Follow-up Study After Manchester Operation for Pelvic Organ Prolapse (MAP-POP)
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|ClinicalTrials.gov Identifier: NCT02246387|
Recruitment Status : Completed
First Posted : September 22, 2014
Last Update Posted : April 12, 2018
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).
|Condition or disease||Intervention/treatment|
|Pelvic Organ Prolapse||Procedure: Manchester Operation|
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. However the use of mesh has recently been put under scrutiny due to a high risk of complications, such as mesh exposure. The gran majority of the investigators patients are operated with native tissue repairs, about 60% of them by a Manchester procedure, where ligament plication is an essential part of the procedure. The investigators previous study documented high patient satisfaction and low risk of recurrence, but the data available were mainly collected retrospectively and no data were available on possible levator avulsions. Lateral defects caused by avulsions of the levator ani muscle represent a special sub-group amongst patients with POP, and are shown in several studies to have higher recurrence rates. There is no consensus on how to best repair a lateral defect in a POP, but since the prevalence of levator avulsions in patients with POP is shown to be high, the investigators find it credible that the Manchester Operation can give good results .
The main justification for this study is that the investigators already have identified a surgical technique that has documented excellent results, but studies with more detailed data quality are needed in order to better evaluate the procedure's advantages and potential disadvantages. As the use of mesh in vaginal surgery has shown unacceptable high risks of new and serious complications, there is an international focus and interest in traditional native tissue repairs and how to optimize their performance.
|Study Type :||Observational|
|Actual Enrollment :||209 participants|
|Official Title:||Does the Manchester Operation for Pelvic Organ Prolapse Give Sufficient Apical Fixation?|
|Actual Study Start Date :||October 2014|
|Actual Primary Completion Date :||January 2018|
|Actual Study Completion Date :||January 2018|
Manchester Operation: Native tissue repair
Procedure: Manchester Operation
A 3- compartment native tissue repair procedure for Pelvic Organ Prolapse.
- Percentage with POP-Q point C equal to or less than -5 at the 1 year postoperative control compared to preoperative findings for the whole population vs subgroup with levator avulsions. [ Time Frame: Up to 36 months ]
- Changes in point C and D at the 1 year postoperative control compared to preoperative findings for the whole population vs subgroup with levator avulsions. [ Time Frame: Up to 36 months ]
- Subjective satisfaction at the 1 year postoperative control (whole population vs subgroup with levator avulsions). [ Time Frame: Up to 36 months ]
- Changes in dyspareunia between the preoperative evaluation and at the 1 year postoperative control (whole population vs subgroup with levator avulsions). [ Time Frame: Up to 36 months ]
- De novo urinary incontinence at the 1 year postoperative control (whole population vs subgroup with levator avulsions). [ Time Frame: Up to 36 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02246387
|Gynekologisk avdeling, Oslo Universitetssykehus Ullevål|
|Oslo, Norway, 0424|
|Principal Investigator:||Sissel H Oversand, MD||Oslo University Hospital|
|Study Chair:||Anne C Staff, PhD||Oslo University Hospital; University of Oslo|
|Study Director:||Rune Svenningsen, PhD||Oslo University Hospital; University of Oslo|