Chest TubesNCT04718272
Safety and Feasibility of the Application of Thoracic Puncture Tube After Pulmonary Lobectomy
A study testing thoracic drainage management in people with Chest Tubes and Pneumonectomy, run by Fujian Medical University Union Hospital at 1 site in China.
Trial summary
There have been several reports on the feasibility of a no-drain policy after pneumonectomy, but the policy is not widely accepted because silent massive hemorrhage, delayed air leaks, and chylothorax would always be major worries for thoracic surgeons, and all of the researches were retrospective case studies with… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chest Tubes, Pneumonectomy, Minimally Invasive Surgery
- What is being tested?
- thoracic drainage management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 25 Jan 2021to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age and gender: 18-70 years old, male and female unlimited;
- Cardiopulmonary function can tolerate operation;
- Primary non-small cell lung cancer was diagnosed by preoperative or intraoperative pathology. The surgical ranges are uni-portal VATS lobectomy with or without mediastinal lymph node dissection or sampling. In cases with multiple nodules in other lobes of the same side, small wedge resections are allowed;
- No air leakage was observed intraoperatively. Meanwhile, after operation, there are also no air leakage observed in water seal bottle when patients are changed from lateral decubitus to horizontal position.
- Patients and their family members can understand and are willing to participate in this clinical study and sign the informed consent..
Who cannot join
- Patients with a severe emphysema or pulmonary bullae;
- Patients with a history of chemotherapy or chemo-radiotherapy;
- Patients with a history of chest surgery;
- Extensive thoracic adhesion ;
- A history of serious mental illness;
- Patients with other conditions considered by the researcher should not participate in the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Guobing Xu, MD, 15880005394, 15880005394@163.com
Chun Chen, MD, 13365910325, chenchun0209@163.com
About this study
Official title: Safety and Feasibility of the Application of Thoracic Puncture Tube VS Combination of Puncture Tube and Silicone Tube After Uniportal VATS Pulmonary Lobectomy
There have been several reports on the feasibility of a no-drain policy after pneumonectomy, but the policy is not widely accepted because silent massive hemorrhage, delayed air leaks, and chylothorax would always be major worries for thoracic surgeons, and all of the researches were retrospective case studies with small sample size and insufficient evidence. Therefore, the purpose of this study is to to evaluate safety and feasibility of an improved policy, the application of a small thoracic puncture tube after pulmonary lobectomy.
Read the detailed description
This study will be accepted in patients with uniportal VATS(Video-assisted Thoracoscopic Surgery）lobetomy. A randomized controlled study protocol will be used, and The patients will be devided into two groups: experimental group for the application of a small thoracic puncture tube and control group for the application of Combination of the puncture tube and traditional silicone tube. The intraoperative conditions, postoperative recovery and the incidence of perioperative complications will be compared. The safety and feasibility of the application of the small thoracic puncture tube after pulmonary lobectomy will be evaluated.
- Conditions
- Chest Tubes, Pneumonectomy, Minimally Invasive Surgery
- Being tested
- thoracic drainage management
- Keywords
- Chest Tubes, Pneumonectomy, Minimally Invasive Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thoracic drainage managementProcedure or surgery
After uniportal VATS pulmonary lobectomy, the traditional silicone tube which placed through the surgical incision was removed in the operating room in the experimental group.
| Study group | Role | What they receive |
|---|---|---|
| Puncture tube group | Experimental | After the operation, the traditional traditional silicone tube which placed through the surgical incision was removed in the operating room, and the small puncture tube was retained for thoracic drainage. Receives: Procedure: thoracic drainage management |
| Traditional tubes group | No intervention | Routine thoracic drainage management measures were adopted, that is, both of the small puncture tube and traditional silicone tube were retained after surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative complications
The incidence of complications within 30 days after surgery in each arm
Measured: within 30 days after surgery
Secondary outcomes (2)
Incidence of subcutaneous emphysema after operation
The incidence of subcutaneous emphysema after operation in each arm
Measured: within 30 days after surgery
Incidence of postoperative pneumothorax
The incidence of postoperative pneumothorax in each arm
Measured: within 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start25 Jan 2021
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest TubesStudies of the same condition, open and under way.
- More trials run by Fujian Medical University Union HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chun Chen, MD, Study director, Fujian Medical University Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04718272
- Sponsor's protocol ID
- CDTM UNION
- Status last verified
- May 2021
- First submitted
- 18 Jan 2021
- Last updated
- 11 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of the Application of Thoracic Puncture Tube VS Combination of Puncture Tube and Silicone Tube After Uniportal VATS Pulmonary Lobectomy
- ClinicalTrials.gov ID
- NCT04718272
- Acronym / sponsor ID
- CDTM UNION
- Conditions
- Chest Tubes, Pneumonectomy, Minimally Invasive Surgery
- Keywords
- Chest Tubes, Pneumonectomy, Minimally Invasive Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There have been several reports on the feasibility of a no-drain policy after pneumonectomy, but the policy is not widely accepted because silent massive hemorrhage, delayed air leaks, and chylothorax would always be major worries for thoracic surgeons, and all of the researches were retrospective case studies with small sample size and insufficient evidence. Therefore, the purpose of this study is to to evaluate safety and feasibility of an improved policy, the application of a small thoracic puncture tube after pulmonary lobectomy.
Detailed description
This study will be accepted in patients with uniportal VATS(Video-assisted Thoracoscopic Surgery）lobetomy. A randomized controlled study protocol will be used, and The patients will be devided into two groups: experimental group for the application of a small thoracic puncture tube and control group for the application of Combination of the puncture tube and traditional silicone tube. The intraoperative conditions, postoperative recovery and the incidence of perioperative complications will be compared. The safety and feasibility of the application of the small thoracic puncture tube after pulmonary lobectomy will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Puncture tube group | Experimental | Procedure: thoracic drainage managementAfter the operation, the traditional traditional silicone tube which placed through the surgical incision was removed in the operating room, and the small puncture tube was retained for thoracic drainage. |
| Traditional tubes group | No intervention | –Routine thoracic drainage management measures were adopted, that is, both of the small puncture tube and traditional silicone tube were retained after surgery. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age and gender: 18-70 years old, male and female unlimited;
- Cardiopulmonary function can tolerate operation;
- Primary non-small cell lung cancer was diagnosed by preoperative or intraoperative pathology. The surgical ranges are uni-portal VATS lobectomy with or without mediastinal lymph node dissection or sampling. In cases with multiple nodules in other lobes of the same side, small wedge resections are allowed;
- No air leakage was observed intraoperatively. Meanwhile, after operation, there are also no air leakage observed in water seal bottle when patients are changed from lateral decubitus to horizontal position.
- Patients and their family members can understand and are willing to participate in this clinical study and sign the informed consent..
Key exclusion criteria (6 listed)
- Patients with a severe emphysema or pulmonary bullae;
- Patients with a history of chemotherapy or chemo-radiotherapy;
- Patients with a history of chest surgery;
- Extensive thoracic adhesion ;
- A history of serious mental illness;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| thoracic drainage managementAfter uniportal VATS pulmonary lobectomy, the traditional silicone tube which placed through the surgical incision was removed in the operating room in the experimental group. | Procedure or surgery | Puncture tube group |
Primary outcome
Incidence of postoperative complications
Time frame: within 30 days after surgery
The incidence of complications within 30 days after surgery in each arm
2 secondary outcomes
Incidence of subcutaneous emphysema after operation
Time frame: within 30 days after surgery
Incidence of postoperative pneumothorax
Time frame: within 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
Related trials for Chest Tubes
Not yet recruiting
Effect of Warm Footbath Combined With Relaxation Exercise on Pain and Anxiety During Chest Tube Removal After Cardiac Surgery
Chest Tube Removal
RecruitingPhase 1/2
Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)
High Grade Epithelial Ovarian Cancer, High Grade Serous Ovarian Cancer
Recruiting
Effect of Box Breathing Before Chest Tube Removal After Open-Heart Surgery
Open-Heart Surgery
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Recruiting
Hyperangulated vs Standard Videolaryngoscopy vs Direct Laryngoscopy for Double-Lumen Endobronchial Tube Intubation
Endobronchial Intubation, Double Lumen Tube Intubation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chun Chen, MD study director
Fujian Medical University Union Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing thoracic drainage management in people with Chest Tubes and Pneumonectomy, run by Fujian Medical University Union Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guobing Xu, MD (15880005394, 15880005394@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative complications (time frame: within 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2021.