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Follow-up Study After Manchester Operation for Pelvic Organ Prolapse

NCT02246387 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 209

Last updated 2023-11-02

No results posted yet for this study

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-term reoperation rates for pevic organ prolapse are very low, as documented in the investigators previous long-term follow-up study (Oversand et al, International Urogynecology Journal 2013), however the data were retrospective and patients with avulsions of the levator ani muscle were not identified. The investigators hypothesize that correct fixation and elevation of the vaginal apex, as part of a three-compartment repair procedure, is essential in the POP surgical repair, also when treating women with levator ani avulsions.

The purpose of this study is to:

* prospectively evaluate if cardinal/sacrouterine ligament plication (as part of the 3-compartment Manchester procedure) gives an adequate elevation and fixation of the vaginal apex.
* assess changes in subjective symptoms between the preoperative evaluation and the 1 and 5-year postoperative evaluations.
* evaluate whether the patients identified with levator avulsions in the investigators population have an increased risk of failure (objectively and subjectively).

Conditions

  • Pelvic Organ Prolapse

Interventions

PROCEDURE

Manchester Operation

A 3- compartment native tissue repair procedure for Pelvic Organ Prolapse.

Sponsors & Collaborators

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Sissel H Oversand, MD · Oslo University Hospital

  • Anne C Staff, PhD · Oslo University Hospital; University of Oslo

  • Rune Svenningsen, PhD · Oslo University Hospital; University of Oslo

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2018-01-31
Completion
2023-01-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02246387 on ClinicalTrials.gov