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Clinical Trials in Taiwan / NCT05586984
Recruiting Observational

Transvaginal Sacrospinous Hysteropexy Versus Laparoscopic Uterine Lateral Suspension

NCT05586984 · tracked via the Priya Life Science Taiwan tracker
Sponsor
National Cheng-Kung University Hospital
Phase
Observational
Started
2022-07-26
Last updated
2022-10-21

Condition(s) studied

Pelvic Organ ProlapseUterine Prolapse

Investigational drug(s) / intervention(s)

Laparoscopic uterine lateral suspensionTransvaginal sacrospinous fixation

Laparoscopic uterine lateral suspension: Laparoscopic uterine lateral suspension done with four trocar sites. Fix a 1.5cm\*32cm mesh to uterus at anterior lower segment and bilateral round ligaments by non-absorbable sutures (Surgilon 2-0, Ethicon, Norderstedt, Germany), and to lateral abdominal fascia by non-absorbable sutures (Prolene 1-0, Ethicon, Norderstedt, Germany). Reperitonization done to avoid mesh exposure in peritoneal cavity. Concomitant anterior and posterior colporrhaphy may be performed.

Transvaginal sacrospinous fixation: Transvaginal sacrospinous fixation done by hand suturing uterus to right sacrospinous ligament with non-absorbable suture (Prolene 1-0, Ethicon, Norderstedt, Germany). Concomitant anterior and posterior colporrhaphy may be performed.

Study 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

Sex
FEMALE
Min age
21 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Recurrence — 5 years
    Composite outcome of subjective and objective recurrence of uterine prolapse.

Trial sites (1)

FacilityCityRegionStatus
National Cheng Kung University Hospital Tainan Taiwan Recruiting

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Other trials for the same condition

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05586984 on ClinicalTrials.gov ↗ ← All trials in Taiwan