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Идёт набор NCT06658145

Safety and Efficacy of Using a Novel Full Visual Access Platform System in Transvaginal Hysterectomy

Без фазы С лечением Uterine Myoma Surgery, Laparoscopic

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: Vnotes surgery using fully visualised surgical instruments, Vnotes surgery using traditional surgical instruments.
Кому может быть актуально
Состояния в реестре: Uterine Myoma, Surgery, Laparoscopic. Базовые параметры: до 60 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
Китай
Следующий шаг
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Официальное название

The Establishment and Clinical Study of the Whole Visual VNOTES Approach Platform

Обзор

The modified vNOTES hysterectomy was accomplished and validated for efficacy and safety using a multi-access vaginal confinement instrument with a fully visualised vaginal access platform.

Подробное описание

A multi-center prospective randomized controlled trial was conducted to evaluate the efficacy and safety of the vNOTES technique in patients with uterine fibroids who were scheduled for total hysterectomy. The patients were randomly assigned to the vNOTES group (experimental group) and the traditional vNOTES group (control group). The access platform was established using a visualization method or the traditional laparoscopic method, and the surgical operation was completed. The time required to establish the platform, the amount of bleeding, the total surgical time, the anesthesia indicators, complications, and follow-up indicators were recorded, and the effectiveness and safety of the technique were evaluated.

Вмешательства

  • Устройство Vnotes surgery using fully visualised surgical instruments
    Vnotes surgery using fully visualised surgical instruments
  • Устройство Vnotes surgery using traditional surgical instruments
    Vnotes surgery using traditional surgical instruments

Первичные конечные точки

  • Success rate of access platform establishment [Срок оценки: End of surgery]
Вторичные конечные точки (12)
  • Tightness of equipment [Срок оценки: End of surgery]
  • Stability of equipment [Срок оценки: End of surgery]
  • Controllability of equipment [Срок оценки: End of surgery]
  • Time of establishment of the access platform [Срок оценки: End of surgery]
  • Total time of surgery [Срок оценки: End of surgery]
  • Total surgical bleeding volume [Срок оценки: End of surgery]
  • The amount of bleeding during the process of establishing the platform [Срок оценки: End of surgery]
  • Surgical complications [Срок оценки: 6 months after surgery]
  • Length of hospital stay [Срок оценки: 6 months after surgery]
  • Pain VAS score [Срок оценки: 6 months after surgery]
  • The Patients' life quality postoperative [Срок оценки: 6 months after surgery]
  • Heart rate during surgery [Срок оценки: End of surgery]

Критерии участия

Критерии включения

  • Female patients ≤ 60years old
  • Patients requiring total hysterectomy (with or without bilateral adjuncts or salpingectomy) due to uterine fibroids
  • BMI ranges from 18.5 to 27.9kg/m2;
  • Informed consent signed by the subject himself or his legal representative.

Критерии исключения

  • Pregnant and lactating women;
  • asexual life history, vaginal malformations or adhesions, postmenopausal vaginal atrophy and stenosis;
  • Preoperative examination for malignant possibility
  • Uterine volume ≥20 weeks, history of pelvic inflammatory disease, severe endometriosis, degree III or IV uterine prolapse; Previous surgical history of intestinal obstruction, recurrent pelvic inflammatory disease, pelvic tuberculosis, and pelvic abdominal tumor; Gynecological examination of the uterine and rectal fossa is completely closed;
  • Patients known to have severe hepatic or renal dysfunction;
  • Patients with known blood disorders, coagulation disorders, active bleeding at any site, or bleeding propensity;
  • complicated with serious diseases of central nervous system, cardiovascular system, liver and kidney, digestive tract, respiratory system, endocrine and metabolism (thyroid disease, Cushing\'s syndrome, hyperprolactinemia), skeletal and muscular system and mental disorders;
  • patients with acute infection;
  • Known to have participated in any other clinical trial or taken hormone therapy within 3 months;
  • who cannot sign the informed consent;
  • For those with known or suspected poor compliance who could not complete the trial.

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
Двойное слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • China-Japan Friendship Hospital — Пекин

Идентификаторы

NCT: NCT06658145 · NTCS-vnotesLH

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗