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Идёт набор NCT07313839

Comparison of Self-Locking Versus Traditional Sutures in Double-Layer Laparoscopic Vaginal Vault Closure After Hysterectomy (BI-SURE Trial)

Без фазы С лечением Gynecologic Cancers Vaginal Cuff Dehiscence Postoperative Complications

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Double-Layer Vaginal Vault Closure with Self-Locking Suture, Double-Layer Vaginal Vault Closure with Polyglactin 910.
Кому может быть актуально
Состояния в реестре: Gynecologic Cancers, Vaginal Cuff Dehiscence, Postoperative Complications. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Италия
Следующий шаг
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Официальное название

Comparison Between Double-Layer Self-Locking and Traditional Sutures in Post-Hysterectomy Laparoscopic Colporrhaphy: A Multicenter Pragmatic Randomized Controlled Trial

Обзор

Vaginal vault closure after laparoscopic or robotic hysterectomy may be associated with postoperative complications such as vaginal cuff dehiscence, infection, and bleeding. The optimal suture material and technique for laparoscopic colporrhaphy, particularly in patients undergoing surgery for gynecologic malignancies, remain controversial. The BI-SURE trial is a multicenter, randomized controlled study designed to compare double-layer self-locking sutures versus double-layer traditional Polyglactin 910 sutures for laparoscopic vaginal vault closure after hysterectomy. The study aims to evaluate postoperative effectiveness and safety within three months after surgery.

Подробное описание

Laparoscopic and robotic hysterectomy represent standard surgical approaches for the treatment of gynecologic malignancies but are associated with a higher risk of vaginal vault complications compared with open or vaginal surgery. Although uncommon, postoperative complications such as vaginal cuff dehiscence, infection, and bleeding may lead to significant morbidity and require additional medical or surgical interventions.

Vaginal vault closure can be performed using different suturing techniques and materials. Traditional braided sutures, such as Polyglactin 910, are widely used in clinical practice, while self-locking (barbed) sutures have been introduced to facilitate laparoscopic suturing by maintaining tissue approximation without the need for knots. Evidence comparing these sutures is limited, particularly for double-layer closure techniques and in patients treated for gynecologic malignancies.

The BI-SURE trial is a multicenter, pragmatic, randomized controlled trial designed to compare double-layer self-locking sutures versus double-layer traditional Polyglactin 910 sutures for laparoscopic vaginal vault closure following hysterectomy for malignant gynecologic disease. Eligible patients will be randomized in a 1:1 ratio. Postoperative outcomes will be assessed up to three months after surgery, including vaginal cuff-related complications and postoperative pain.

Вмешательства

  • Процедура Double-Layer Vaginal Vault Closure with Self-Locking Suture
    Laparoscopic vaginal vault closure performed using a double-layer continuous suturing technique with a self-locking (barbed) suture following hysterectomy.
  • Процедура Double-Layer Vaginal Vault Closure with Polyglactin 910
    Laparoscopic vaginal vault closure performed using a double-layer continuous suturing technique with traditional braided Polyglactin 910 suture following hysterectomy.

Первичные конечные точки

  • Vaginal cuff dehiscence rate [Срок оценки: Within 3 months after surgery]
  • Vaginal cuff infection rate [Срок оценки: Within 3 months after surgery]
  • Postoperative bleeding rate [Срок оценки: Within 3 months after surgery]
Вторичные конечные точки (2)
  • Postoperative pain intensity [Срок оценки: At 1 month and 3 months after surgery]
  • Early postoperative composite complication rate [Срок оценки: Within 1 month after surgery]

Критерии участия

Критерии включения

  • Patients undergoing laparoscopic or robotically assisted hysterectomy for gynecologic malignant disease
  • Age ≥ 18 years
  • Ability to provide written informed consent

Критерии исключения

  • Laparotomic or vaginal hysterectomy
  • Contraindication to laparoscopic vaginal vault closure

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Тройное слепое
Основная цель
Лечение

Центры проведения

Италия · 5 центров
  • Department of Medicine and Surgery, University Hospital of Parma — Parma
  • Division of Oncologic Gynecology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, 4013 — Bologna
  • Department of Obstetrics and Gynecology, Ospedale Santa Croce e Carle, Cuneo, Italy. — Cuneo
  • Department of Gynecologic Oncology. Fondazione IRCCS Istituto Nazionale dei Tumori di Mila — Milan
  • Clinic of Obstetrics and Gynecology, "Santa Maria della Misericordia" University Hospital, — Udine

Идентификаторы

NCT: NCT07313839 · 415/2024/DISP/AOUPR

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗