Laparoscopic Pectopexy and Laparoscopic Colporrhaphies in Pelvic Organ Prolapse Treatment (NCT06902909) | Clinical Trial Compass
By InvitationNot Applicable
Laparoscopic Pectopexy and Laparoscopic Colporrhaphies in Pelvic Organ Prolapse Treatment
Finland50 participantsStarted 2024-02-01
Plain-language summary
This prospective cohort study investigates the surgical outcomes of laparoscopic pectopexy and laparoscopic colporraphy performed at the Wellbeing Services County of South Ostrobothnia. The primary outcome measure is to assess changes in sensation of bulge and pressure. Secondary outcome measures include evaluating other prolapse symptoms and pain, quality of life, anatomical correction of prolapse, surgical safety parameters, and postoperative complications. Approximately 40-50 laparoscopic pectopexies will be performed over two years by a single experienced surgeon. The study requires preoperative and postoperative assessments, including standardized patient questionnaires and anatomical measurements.
Who can participate
Age range
18 Years – 79 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Symptomatic pelvic organ prolapse
* Uterine or vaginal vault prolapse reaching the hymenal ring (POP-Q classification: ≥0 cm)
* If uterus in situ, consent for supracervical hysterectomy
* Suitable for laparoscopic mesh surgery
* Age: 18-79 years
* Non-pregnant, no pregnancy desire.
* Sufficient Finnish language skills
* Concurrent anterior and/or posterior prolapse repair if POP-Q criteria met: tvl \>8 cm and Aa, Ba, Ap, Bp ≥0
Exclusion Criteria:
* Unwillingness to undergo surgery or mesh implantation
* High anesthetic or surgical risk due to comorbidities
* Indication for laparoscopic sacrocolporectopexy due to rectal intussusception
* Desire to preserve the uterus
* Pregnancy or planning future pregnancy
* Inability to understand Finnish or study-related forms due to cognitive impairments
* Need for concomitant urinary incontinence surgery
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Patient-reported postoperative sensation of bulging at 12 months postoperatively
Timeframe: From the enrollment til follow-up visit at 12 months postoperatively