Status:
ENROLLING_BY_INVITATION
Laparoscopic Pectopexy and Laparoscopic Colporrhaphies in Pelvic Organ Prolapse Treatment
Lead Sponsor:
Tampere University Hospital
Collaborating Sponsors:
Seinajoki Central Hospital
Conditions:
Vaginal Vault Prolapse
Uterine Prolapse
Eligibility:
FEMALE
18-79 years
Brief Summary
This prospective cohort study investigates the surgical outcomes of laparoscopic pectopexy and laparoscopic colporraphy performed at the Wellbeing Services County of South Ostrobothnia. The primary ou...
Detailed Description
The study aims to evaluate the effects of laparoscopic pectopexy and colporraphy on pelvic organ prolapse (POP) symptoms, anatomical prolapse repair, and surgical outcomes. The primary outcome measure...
Eligibility Criteria
Inclusion
- Symptomatic pelvic organ prolapse
- Uterine or vaginal vault prolapse reaching the hymenal ring (POP-Q classification: ≥0 cm)
- If uterus in situ, consent for supracervical hysterectomy
- Suitable for laparoscopic mesh surgery
- Age: 18-79 years
- Non-pregnant, no pregnancy desire.
- Sufficient Finnish language skills
- Concurrent anterior and/or posterior prolapse repair if POP-Q criteria met: tvl \>8 cm and Aa, Ba, Ap, Bp ≥0
Exclusion
- Unwillingness to undergo surgery or mesh implantation
- High anesthetic or surgical risk due to comorbidities
- Indication for laparoscopic sacrocolporectopexy due to rectal intussusception
- Desire to preserve the uterus
- Pregnancy or planning future pregnancy
- Inability to understand Finnish or study-related forms due to cognitive impairments
- Need for concomitant urinary incontinence surgery
Key Trial Info
Start Date :
February 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 28 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06902909
Start Date
February 1 2024
End Date
February 28 2027
Last Update
March 30 2025
Active Locations (1)
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1
The Wellbeing Services County of South Ostrobothnia
Seinäjoki, Finland, 60200