Transvaginal Sacrospinous Hysteropexy Versus Laparoscopic Uterine Lateral Suspension

Официальное название

A Prospective, Observational Trial of Transvaginal Uterine Suspension With the New Minimally Invasive Uterine Suspension

Обзор

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.

Подробное описание

Pelvic organ prolapse can be treated either conservatively or surgically. Patients who are unsatisfied with conservative treatment or with severe symptoms often seek for surgical intervention. Transvaginal or transabdominal surgeries are current choices of uterus-preserving surgeries for pelvic organ prolapse. Laparoscopic sacrohysteropexy is the current trend for laparoscopic surgery, with small incisional wound, fast recovery, and low recurrence rate as advantages. However, laparoscopic sacrohysteropexy is often regarded as time consuming and ous sometimes hazard given the complexity of surgical technique and the anatomy of the presacral region. Few cases with severe complications such as vascular injuries, sacral nerve root injuries, and diskitis had been reported with laparoscopic sacrohysteropexy in previous studies.

Laparoscopic lateral uterine suspension, a modified surgical approach of uterine suspension from bilateral abdominal wall fascia, is therefore proposed in our study. The most significant benefits of this novel approach include 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 of laparoscopic lateral uterine suspension and compare with the transvaginal sacrospinous ligament fixation with native tissue repair. Other results include safety and adverse events of laparoscopic lateral uterine suspension in long term follow up.

Вмешательства

• Процедура 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.
• Процедура 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.

Первичные конечные точки

• Recurrence [Срок оценки: 5 years]

Вторичные конечные точки (4)

• Anatomical outcome [Срок оценки: 5 years]
• Functional outcome [Срок оценки: 5 years]
• Sexual function outcome [Срок оценки: 5 years]
• Urodynamic outcome [Срок оценки: 6 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Тайвань · 1 центр

• National Cheng Kung University Hospital — Tainan

Идентификаторы

NCT: NCT05586984 · 111-NCKUH-CTC--IIT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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