Status:
COMPLETED
Follow-up Study After Manchester Operation for Pelvic Organ Prolapse
Lead Sponsor:
Oslo University Hospital
Conditions:
Pelvic Organ Prolapse
Eligibility:
FEMALE
18+ years
Brief Summary
Native tissue repair for pelvic organ prolapse (POP) is the predominant surgical technique in the investigators department and the Manchester operation the preferred procedure. The investigators long-...
Detailed Description
Many studies have shown high recurrence rates after POP surgical repair using native tissue techniques, and this led to the introduction of synthetic meshes in vaginal repair in the early 2000s. Howev...
Eligibility Criteria
Inclusion
- Women aged ≥ 18 years, understanding and reading Scandinavian or English language and being able to sign an informed consent. Non- Scandinavian speakers can be enrolled in the study as long as they understand and can communicate in English or Norwegian.
- Subjective distress from pelvic organ prolapse
- Cystocele Stage I - III with descent of the cervix Stage I-III, with or without a defect of the posterior wall (rectocele, enterocele, hypotrophic perineum).
Exclusion
- Previous total hysterectomy (including removal of the cervix and the cardinal ligaments) or previous subtotal hysterectomy (removal of copus uteri).
- Previous surgery for POP
- Patients with a true Uterine prolapse with a descent of the corpus uteri stage II-III and not just an elongated cervix, as this group may benefit from other procedures than a Manchester operation (vaginal hysterectomy and sacrospinous fixation)
- Unable to understand patient information (in Norwegian or English) and sign an informed consent.
- Patients in whom a colpocleisis (closing of the vagina) is deemed the better surgical treatment, such as in elderly women not sexually active and not interested in future vaginal intercourse.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2023
Estimated Enrollment :
209 Patients enrolled
Trial Details
Trial ID
NCT02246387
Start Date
October 1 2014
End Date
January 1 2023
Last Update
November 2 2023
Active Locations (1)
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1
Gynekologisk avdeling, Oslo Universitetssykehus Ullevål
Oslo, Norway, 0424