Transvaginal Sacrospinous Hysteropexy Versus Laparoscopic Uterine Lateral Suspension
A Prospective, Observational Trial of Transvaginal Uterine Suspension With the New Minimally Invasive Uterine Suspension
National Cheng-Kung University Hospital
90 participants
Jul 26, 2022
OBSERVATIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria8
- 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.
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Interventions
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 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.
Locations(1)
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NCT05586984