED
Surgical Correction of Pelvic Organ Prolapse
Lead Sponsor:
University Of Perugia
Conditions:
Pelvic Organ Prolapse
Eligibility:
FEMALE
18-75 years
Phase:
PHASE3
Brief Summary
Objective: This prospective randomized trial evaluated outcomes of colposacropexy performed either by open or by conventional laparoscopic approach as therapy for uterovaginal prolapse. Surgical tech...
Detailed Description
Surgical technique In both open or laparoscopic approach the anterior vaginal wall is dissected from the bladder to expose a vaginal wall area of at least 3 x 5 cms where the mesh will be attached wit...
Eligibility Criteria
Inclusion
- Study inclusion criteria were POP \> 2, age ≥ 18 and ≤ 75 yrs.
Exclusion
- Malignant uterus lesion (leiomyoma, fibromyoma, cervical or endometrial carcinoma)
- Active pelvic inflammatory disease,
- Known hypersensitivity to synthetic materials (polypropylene or polyglycolic acid)
- Pregnancy or lactation
- Evidence of clinically significant cardiovascular, renal, hepatic or respiratory diseases; and
- Any condition that in the judgment of the investigators would interfere with the subject's ability to provide informed consent, comply with study instructions, place the subject at increased risk, or which might confound interpretation of study results.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01182090
Start Date
August 1 2010
End Date
September 1 2012
Last Update
May 20 2014
Active Locations (1)
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1
Department of Medical-Surgical Specialties and Public Health, Section of Urology and Andrology
Perugia, Italy, 06100