NCT05586984 Transvaginal Sacrospinous Hysteropexy Versus Laparoscopic Uterine Lateral Suspension
| NCT ID | NCT05586984 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Cheng-Kung University Hospital |
| Condition | Pelvic Organ Prolapse |
| Study Type | OBSERVATIONAL |
| Enrollment | 90 participants |
| Start Date | 2022-07-26 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 90 participants in total. It began in 2022-07-26 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Transvaginal or transabdominal surgeries are current choices of uterus-preserving surgeries for pelvic organ prolapse. Laparoscopic lateral uterine suspension, a modified surgical approach of uterine suspension from bilateral abdominal wall fascia, performed with expected safety and simplicity of surgery besides advantages including small wound incision and fast recovery in laparoscopic surgeries. This trial aim to discuss the therapeutic efficacy, long term safety, and adverse events of laparoscopic lateral uterine suspension and compare with the conventional transvaginal sacrospinous ligament fixation with native tissue repair.
Eligibility Criteria
Inclusion Criteria: * older than 21 years old. * uterine prolapse stage 2 at least, defined by C point distal to -1cm by POP-Q system. * patients willing to receive a uterine-preserving surgery for pelvic organ prolapse, and is suitable for anesthesia after evaluation. * patients who had or had not received conservative treatments for pelvic organ prolapse. * patients able and willing to finish the questionnaire evaluation. Exclusion Criteria: * patient who had received a previous hysterectomy, or is planning on concomitant hysterectomy in the surgery for pelvic organ prolapse. * patient who had received a previous surgery for pelvic organ prolapse. * patient with history of adverse events following a synthetic mesh. * patients with chronic or acute pelvic pain. * patients who had received abdominal or pelvic irradiation. * patients who cannot receive either surgery due to comorbidity. * patients pregnant or with future plan of pregnancy. * patients with vaginal length less than 5cm.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05586984 clinical trial?
This trial is open to female participants only, aged 21 Years or older, studying Pelvic Organ Prolapse. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05586984 currently recruiting?
Yes, NCT05586984 is actively recruiting participants. Contact the research team at yufangh@ncku.edu.tw for enrollment information.
Where is the NCT05586984 trial being conducted?
This trial is being conducted at Tainan, Taiwan.
Who is sponsoring the NCT05586984 clinical trial?
NCT05586984 is sponsored by National Cheng-Kung University Hospital. The trial plans to enroll 90 participants.