Removal of thoracic drainage after thoracic surgical minor procedures immediately following the operation
Résumé de l'étude
The management of thoracic drainage after thoracic procedures is a key element of postoperative care. Over the last decade, minimally invasive techniques and standardized treatment pathways (keyword 'ERAS' (enhanced recovery after surgery)) have significantly altered the recovery phase after lung procedures, leading to a reduction in postoperative complications and an increase in quality of life. Thoracic drainage remains a significant issue as it contributes to postoperative pain and worsens lung function. Therefore, there is increased interest in earlier removal of thoracic drains, not only for economic reasons but also for improved quality of life and potential reduction of postoperative complications. Meanwhile, improved drainage systems have been developed that allow for more precise quantification and contribute to increased decision-making certainty regarding drainage removal. Nevertheless, drainage remains in current practice until at least the first day after surgery, even in the absence of indications of incomplete lung or chest wall healing (absence of air leakage or increased or bloody fluid secretion) and limits the patient's mobility and well-being during this time. In this study, we investigate the safety of removing thoracic drainage immediately after surgery in the absence of reasons for inadequate lung or tissue healing (no air leakage and no increased or bloody drainage quality) based on a protocol with the electronic drainage system.
(BASEC)
Intervention étudiée
Removal of thoracic drainage after thoracic surgical minor procedures such as extra-anatomical lung resections and biopsies of the pleura immediately following the operation
(BASEC)
Maladie en cours d'investigation
For complete re-expansion of the lung and for drainage of excessive fluid, after minimally invasive (thoracoscopy) and open lung procedures, as well as other procedures in the thoracic cavity, one or more thoracic drains ('chest drain') are inserted before closing the wounds. The removal of these drains has so far been decided in the further course after surgery according to, for example, the air-tightness of the lung and the amount of drained fluid.
(BASEC)
1. Non-anatomical lung resection (also 'lung biopsy') in camera technique (thoracoscopy) 2. Biopsy of the pleura in camera technique (thoracoscopy) 3. Signed consent 4. Legal age (BASEC)
Critères d'exclusion
1. Anatomical lung resections 2. Pleural empyema (= inflammation / pus between the lung and chest wall) 3. Surgical treatment and evaluation of fluid in the space between the lung and chest wall 4. Pleurodesis (= chemical adhesion of lung to chest wall) in camera technique 5. Vulnerable persons pregnancy, not reached legal age (BASEC)
Lieu de l’étude
Berne
(BASEC)
Sponsor
non disponible
Contact pour plus d'informations sur l'étude
Informations générales
Chief, Department of General Thoracic Surgery, Inselspital
0041 31 632 37 45;0041 31 632 37 45;
patrick.dorn@clutterinsel.ch(ICTRP)
Informations générales
Chief, Department of General Thoracic Surgery, Inselspital
0041 31 632 37 450041 31 632 37 45
patrick.dorn@clutterinsel.ch(ICTRP)
Informations scientifiques
Chief, Department of General Thoracic Surgery, Inselspital
0041 31 632 37 45;0041 31 632 37 45;
patrick.dorn@clutterinsel.ch(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique de Berne
(BASEC)
Date d'approbation du comité d'éthique
01.04.2021
(BASEC)
Identifiant de l'essai ICTRP
NCT04670523 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
non disponible
Titre académique
Early Postoperative Day 0 Chest Tube Removal After Thoracoscopic Minor Surgeries. A Randomized Controlled Clinical Trial. (ICTRP)
Titre public
Early Postoperative Day 0 Chest Tube Removal After Thoracoscopic Minor Surgeries (ICTRP)
Maladie en cours d'investigation
Lung Pathologies of Unclear Etiology (ICTRP)
Intervention étudiée
Procedure: Early postoperative day 0 (POD 0) chest tube removal.Procedure: Chest tube removal according to traditional standard protocol not earlier than on postoperative day 1 (POD 1). (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)
Critères d'inclusion/exclusion
Inclusion Criteria:
1. Thoracoscopic extra-anatomical lung resection (surgical lung biopsy)
2. Thoracoscopic pleural biopsy
3. Signed consent
4. Age of majority
Exclusion Criteria:
1. Anatomical resection
2. Empyema
3. Pleural effusion
4. Pleurodesis
5. Vulnerable persons (Pregnant women, Children and adolescents) (ICTRP)
non disponible
Critères d'évaluation principaux et secondaires
1. Pneumothorax requiring chest tube reinsertion;2. Pleural effusion requiring thoracocentesis;3. Prolonged air leak > 5 days;4. Re-admission or reoperation due to pleural complication (ICTRP)
1. Cardiopulmonary complications (Pneumonia, Atrial fibrillation, ARDS);2. Re-operation;3. Length of drainage (days);4. Length of stay (days) (ICTRP)
Date d'enregistrement
27.11.2020 (ICTRP)
Inclusion du premier participant
non disponible
Sponsors secondaires
non disponible
Contacts supplémentaires
Patrick Dorn, PD;Patrick Dorn, PD;Patrick Dorn, PD, patrick.dorn@insel.ch, 0041 31 632 37 45;0041 31 632 37 45;, Chief, Department of General Thoracic Surgery, Inselspital (ICTRP)
ID secondaires
EROCT (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT04670523 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible