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Completed

NCT Number: NCT06744972

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Rate of re-operations

    Time frame: Long-term, at least 5 years follow up.

    Evaluate the risk of re-operation for pelvic organ prolapse and recurrence of surgically treated cystocele.

Sponsors and collaborators

Lead sponsor

Turku University Hospital

Other Gov

Registry information

Important dates

Study start
2015
Primary completion
2024
Study completion
2024
First posted
Dec 20, 2024
Registry last updated
Dec 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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