Native Tissue Repair in Pelvic Organ Prolapse -Long-term Results and Risk of Re-operation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

392 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-31

Study Completion Date

2024-12-31

Brief Summary

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This study evaluates the recurrence of pelvic organ prolapse and the rate of re-operation after primary surgery for anterior vaginal wall prolapse with native tissue repair in long term follow-up.

Detailed Description

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This was a retrospective cohort study including patients undergoing their first surgical intervention for pelvic organ prolapse in Turku University Hospital gynecology department in the years 2000-2005. The point of interest was to study patients with prolapse of the anterior vaginal compartment (i.e. cystocele) with native tissue repair surgical approach as treatment. We made a search from the medical database of surgical procedures for operation codes LEF00 (i.e.anterior colporraphy and LEF13 (i.e. vaginal hysterectomy of descended uterus with/without vaginal/perineal molding) during the studied period. Initially, we found 699 patients with matching operating codes and for those, we went through their medical records. From the final study population, we excluded those who had previously had an operation for pelvic organ prolapse and those whose primary operation didn't include anterior colporraphy and those who weren't eligible for long term follow-up. Thus, the study population constituted of 392 subjects who were followed through medical records until the end of October 2018.

From the medical records, we collected the day of birth, the date of the primary operation, body mass index, history of vaginal childbirth and cesarean section (if available), history of incontinence surgery, the grade of cystocele and diagnosis and before surgery, the operation code and executed surgical procedures, possible complications, and the history of possible re-operations. Also, the date of death was reported as well as the date of changing residence outside the Hospital District of Varsinais-Suomi.

All gathered information were saved without personal details.

Conditions

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Pelvic Organ Prolapse Cystocele

Keywords

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Recurrence Native tissue repair

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* cystocele treated with native tissue surgery, medical records reaching until the end of follow-up period

Exclusion Criteria

* history of previous pelvic organ prolapse surgery

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Pia Heinonen

MD, PhD, head of section, gynaecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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T43/2016

Identifier Type: -

Identifier Source: org_study_id