A randomized controlled pilot trial: Comparison of 14 and 24 French thoracic drainage after minimally invasive lobectomy – MZ 14-24 study

Not Applicable

Recruiting

Conditions: C34
C78.0
Malignant neoplasm of bronchus and lung
Secondary malignant neoplasm of lung

Registration Number: DRKS00029982

Lead Sponsor: niversitäres Thoraxzentrum Mainz

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

Inclusion criteria are all patients over 18 years who are targeted for anatomic lobectomy using a minimally invasive technique, regardless of whether the lesion is benign, primary bronchial carcinoma, or pulmonary metastasis from another primary.

Written informed consent from patients is assumed.
Also included will be patients who undergo subsequent lobectomy after an intraoperative frozen section (wedge resection/segmental resection).

Exclusion Criteria

The following subjects were excluded:
- No lobectomy using minimally invasive technique (wedge resection extension, bilobectomy/pneumonectomy, conversion thoracotomy).
- Creation of a 2nd trocar access
- History of congenital/acquired coagulopathy
- Use of direct oral anticoagulants
- Intraoperative evidence of severe adhesions (adhesions involving a complete lobe of the lung that is not resected. Large, wide adhesions that must be released using sharp dissection).
- Deviation from standard postoperative pain management regimen (patient refusal of paravertebral catheter/pain medication).
- Chronic analgesic therapy

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary target parameters:<br>The following parameters will be recorded:<br>- Pain in the first three days postoperatively twice daily (BID).<br>- drainage time<br>- length of hospital stay<br>- Reintervention: irrigation of the drain, repositioning of the drain, placement of an additional drain, re-VATS, placement of a new drain after previous drainage.<br>- Number and type of postoperative complications (e.g., pneumonia, atrial fibrillation, urinary tract inflammation, etc.).

Secondary Outcome Measures

Name	Time	Method
Secondary target parameter:<br>The above parameters are collected with patient data routinely obtained during the inpatient stay (medical record). This includes, but is not limited to: type of surgery (which flap), previous disease profile, laboratory parameters, and pre- and postoperative radiological and clinical findings.