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Идёт набор NCT06250699

A Single Center Randomized Controlled Study on the Promotion of Rapid Recovery

Без фазы С лечением Nonfunctional Adrenal Cortex Adenoma Primary Aldosteronism Cushing Syndrome

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: Tubeless laparoscopic adrenalectomy, Drainage tube.
Кому может быть актуально
Состояния в реестре: Nonfunctional Adrenal Cortex Adenoma, Primary Aldosteronism, Cushing Syndrome. Базовые параметры: 18 лет — 70 лет · Все.
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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Single Center Randomized Controlled Study on the Promotion of Rapid Recovery Through Tubeless Laparoscopic Adrenalectomy

Обзор

The goal of this clinical trial is to exploring the role of tubeless after adrenalectomy surgery. The main questions it aims to answer are: 1. The safety of tubeless laparoscopic adrenalectomy； 2. The role of tubeless therapy in rapid recovery after adrenalectomy surgery Participants will be randomly divided into two groups: the non drainage group and the drainage group after laparoscopic adrenal surgery, and their pain, first time out of bed, and intestinal recovery time will be observed.

Подробное описание

The design type of this study is a prospective single center randomized controlled study, with a plan to recruit 200 patients who underwent laparoscopic adrenalectomy for the study. The intervention measures mainly include whether to indwelling drainage tubes. Prior to the start of the trial, our center had performed laparoscopic adrenalectomy on 89 patients without any obvious retroperitoneal fluid accumulation, redness, swelling, or fever, and the recovery was smooth. Step 1 of the research: Select patients who meet the criteria for laparoscopic adrenalectomy Step 2: Sign informed consent form Step 3: Randomly draw lots and divide them into two groups: no tube group (experimental group of 100 cases) and indwelling drainage tube group (control group of 100 cases) Step 4: Perform surgical plan according to grouping results Step 5: Test blood routine and ERAS related indicators 1-3 days after surgery Step 6: Follow up adrenal ultrasound at 1 month and 6 months after surgery Step 7: Follow up and analyze data Random plan Use block randomization method, using software SAS9.4 TS1M7, random seed number 2023092311 Observation items and testing time points 1. Test hemoglobin and drainage volume on 1-3 days after surgery Pain score, first time out of bed, intestinal ventilation time, adrenal ultrasound, postoperative fever, wound infection, and other indicators; During the follow-up one month after surgery, the adrenal region color ultrasound should also be tested; 3. During the follow-up examination at 6 months after surgery, ultrasound of the adrenal region should also be detected; Efficacy evaluation criteria and effectiveness evaluation methods: Whether the indwelling drainage tube has a promoting effect on the patient's rapid recovery (such as pain score, first time out of bed, intestinal ventilation time, etc.). Safety evaluation methods mainly include the subject's blood routine and vital signs.

Вмешательства

  • Процедура Tubeless laparoscopic adrenalectomy
    No drainage tube placed after laparoscopic adrenalectomy
  • Процедура Drainage tube
    Placing drainage tubes after laparoscopic adrenalectomy

Первичные конечные точки

  • Pain score [Срок оценки: 1-3 days after surgery]
  • First time up and about [Срок оценки: 1-3 days after surgery]
  • Recovery time of intestinal function [Срок оценки: 1-3 days after surgery]
  • Hematoma [Срок оценки: 1-3 days after surgery]
Вторичные конечные точки (1)
  • fever [Срок оценки: 1-3 days after surgery]

Критерии участия

Критерии включения

  • According to the 2022 edition of the Chinese Guidelines for Diagnosis and Treatment of Urological Diseases, patients who meet the surgical indications
  • The patient has signed an informed consent form before joining the clinical trial, and the age at the time of signing the informed consent form is 18-70 years old.

Критерии исключения

  • Patients with complications that seriously affect treatment or quality of life
  • The patient has any physical condition that the researcher believes will affect the clinical status
  • Patients who have placed vascular stents such as heart and cerebrovascular stents within the past year
  • Pregnant or lactating patients

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
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Zhongnan hospital — Ухань

Публикации

  • Chai S, Pan Q, Liang C, Zhang H, Xiao X, Li B. Should surgical drainage after lateral transperitoneal laparoscopic adrenalectomy be routine?-A retrospective comparative study. Gland Surg. 2021 Jun;10(6):1910-1919. doi: 10.21037/gs-20-829. PMID 34268075
  • Lelli G, Micalizzi A, Iossa A, Fassari A, Concistre A, Circosta F, Petramala L, De Angelis F, Letizia C, Cavallaro G. Application of enhanced recovery after surgery (ERAS) protocols in adrenal surgery: A retrospective, preliminary analysis. J Minim Access Surg. 2024 Apr 1;20(2):163-168. doi: 10.4103/jmas.jmas_319_22. Epub 2023 May 10. PMID 37282440

Идентификаторы

NCT: NCT06250699 · 2023231

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗