Status:
UNKNOWN
Continuous Locked Non-barbed Suture for Mesh Fixation During Laparoscopic Sacral Colpopexy for Severe Pelvic Organ Prolapse
Lead Sponsor:
Azienda Ospedaliera Cardinale G. Panico
Conditions:
Pelvic Organ Prolapse
Eligibility:
FEMALE
50-80 years
Phase:
NA
Brief Summary
This prospective randomized pilot study is aimed to verify if the operative time of a standard laparoscopic sacral colpopexy associated to subtotal hysterectomy for the treatment of POP could be furth...
Detailed Description
Introduction Pelvic-organ prolapse, in which the pelvic organs (uterus, bladder, and bowel) protrude into or past the vaginal introitus, is a condition often treated with surgery. Women have an 11 per...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- For patients
- Age ≤ 80 years
- Patient's informed consent
- American Society of Anesthesiologists: \< class III or IV
- Physiologic, surgical or iatrogenic menopause.
- No previous major abdominal surgical procedures
- For diseases
- POP-Q stage III/IV for anterior and/or apical compartment; stage \<III for posterior compartment.
- No uterine cervix dysplasia or endometrial disorders.
- No uterine size larger than conform 10 weeks gestation
Exclusion
Key Trial Info
Start Date :
January 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2018
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03427606
Start Date
January 1 2016
End Date
April 1 2018
Last Update
March 26 2018
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