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Идёт набор NCT06024109

Performance of SYMMCORA® vs. V-Loc® Suture Material in Patients Undergoing Laparoscopic Total Hysterectomy

— Наблюдательное Abnormal Uterine Bleeding Endometriosis Uterine Prolapse Uterine Cancer

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: Closure of the Vaginal Cuff after Total Hysterectomy.
Кому может быть актуально
Состояния в реестре: Abnormal Uterine Bleeding, Endometriosis, Uterine Prolapse, Uterine Cancer. 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
Германия, Испания
Следующий шаг
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Официальное название

Prospective, International, Randomized, Multicentric, Controlled Study on the Performance of SYMMCORA® Mid-term Unidirectional Barbed Suture Versus V-loc® Suture Material in Patients Undergoing Laparoscopic Total Hysterectomy

Обзор

The aim of this study is to show the superiority of the new unidirectional barbed suture (SYMMCORA® mid-term, unidirectional) to conventional suture material in terms of time to perform the vaginal cuff closure during gynecologic surgeries without an increase in the complication rate. Secondly, the superiority of SYMMCORA®, mid-term unidirectional compared to the V-Loc®, unidirectional will be assessed regarding the mean time to close the vaginal cuff. The study will be performed in routine clinical setting, the only difference will be the randomization into two different suture groups. Both suture materials which will be applied to approximate the vaginal cuff are approved and carrying the CE-marks. Additionally, both sutures will be applied in their intended use. Neither additional invasive measures nor additional burden in regard to the patient will be performed.

Вмешательства

  • Устройство Closure of the Vaginal Cuff after Total Hysterectomy
    Closure of the vaginal cuff in patients undergoing laparoscopic total hysterectomy. The product under investigation and the comparator suture material will be used in routine clinical practice and according to the Instructions for Use (IfU).

Первичные конечные точки

  • Suturing time to close the vaginal cuff [Срок оценки: intraoperatively]
Вторичные конечные точки (12)
  • Number of patients with early complications [Срок оценки: at discharge (up to 10 days after surgery)]
  • Number of patients with complications over the study period [Срок оценки: at discharge (up to 10 days after surgery), 6-8 weeks postoperatively, 6 months postoperatively]
  • Number of patients with device deficiencies over the study period [Срок оценки: intraoperatively, at discharge (up to 10 days after surgery), 6-8 weeks postoperatively, 6 months postoperatively]
  • Patient satisfaction (VAS 0-100) over time [Срок оценки: at discharge (up to 10 days after surgery), 6-8 weeks postoperatively, 6 months postoperatively]
  • Progress of Female Sexual Function Index (FSFI) compared to baseline [Срок оценки: Preoperatively (baseline), at follow-up visits 6-8 weeks postoperatively and 6 months postoperatively]
  • Overall operation time [Срок оценки: intraoperatively]
  • Cost of treatment [Срок оценки: at discharge (approximately 10 days after surgery)]
  • Length of postoperative hospital stay [Срок оценки: at discharge (approximately 10 days after surgery)]
  • Progress of Patient's abdominal pain (VAS 0-100) compared to baseline [Срок оценки: preoperatively (baseline) and at discharge (up to 10 days after surgery), 6-8 weeks postoperatively, 6 months postoperatively]
  • Progress of Patient's pelvic pain (VAS 0-100) compared to baseline [Срок оценки: preoperatively (baseline) and at discharge (up to 10 days after surgery), 6-8 weeks postoperatively, 6 months postoperatively]
  • Progress of Patient's lumbar pain (VAS 0-100) compared to baseline [Срок оценки: preoperatively (baseline) and at discharge (up to 10 days after surgery), 6-8 weeks postoperatively, 6 months postoperatively]
  • Progress of General Health Status compared to baseline [Срок оценки: preoperatively (baseline) and at discharge (up to 10 days after surgery), 6-8 weeks postoperatively, 6 months postoperatively]

Критерии участия

Критерии включения

  • Females undergoing an elective, laparoscopic total hysterectomy
  • Age ≥ 18 years
  • Written informed consent

Критерии исключения

  • Emergency surgery
  • Open surgery
  • Patients undergone immunosuppressive drug treatment within the prior 6 months
  • Patients with hypersensitivity or allergy to the suture material.
  • Participation in another clinical study
  • Non-compliance of patient

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Германия · 1 центр
  • Klinikum Sachsenhausen der DGD — Frankfurt am Main
Испания · 1 центр
  • Hospital Sant Joan de Déu de Manresa — Manresa

Публикации

  • Baumann P, Sanchez LH, Garcia NG, Sologiuc L, Hornemann A. Assessment of a novel unidirectional mid-term absorbable barbed suture versus a competitor barbed suture for vaginal cuff closure after gynaecology surgery, study protocol of a randomized controlled trial - BARHYSTER. BMC Surg. 2025 Jan 14;25(1):23. doi: 10.1186/s12893-024-02700-z. PMID 39806425

Идентификаторы

NCT: NCT06024109 · AAG-O-H-2001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗