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Набор скоро начнётся NCT06828419

A Clinical Study on the Feasibility and Safety of Abdominal Endoscopic Single-port Surgery System to Assist Gynecological Day Surgery

Без фазы С лечением Adenopathy Uterine Fibroids Ovarian Cysts Adnexal Mass

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: Domestic single-port laparoscopic surgery system.
Кому может быть актуально
Состояния в реестре: Adenopathy, Uterine Fibroids, Ovarian Cysts, Adnexal Mass. Базовые параметры: 18 лет — 75 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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Обзор

In this study, a prospective study is used to select patients who will undergo intra-abdominal endoscopic single-port surgery system for benign gynecological diseases from February 2025 to December 2026 in the Second Affiliated Hospital of Wenzhou Medical University, including hysterectomy, myomectomy, ovarian cyst removal and adnexectomy. The study will perform statistical analysis to evaluate the feasibility and the main factors affecting the safety of intra-abdominal endoscopic single-port surgery system(SR-ENS-600) used in gynecological day surgery.

Вмешательства

  • Устройство Domestic single-port laparoscopic surgery system
    The minimum distance of the single-port surgical system from the port is 5-7cm to obtain the instrument bending space. The load capacity of surgical tools is increased from 2N to 5N, which greatly improves the structural reliability. At the same time, it can realize 6 degrees of freedom movement。

Первичные конечные точки

  • Day Surgery Success Rate [Срок оценки: Patient recruitment ends and all patients complete surgery, up to 2 years]
Вторичные конечные точки (12)
  • Time of Operation [Срок оценки: From pre-surgery to the end of surgery，up to 12 hours]
  • Blood Loss Evaluation [Срок оценки: From the time of hemoglobin measurement before surgery to the time of hemoglobin measurement after surgery, up to 1 day after surgery]
  • Surgeon Satisfaction Evaluation [Срок оценки: Up to 1 day after surgery]
  • Time of First Postoperative Anal Exhaust [Срок оценки: Up to 2 day after surgery]
  • First Spontaneous Urination Time [Срок оценки: Up to 2 day after surgery]
  • Pain Score [Срок оценки: 4 hours after surgery]
  • Hospital Stays [Срок оценки: From the date of admission to the Date of discharge, assessed up to 2 days]
  • Postoperative Rehabilitation Evaluation [Срок оценки: Within 1 day after surgery; 24 hours and 30 days after discharge]
  • Abdominal Incision Healing [Срок оценки: Within 1 day after surgery]
  • Scar Satisfaction [Срок оценки: 30 days after discharge]
  • Discharge Assessment [Срок оценки: Within 1 day after surgery, 4 hours after discharge]
  • Postoperative Complication [Срок оценки: 4 hours, 24 hours and 30 days after discharge]

Критерии участия

Критерии включения

  • Women aged 18 to 75 years old, with a body mass index (BMI) of no more than 32 kg/m2;
  • Conscious, no history of mental illness, accompanied by an adult during the perioperative period;
  • Educate the subjects, who are willing to undergo day surgery, understand and accept the surgical method and anesthesia method;
  • Subjects and families understand perioperative care and are willing and able to complete post-discharge care;
  • Elective surgery, no serious complications affecting the operation and prognosis, aCCI age adjusted comorbidity index 0 points;
  • According to the adhesion risk scoring system of European Anti-Adhesions in Gynaecology Expert Panel (ANGEL), the adhesion risk was divided into three levels: high, medium and low. Subjects with low risk (0 to 12 points) and abdominal wall scarring and pelvic cavity B-ultrasonography do not indicate obvious pelvic cavity adhesion wiil be included.

Критерии исключения

  • Moderate and high-risk patients will be excluded based on ANGEL adhesion risk scoring system;
  • Subjects with hemorrhagic rupture of ectopic pregnancy and unstable vital signs;
  • Genital tract infection or in the acute phase of systemic infection;
  • Subjects on long-term anticoagulant therapy or with coagulation dysfunction;
  • Subjects have severe heart and lung disease, liver and kidney dysfunction, and cannot tolerate anesthesia;
  • A history of abdominal or diaphragmatic hernia, abnormal umbilical cord development, or umbilical surgery;
  • Not willing to undergo endoscopic surgery;
  • Participated in other drug and device clinical trials within 3 months before surgery.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Другое

Центры проведения

Китай · 1 центр
  • Second Affiliated Hospital of Wenzhou Medical University — Wenzhou

Идентификаторы

NCT: NCT06828419 · SAHoWMU-CR2024-07-124

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗