People's Hospital of Xinjiang Uygur Autonomous Region
Objective: To evaluate the impact of enhanced recovery after surgery (ERAS)-based nursing intervention on venous thromboembolism (VTE) and lymphedema after radical hysterectomy for cervical cancer.
Methods: In this prospective randomized controlled trial, 160 patients scheduled for radical hysterectomy during September 2022-September 2024 were randomized to an ERAS group (n = 80) or a control group (n = 80). The control group received conventional perioperative care, while the ERAS group received a multimodal perioperative care protocol. Primary outcomes were the 6-month incidence of VTE and lower limb lymphedema. Secondary outcomes included recovery indicators, inflammatory and coagulation markers, quality of life [QoL; assessed by the Quality of Life Questionnaire-Core 30 (QLQ-C30)], and nursing satisfaction.
Обзор исследования
Статус
Вмешательство/лечение
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Xinjiang Uygur Autonomous Region
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Ürümqi, Xinjiang Uygur Autonomous Region, Китай, 830000
- People's Hospital of Xinjiang Uygur Autonomous Region
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- . Pathologically confirmed cervical cancer (FIGO 2018) 2. Age 18-70 years 3. First-time radical hysterectomy 4. ASA physical status class I-II 5. Perioperative anticoagulant prophylaxis per hospital standards 6. Provision of informed consent
Exclusion Criteria:
- 1. Pre-existing lower extremity DVT, lymphedema, or severe varicose veins 2. Severe cardiac, hepatic, or renal dysfunction or coagulation disorders 3. History of psychiatric illness or communication barriers 4. Pregnant or lactating women
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Без вмешательства: Conventional Perioperative Care
The control group received conventional perioperative care.
This included routine preoperative education, fasting for 12 hours and no oral intake for 6 hours preoperatively, standard intraoperative fluid administration, postoperative patient-controlled analgesia pump, ambulation guided by traditional instructions (typically 1-2 days postoperatively), and initiation of liquid diet after passing flatus.
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Экспериментальный: ERAS Multimodal Pathway
In addition to conventional care, the ERAS group received a comprehensive intervention protocol based on ERAS principles, implemented by a dedicated ERAS nursing team. Details are as follows: Preoperative interventions: (1) Enhanced education and prehabilitation: Detailed explanation of the ERAS pathway, VTE and lymphedema prevention using graphics and videos. Instruction on ankle pump exercises and quadriceps isometric contractions. (2) Nutritional support: Nutritional risk assessment and provision of oral nutritional supplements if necessary. (3) Fasting management: No solid food for 6 hours, clear oral fluids (e.g., 200 mL of 10% glucose solution) allowed up to 2 hours preoperatively. Intraoperative interventions: (1) Thermoregulation: Use of forced-air warming blankets and fluid warmers to maintain core temperature > 36°C. (2) Restrictive fluid management: Goal-directed fluid therapy to avoid excessive infusion. (3) Minimally invasive and meticulous surgery: Encouragement of lapar |
In addition to conventional care, the ERAS group received a comprehensive intervention protocol based on ERAS principles, implemented by a dedicated ERAS nursing team. Details are as follows: Preoperative interventions: (1) Enhanced education and prehabilitation: Detailed explanation of the ERAS pathway, VTE and lymphedema prevention using graphics and videos. Instruction on ankle pump exercises and quadriceps isometric contractions. (2) Nutritional support: Nutritional risk assessment and provision of oral nutritional supplements if necessary. (3) Fasting management: No solid food for 6 hours, clear oral fluids (e.g., 200 mL of 10% glucose solution) allowed up to 2 hours preoperatively. Intraoperative interventions: (1) Thermoregulation: Use of forced-air warming blankets and fluid warmers to maintain core temperature > 36°C. (2) Restrictive fluid management: Goal-directed fluid therapy to avoid excessive infusion. (3) Minimally invasive and meticulous surgery: Encouragement of laparo |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Incidence of Postoperative Venous Thromboembolism (VTE)
Временное ограничение: 6 months after surgery
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Composite incidence of deep vein thrombosis (DVT) of the lower extremities and pulmonary embolism (PE).
DVT is diagnosed by bilateral lower extremity venous color Doppler ultrasonography performed on postoperative day 3, before discharge, and at 1, 3, and 6 months postoperatively or when clinically indicated.
PE is evaluated by computed tomography pulmonary angiography (CTPA) when clinically suspected.
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6 months after surgery
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Incidence of Postoperative Lower Limb Lymphedema
Временное ограничение: 6 months after surgery
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Diagnosis based on International Society of Lymphology criteria (Grade I: pitting edema relieved by elevation; Grade II: non-pitting edema with tissue fibrosis; Grade III: elephantiasis).
Measured by bilateral calf circumference (thickest point) and thigh circumference (15 cm above patella).
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6 months after surgery
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Time to First Flatus
Временное ограничение: Within 14 days after surgery (typically hours to days)
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Number of hours from surgery completion to first passage of flatus, indicating recovery of gastrointestinal function.
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Within 14 days after surgery (typically hours to days)
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Time to First Defecation
Временное ограничение: Within 14 days after surgery (typically days)
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Number of hours from surgery completion to first bowel movement.
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Within 14 days after surgery (typically days)
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Time to First Ambulation
Временное ограничение: Within 7 days after surgery
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Number of days from surgery completion to the first time the patient walks independently (assisted or unassisted) outside the bed area.
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Within 7 days after surgery
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Postoperative Length of Hospital Stay
Временное ограничение: At hospital discharge, assessed up to 4 weeks postoperatively
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Total number of days from the date of surgery to the date of hospital discharge.
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At hospital discharge, assessed up to 4 weeks postoperatively
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Change in C-Reactive Protein (CRP)
Временное ограничение: Preoperative (baseline) vs. Postoperative day 3
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Change in serum C-reactive protein (CRP) measured from fasting blood samples, reported in mg/L.
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Preoperative (baseline) vs. Postoperative day 3
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Change in D-Dimer (D-D)
Временное ограничение: Preoperative (baseline) vs. Postoperative day 3
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Change in plasma D-dimer (D-D) measured from fasting blood samples, reported in mg/L.
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Preoperative (baseline) vs. Postoperative day 3
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Change in Platelet Count (PLT)
Временное ограничение: Preoperative (baseline) vs. Postoperative day 3
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Change in platelet count (PLT) measured from complete blood count, reported in ×10⁹/L.
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Preoperative (baseline) vs. Postoperative day 3
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Change in Global Health Status / Quality of Life (QLQ-C30)
Временное ограничение: Preoperative (baseline) vs. 6 months postoperatively
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Change in the Global Health Status / Quality of Life subscale score from the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).
Minimum value: 0. Maximum value: 100.
Higher scores indicate better quality of life.
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Preoperative (baseline) vs. 6 months postoperatively
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Nursing Satisfaction
Временное ограничение: At hospital discharge (postoperative day 7 to day 15)
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Measured by the Newcastle Satisfaction with Nursing Scale (NSNS).
Categorized as: highly satisfied, moderately satisfied, or not satisfied.
Overall satisfaction rate = (highly satisfied + moderately satisfied) / total patients × 100%.
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At hospital discharge (postoperative day 7 to day 15)
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Change in White Blood Cell Count (WBC)
Временное ограничение: Preoperative (baseline) vs. Postoperative day 3
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Change in white blood cell count (WBC) measured from fasting blood samples, reported in ×10⁹/L.
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Preoperative (baseline) vs. Postoperative day 3
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Change in Prothrombin Time (PT)
Временное ограничение: Preoperative (baseline) vs. Postoperative day 3
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Change in prothrombin time (PT) measured from fasting blood samples, reported in seconds.
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Preoperative (baseline) vs. Postoperative day 3
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Change in Hemoglobin (Hb)
Временное ограничение: Preoperative (baseline) vs. Postoperative day 3
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Change in hemoglobin (Hb) measured from complete blood count, reported in g/L.
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Preoperative (baseline) vs. Postoperative day 3
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Change in Functional Scales (QLQ-C30)
Временное ограничение: Preoperative (baseline) vs. 6 months postoperatively
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Change in the Functional Scales composite score from the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).
Minimum value: 0. Maximum value: 100.
Higher scores indicate better functional status.
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Preoperative (baseline) vs. 6 months postoperatively
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Change in Symptom Scales (QLQ-C30)
Временное ограничение: Preoperative (baseline) vs. 6 months postoperatively
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Change in the Symptom Scales composite score from the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).
Minimum value: 0. Maximum value: 100.
Higher scores indicate worse symptom burden.
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Preoperative (baseline) vs. 6 months postoperatively
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Change in Single Items (QLQ-C30)
Временное ограничение: Preoperative (baseline) vs. 6 months postoperatively
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Change in the Single Items score (including dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties) from the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).
Minimum value: 0. Maximum value: 100.
Higher scores indicate worse symptom burden or greater financial difficulty.
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Preoperative (baseline) vs. 6 months postoperatively
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Change in Total Score (QLQ-C30)
Временное ограничение: Preoperative (baseline) vs. 6 months postoperatively
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Change in the total score from the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).
Minimum value: 0. Maximum value: 100.
Higher scores indicate better overall quality of life.
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Preoperative (baseline) vs. 6 months postoperatively
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Соавторы и исследователи
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
- Урогенитальные заболевания
- Генитальные заболевания
- Сосудистые заболевания
- Сердечно-сосудистые заболевания
- Урогенитальные новообразования
- Новообразования по локализации
- Новообразования
- Женские урогенитальные заболевания
- Женские мочеполовые заболевания и осложнения беременности
- Заболевания матки
- Заболевания половых органов, Женский
- Эмболия и тромбоз
- Генитальные Новообразования, Женщины
- Лимфатические заболевания
- Заболевания шейки матки
- Новообразования матки
- Тромбоэмболия
- Гемики и лимфатические заболевания
- Лимфедема
- Новообразования шейки матки
- Венозная тромбоэмболия
Другие идентификационные номера исследования
- KY2022080503
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .