Informations générales
  • Catégorie de maladie Cancer du poumon , Chirurgie (BASEC)
  • État du recrutement recrutement pas encore commencé (BASEC/ICTRP)
  • Lieu de l’étude
    Bâle
    (BASEC)
  • Responsable de l'étude Didier Lardinois didier.lardinois@usb.ch (BASEC)
  • Source(s) de données BASEC: Importé de 16.04.2025 ICTRP: N/A
  • Date de mise à jour 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

  • Catégorie de maladie Cancer du poumon , Chirurgie (BASEC)
  • État du recrutement recrutement pas encore commencé (BASEC/ICTRP)
  • Lieu de l’étude
    Bâle
    (BASEC)
  • Responsable de l'étude Didier Lardinois didier.lardinois@usb.ch (BASEC)
  • Source(s) de données BASEC: Importé de 16.04.2025 ICTRP: N/A
  • Date de mise à jour 16.04.2025 09:55

Résumé de l'étude

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)

Intervention étudiée

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)

Maladie en cours d'investigation

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

(BASEC)

Critères de participation
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)

Critères d'exclusion
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)

Lieu de l’étude

Bâle

(BASEC)

non disponible

Sponsor

University Hospital Basel

(BASEC)

Contact pour plus d'informations sur l'étude

Personne de contact en Suisse

Didier Lardinois

+41 (0)61 328 77 99

didier.lardinois@usb.ch

University Hospital Basel

(BASEC)

Informations scientifiques

non disponible

Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)

Ethikkommission Nordwest- und Zentralschweiz EKNZ

(BASEC)

Date d'approbation du comité d'éthique

16.04.2025

(BASEC)


Identifiant de l'essai ICTRP
non disponible

Titre officiel (approuvé par le comité d'éthique)
Comparison of 16F versus 24F chest drain after thoracoscopic lobectomy and/or segmentectomy: a monocentre prospective randomized controlled trial. (BASEC)

Titre académique
non disponible

Titre public
non disponible

Maladie en cours d'investigation
non disponible

Intervention étudiée
non disponible

Type d'essai
non disponible

Plan de l'étude
non disponible

Critères d'inclusion/exclusion
non disponible

non disponible

Critères d'évaluation principaux et secondaires
non disponible

non disponible

Date d'enregistrement
non disponible

Inclusion du premier participant
non disponible

Sponsors secondaires
non disponible

Contacts supplémentaires
non disponible

ID secondaires
non disponible

Résultats-Données individuelles des participants
non disponible

Informations complémentaires sur l'essai
non disponible


Résultats de l'essai

Résumé des résultats

non disponible

Lien vers les résultats dans le registre primaire

non disponible