Pragmatic Evaluation of Performance and Safety of the Anchorsure® Transvaginal Device for Surgical Treatment of Apical Prolapse in Women

Официальное название

APAS Study: Pragmatic Evaluation of the Performance and Safety of the Anchorsure System® Transvaginal Device for Surgical Treatment of Apical Prolapse in Women. A Post-market Multicentre Prospective Observational Cohort Study.

Обзор

Pelvic Organ Prolapse affects 50% of parous women, and apical prolapse is one of the most common types of prolapse. Treatment for apical prolapse ranges from observation, non-surgical treatment or surgical repair. An anchoring device can reduce dissection and operative time and is meant to provide strong fixation whilst minimizing potential postoperative pain by avoiding neurovascular injuries. These potential advantages must be evaluated in terms of performance and safety. This cohort study will be on patients undergoing sacrospinous fixation with the Anchorsure® system with a follow-up of 36 months.

Подробное описание

Pelvic Organ Prolapse affects 50% of parous women, and apical prolapse is one of the most frequent. Treatment options for women with apical prolapse range from observation, non-surgical treatment or surgical repair. The use of an anchoring device reduces dissection and operative time and is supposed to provide a strong fixation while minimizing potential postoperative pain by avoiding neurovascular injuries. These potential advantages have to be evaluated in terms of performance and safety. This is a cohort study on patients undergoing sacrospinous fixation with the Anchorsure® system with a follow-up of 36 months.The primary objective of the study is to evaluate the performance of the Anchorsure System® for sacrospinous suspension 12 months after surgical treatment of women with apical prolapse in real-life settings.

Вмешательства

• Устройство The Anchorsure System®
  Sacrospinous ligament fixation performed with the Anchorsure Device

Первичные конечные точки

• Successful performance after sacrospinous fixation of the Anchorsure System®. [Срок оценки: 12 months after fixation]

Вторичные конечные точки (12)

• Device or procedure-related adverse events: Daily Pain score [Срок оценки: Day 0 to Day 30]
• Device or procedure-related adverse events: Anchor palpability [Срок оценки: 36 months after surgery]
• Device or procedure-related adverse events: Abnormal findings on clinical examination [Срок оценки: 36 months after surgery]
• Type of sacrospinous fixation technique used [Срок оценки: Day 0]
• Success of the intervention [Срок оценки: 36 months after surgery]
• Complications/adverse events [Срок оценки: 36 months after surgery]
• Severity of adverse events [Срок оценки: 36 months after surgery]
• Compartments treated [Срок оценки: 36 months after surgery]
• Potential risk factors for the success/failure of the treatment at baseline: Age [Срок оценки: Day 0]
• Potential risk factors for the success/failure of the treatment at baseline: Body Mass Index [Срок оценки: Day 0]
• Potential risk factors for the success/failure of the treatment at baseline: Previous history of pelvic surgery [Срок оценки: Day 0]
• Potential risk factors for the success/failure of the treatment at baseline: Chronic constipation [Срок оценки: Day 0]

Критерии участия

Критерии включения

• Women with pelvic organ prolapse with leading edge at or beyond the hymen as confirmed by the pelvic organ prolapse quantification system (POP-Q), i.e. Ba ≥ -1 cm for the anterior compartment, and/or Bp ≥ -1 cm for the posterior compartment, and/or C ≥ -1 cm for the apical compartment including recurrence.
• Women due for POP surgery using the Anchorsure System® for apical prolapse suspension with or without concomitant native tissue repair, with or without concomitant hysterectomy and with or without concomitant sling for stress urinary incontinence.
• All women who have not indicated any objection to participating in the study.
• All women who have been correctly informed.

Критерии исключения

• Patient taking part or having taken part in a device or drug interventional study within the last three months (except for VIGI-MESH national registry).
• Patients due for pelvic organ prolapse repair without apical suspension or with anything other than native tissue repair and the Anchorsure System®.
• Patients with uncontrolled diabetes mellitus.
• Patients with active non-controlled or chronic gynaecologic or urinary tract infection and/or local tissue necrosis.
• Patients with ongoing pelvic organ cancer (e.g. uterine, ovarian, bladder, cervix …).
• Patients with a history of radiotherapy in the pelvic area.
• Patients on therapy with immunosuppressive or immunomodulatory treatment within the previous month.
• patients under ongoing oral anticoagulant therapy.
• Patients with stage 0 and 1 pelvic organ prolapse at the time of surgery
• Patients with a preoperative infection contraindicating the surgery

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

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 4 центра

• La Rochelle General Hospital — La Rochelle
• Lille University Hospital — Lille
• Kremlin-Bicêtre Hospital — Paris
• Clinique Sainte-Anne — Strasbourg

Идентификаторы

NCT: NCT05836844 · IDIL/2022/RdT01 2023-A00289-36

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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