A randomized controlled pilot trial: Comparison of 14 and 24 French thoracic drainage after minimally invasive lobectomy – MZ 14-24 study
Organizational Data
- DRKS-ID:
- DRKS00029982
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2022-09-15
- Last update in DRKS:
- 2023-05-19
- Registration type:
- Prospective
Acronym/abbreviation of the study
MZ 14-24 Study
URL of the study
No Entry
Brief summary in lay language
The aim of the study is to compare thoracic drains with two different diameters (14 and 24 Charrière) after minimally invasive lobectomy. One of the aims of the pilot study is to be able to perform a case number calculation for a large-scale randomized trial. Study participants will be randomized into 2 groups of 20 subjects. The allocation will take place during surgery. The respective drainage is inserted intraoperatively. It is assumed that the small diameter compared to the control group leads to less pain and therefore fewer postoperative complications. There is a risk of drainage blockage due to blood coagulation. In this case the drainage would have to be flushed with saline. This risk exists with both drainages, but could be increased with a smaller diameter. The further postoperative procedure does not deviate from our standards.
Brief summary in scientific language
It is a randomized prospective pilot study with 40 study participants. The aim of the study is to compare 14Ch and 24Ch chest drains, after minimally invasive lobectomy. One group (with 20 subjects) will use the 14Ch drain at the end of surgery, while the other group (also 20 subjects) will use the 24Ch. These are the approved Medela Helathcare drains. The further postoperative procedure does not deviate from our clinical standards. Removal of the drainage usually takes place on the second postoperative day by a referred physician. The prerequisite for this is that there was no air leak in the previous 24 hours and the volume drainage is less than 5ml/kg/D in non-obese patients (body mass index <30) or less than 300 ml/D in other patients - BMI>30, with renal or cardiac insufficiency. Our hypothesis of the study is based on the fact that a drainage with a smaller diameter leads to reduced postoperative pain and therefore the complication rate of pneumonia etc. is reduced. There is likely an increased risk, compared to the larger diameter drains, for clogging of the drain by blood coagulum. In this case, the drainage would need to be flushed and reopened using saline. However, we consider the risk to be low, since only minor postoperative bleeding occurs with today's minimally invasive surgical procedures.
Health condition or problem studied
- ICD10:
- C34 - Malignant neoplasm of bronchus and lung
- ICD10:
- C78.0 - Secondary malignant neoplasm of lung
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- 20 Patients with a 14 Charrière thoracic drainage
- Arm 2:
- 20 Patients with a 24 Charrière thoracic drainage
Endpoints
- Primary outcome:
- 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 outcome:
- 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.
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Universitäres Thoraxzentrum Mainz Mainz
Recruitment period and number of participants
- Planned study start date:
- 2022-10-03
- Actual study start date:
- 2022-12-06
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 40
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 90 Years
- Additional 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
Addresses
Primary Sponsor
- Address:
- Universitäres Thoraxzentrum MainzHerr Univ.-Prof. Dr. med. FEBTS Eric RößnerLangenbeckstr. 155131 MainzGermany
- Telephone:
- 06131/17-4602
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.unimedizin-mainz.de/utm/das-universitaere-thoraxzentrum-mainz/willkommen.html
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universitäres Thoraxzentrum MainzUniv.-Prof. Dr. med. FEBTS Eric RößnerLangenbeckstr. 155131 MainzGermany
- Telephone:
- 06131/17-4602
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.unimedizin-mainz.de/utm/das-universitaere-thoraxzentrum-mainz/willkommen.html
Contact for Public Queries
- Address:
- Universitäres Thoraxzentrum MainzHerr Univ.-Prof. Dr. med. FEBTS Eric RößnerLangenbeckstr. 155131 MainzGermany
- Telephone:
- 06131/17-4602
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.unimedizin-mainz.de/utm/das-universitaere-thoraxzentrum-mainz/willkommen.html
Principal Investigator
- Address:
- Universitäres Thoraxzentrum MainzUniv.-Prof. Dr. med. FEBTS Eric RößnerLangenbeckstr. 155131 MainzGermany
- Telephone:
- 06131/17-4602
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.unimedizin-mainz.de/utm/das-universitaere-thoraxzentrum-mainz/willkommen.html
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Universitäres Thoraxzentrum MainzLangenbeckstr. 155131 MainzGermany
- Telephone:
- 06131/17-4602
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.unimedizin-mainz.de/utm/das-universitaere-thoraxzentrum-mainz/willkommen.html
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission bei der Landesärztekammer Rheinland-PfalzDeutschhausplatz 355116 MainzGermany
- Telephone:
- +49-6131-288220
- Fax:
- +49-6131-2882266
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2022-06-03
- Ethics committee number:
- 2021-15994
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2022-07-01
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry