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Идёт набор NCT06958848

16F vs 24F Chest Drain After Minimally Invasive Lobectomy and/or Segmentectomy

Без фазы С лечением Pneumothorax Pleural Effusion

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: 16 F chest tube, 24 F chest tube, Early removal, Standard removal.
Кому может быть актуально
Состояния в реестре: Pneumothorax, Pleural Effusion. Базовые параметры: от 18 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
Швейцария
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Comparison of 16F Versus 24F Chest Drain After Minimally Invasive Pulmonary Lobectomy and/or Segmentectomy: a Monocentre Prospective Randomized Controlled Trial

Обзор

The aim of the study is to evaluate postoperative pain in patients receiving a small-bore (16F) chest drain compared to those receiving the standard large-bore (24F) chest drain after minimally invasive pulmonary lobectomy and/or segmentectomy.

Подробное описание

Lung cancer remains the leading cause of cancer-related death worldwide, and surgical resection remains the treatment of choice for patients with resectable non-small cell lung cancer (NSCLC), particularly in early stages of the disease. Anatomical lung resections such as lobectomy and segmentectomy are commonly performed, increasingly through minimally invasive techniques like video-assisted thoracoscopic surgery (VATS) and robotic-assisted thoracoscopic surgery (RATS). Compared to traditional thoracotomy, VATS and RATS has been associated with better postoperative outcomes, including less pain, shorter hospital stays, faster recovery, and improved quality of life.

After lung resections, the standard postoperative management involves the insertion of a chest drain to remove air and fluid from the pleural space and monitor for complications such as air leaks or bleeding. Traditionally, most thoracic surgery centres use a single large-bore chest tube, typically 24F in size, which remains in place at least until the first postoperative day. However, this practice is not based on strong evidence, and there is currently no consensus on the optimal size of the chest drain. In fact, removal of the chest tube has been shown to significantly improve ventilatory function and reduce pain, particularly in the early postoperative period.

The Chest Drain 16F vs 24F Study investigates whether the use of a smaller-bore chest drain (16F) leads to less postoperative pain compared to the standard large-bore 24F drain in patients undergoing minimally invasive pulmonary lobectomy and/or segmentectomy. In addition to comparing the tube sizes, the trial explores the safety and feasibility of early chest drain removal, defined as removal within 2 to 6 hours after surgery, provided that specific clinical criteria are met (e.g., minimal air leak and no signs of complications). While retrospective data and small prospective studies suggest that early removal and the use of smaller tubes may be beneficial, high-quality prospective data are lacking. This study aims to provide evidence to potentially change clinical practice by reducing patient discomfort without compromising safety.

Вмешательства

  • Устройство 16 F chest tube
    Insertion of 16F chest tube
  • Устройство 24 F chest tube
    Insertion of 24F chest tube
  • Процедура Early removal
    Removal 2-6h after end of skin closure
  • Процедура Standard removal
    Removal 1day postoperative

Первичные конечные точки

  • Postoperative chest pain [Срок оценки: 4 and 6 hours after last suture; twice daily from day 1 to day 3 postoperative or until tube removal; on discharge home; on follow up day 30 and 180.]
  • Postoperative acute pain relief while coughing [Срок оценки: 4 and 6 hours after last suture; twice daily from day 1 to day 3 postoperative or until tube removal; on discharge home; on follow up day 30 and 180.]
Вторичные конечные точки (11)
  • Postoperative acute pain relief at rest [Срок оценки: 4 and 6 hours after last suture; twice daily from day 1 to day 3 postoperative or until tube removal; on discharge home; on follow up day 30 and 180.]
  • Analgesia consumption [Срок оценки: 4 and 6 hours after last suture; twice daily from day 1 to day 3 postoperative or until tube removal; on discharge home; on follow up day 30 and 180.]
  • Duration of the thoracic drainage [Срок оценки: From 2 until 6 hours after last suture; twice daily from day 1 until the chest tube is removed.]
  • Fluid output [Срок оценки: From 2 until 6 hours after last suture; twice daily from day 1 until the chest tube is removed.]
  • Length of hospital stay [Срок оценки: Patients are discharged from hospital on the 3rd to 7th day, or stay up to the 10th day in case of prolonged air leak or re-operation.]
  • Re-hospitalization [Срок оценки: After hospital discharge until 180-day follow up.]
  • Postoperative morbidity [Срок оценки: During hospitalization and follow up until 30-day follow up.]
  • Pleural complications [Срок оценки: During hospitalization and follow up until 30-day follow up.]
  • Mortality [Срок оценки: During hospitalization; 30 and 180 days after hospital discharge.]
  • Chronic pain [Срок оценки: 30 and 180 days after hospital discharge.]
  • Quality of life assessment [Срок оценки: Preoperative and at 30/180-day follow up.]

Критерии участия

Критерии включения

  • Informed Consent signed by the patient (all sex and gender)
  • Patients' age from ≥ 18 to no age limit at time of study inclusion
  • American Society of Anaesthesiologists (ASA) physical status classification I to IV
  • Patients with resectable non-small cell lung cancer (NSCLC) deemed operable by minimally invasive surgical technique.
  • Minimally invasive anatomical lung resections under general anaesthesia: lobectomy, lobectomy with wedge resection, lobectomy combined with segmentectomy, segmentectomy with wedge resection, bilobectomy

Критерии исключения

  • Previous thoracic surgery on the same side within 3 months
  • Lung cancer complicated with pleural empyema
  • Patients with chronic pain who receive opioids/gabapentin/pregabalin
  • Patients who consume opiates/benzodiazepines
  • Congestive heart failure NYHA Class III or IV
  • Liver cirrhosis Child-Pugh Class B and C
  • Renal insufficiency requiring dialysis and/or estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2
  • Patients with coagulopathy or bleeding disorders: von Willebrand disease, Hemophilia; Thrombocytopenia (<50 G/l), requiring platelet transfusion
  • Patients with neuralgia
  • Chest pain (site of surgery) without taking painkillers, measured by VAS while coughing > 10 mm
  • Not consolidated rib fractures (in the last 3 months) on the side of surgical procedure
  • Open anatomical lung resection, including pneumonectomy
  • Insertion of 2 or more chest tubes
  • Need for patient controlled intravenous anaesthesia or patient controlled epidural anaesthesia
  • Patients intubated/sedated (not suitable due to difficulties to fill out the pain survey)

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
Простое слепое
Основная цель
Лечение

Центры проведения

Швейцария · 1 центр
  • University Hospital Basel — Basel

Идентификаторы

NCT: NCT06958848 · 2025-D0025; kt25Lardinois2

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗