Informazioni generali
  • Categoria della malattia Cancro del polmone , Chirurgia / intervento / operazione (BASEC)
  • Stato di reclutamento reclutamento non ancora iniziato (BASEC/ICTRP)
  • Luogo dello studio
    Basilea
    (BASEC)
  • Responsabile dello studio Didier Lardinois didier.lardinois@usb.ch (BASEC)
  • Fonte dati BASEC: Importato da 16.04.2025 ICTRP: N/A
  • Ultimo aggiornamento 16.04.2025 09:55
HumRes66752 | SNCTP000006367 | BASEC2025-D0025

Comparison of postoperative pain with thin or thick drainage tubes after lung lobe or lung segment removal

  • Categoria della malattia Cancro del polmone , Chirurgia / intervento / operazione (BASEC)
  • Stato di reclutamento reclutamento non ancora iniziato (BASEC/ICTRP)
  • Luogo dello studio
    Basilea
    (BASEC)
  • Responsabile dello studio Didier Lardinois didier.lardinois@usb.ch (BASEC)
  • Fonte dati BASEC: Importato da 16.04.2025 ICTRP: N/A
  • Ultimo aggiornamento 16.04.2025 09:55

Descrizione riassuntiva dello studio

At the end of a lung surgery where a lung lobe or lung segment has been removed, a tube is inserted into the chest (also known as chest drainage). The tube drains wound fluid and air from the chest. The placement of a large-bore tube (24 F) after lung segment removal is currently considered standard procedure. The tube can cause pain and interfere with the patient's breathing exercises. Therefore, according to current understanding, the tube is removed as soon as it is no longer necessary. The tube is usually removed starting from the first postoperative day. In this study, we want to find out whether patients with a small-bore (16 F) tube in the chest experience less postoperative pain. Additionally, we want to investigate pain relief after early removal of the tube. The postoperative complications in patients with early removal of the tube from the chest will be compared with those in whom the tube was removed starting from the first day after surgery.

(BASEC)

Intervento studiato

The study intervention being investigated is the placement of a chest drain with a thin tube following lung surgery. Depending on randomization, either a small-bore (16 F) or a large-bore (24 F) tube will be inserted.

 

Postoperatively, the intensity of chest pain in the surgical area will be measured using the visual analog scale (VAS), which is provided to the patient on a sheet of paper. The visual analog scale is a widely recognized scale.

 

Chest pain intensity will be measured and documented at rest and during coughing. The patient marks their responses with a vertical line on the horizontal marking line of the sheet. The evaluation is done by measuring the distance from the starting anchor point (0) to the marking; the recorded values are documented in millimeters (0-100). Assessment will take place 2, 4, 6 hours after the end of the operation and then daily between 7–8 AM and 5–6 PM until the third day or until the tube is removed.

(BASEC)

Malattie studiate

Resectable non-small cell lung carcinoma. Lung metastases. Lung changes with suspicion of a malignant disease.

(BASEC)

Criteri di partecipazione
Resectable non-small cell lung carcinoma. Lung metastases. Lung changes with suspicion of a malignant disease. Thoracoscopic (=keyhole surgery) anatomical lung segment removal under general anesthesia. (BASEC)

Criteri di esclusione
Previous chest surgeries on the same side within 6 months. Chronic pain. Severe heart, liver, and kidney diseases. Bleeding disorders. Nerve diseases. Chest pain (in the surgical area) when coughing of > 10 mm preoperatively. (BASEC)

Luogo dello studio

Basilea

(BASEC)

non disponibile

Sponsor

University Hospital Basel

(BASEC)

Contatto per ulteriori informazioni sullo studio

Persona di contatto in Svizzera

Didier Lardinois

+41 (0)61 328 77 99

didier.lardinois@usb.ch

University Hospital Basel

(BASEC)

Informazioni scientifiche

non disponibile

Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)

Commissione d'etica svizzera nord-ovest/centrale EKNZ

(BASEC)

Data di approvazione del comitato etico

16.04.2025

(BASEC)


ID di studio ICTRP
non disponibile

Titolo ufficiale (approvato dal comitato etico)
Comparison of 16F versus 24F chest drain after thoracoscopic lobectomy and/or segmentectomy: a monocentre prospective randomized controlled trial. (BASEC)

Titolo accademico
non disponibile

Titolo pubblico
non disponibile

Malattie studiate
non disponibile

Intervento studiato
non disponibile

Tipo di studio
non disponibile

Disegno dello studio
non disponibile

Criteri di inclusione/esclusione
non disponibile

non disponibile

Endpoint primari e secondari
non disponibile

non disponibile

Data di registrazione
non disponibile

Inclusione del primo partecipante
non disponibile

Sponsor secondari
non disponibile

Contatti aggiuntivi
non disponibile

ID secondari
non disponibile

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
non disponibile


Risultati dello studio

Riepilogo dei risultati

non disponibile

Link ai risultati nel registro primario

non disponibile