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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00029982
Enrollment
40
Registered
2022-09-15
Start date
2022-12-06
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C34 C78.0

Interventions

Group 1: 20 Patients with a 14 Charrière thoracic drainage Group 2: 20 Patients with a 24 Charrière thoracic drainage

Sponsors

Universitäres Thoraxzentrum Mainz
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
Secondary target parameter: 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.

Countries

Germany

Contacts

Public ContactEric Rößner

Universitäres Thoraxzentrum Mainz

utm@unimedizin-mainz.de06131/17-4602

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 9, 2026