Chest TraumaNCT04541758
Comparing the Efficacy of Conservative Treatment With Minimally Invasive Surgery in the Treatment of Rib Fractures
A study testing surgical treatment and Conservative treatment in people with Chest Trauma and Rib Fractures, run by Shanghai 6th People's Hospital.
Trial summary
Open, randomized, parallel controlled prospective clinical study design was used in this study.Subjects were patients with 2-4 displaced non-flail rib fractures.Operation group (Group 1) : minimally invasive internal fixation operation group under spontaneous breathing anesthesia.In the operation group of minimally… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chest Trauma, Rib Fractures, Surgery--Complications
- What is being tested?
- surgical treatment and Conservative treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2021to 30 Jun 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
- Unilateral thoracic trauma, fractured ends of rib fractures displaced 2-4 places
- Displaced fracture（CT image shows double displacement of bone cortex） located in the 3rd to 10th rib
- The number of broken ends of displaced fractures is greater than that of undisplaced fractures
- The length of time from injury to hospitalization <24 hours
- Age range（18-70）
- ASA grade I-II
- BMI < 30
- Preoperative partial arterial oxygen pressure >60mmHg, partial arterial carbon dioxide pressure <50mmHg
Who cannot join
- Difficult airway
- History of esophageal reflux
- Myasthenia gravis
- Abnormal coagulation system
- History of gastrointestinal ulcer or bleeding
- History of anaesthesia related drug allergy
Show all 15Show fewer
- A history of asthma or chronic obstructive emphysema
- 8. Women during pregnancy
- 9. Flail chest
- 10. Combined with severe craniocerebral trauma and external abdominal injuries
- 11. Recent use of clopidogrel, warfarin and aspirin seriously affects blood clotting
- 12. Self-administered analgesics after injury
- 13.Massive hemopneumothorax requires emergency surgery
- 14. Patients who cannot tolerate surgery
- -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparing the Efficacy of Conservative Treatment With Minimally Invasive Surgery in the Treatment of 2-4 Displaced Rib Fractures:A Prospective Randomized Controlled Study
Open, randomized, parallel controlled prospective clinical study design was used in this study.Subjects were patients with 2-4 displaced non-flail rib fractures.Operation group (Group 1) : minimally invasive internal fixation operation group under spontaneous breathing anesthesia.In the operation group of minimally invasive internal fixation under autonomic respiratory anesthesia, the fracture was determined preoperatively by chest CT+ three-dimensional reconstruction of the ribs, and the optimal incision location was determined. The fracture was exposed through as many small incisions as possible, and fixed with titanium plate or clon-type plate. During the operation, the autonomic respiratory anesthesia and paraviral nerve block technology was adopted.In the conservative group (group 2), routine treatment measures such as analgesia and chest strap fixed were adopted.The purpose of this study was to evaluate the safety, feasibility, and efficacy of minimally invasive and conservative treatment for rib fractures with different Numbers of displaced ends.
Read the detailed description
An open, randomized, parallel controlled prospective clinical study design type was used in this study. Subjects were patients with two to four displaced non-flail chest fractures of the ribs. Operation group (Group 1) : minimally invasive internal fixation operation group under spontaneous breathing anesthesia. In the operation group of minimally invasive internal fixation under autonomic respiratory anesthesia, the fracture was determined preoperatively by chest CT+ three-dimensional reconstruction of the ribs, and the optimal incision location was determined. The fracture was exposed through as many small incisions as possible, and fixed with titanium plate or clon-type plate. During the operation, the autonomic respiratory anesthesia and paraviral nerve block technology was adopted. In the conservative group (group 2), routine treatment measures such as analgesia, hemostasis and chest band fixation were adopted. The effects of the two treatments on lung function, pain index, complications and QoL were evaluated. It provides theoretical basis for the treatment of rib fracture
- Conditions
- Chest Trauma, Rib Fractures, Surgery--Complications
- Being tested
- surgical treatment, Conservative treatment
- Keywords
- rib fractrue;surgical treatment;Rapid recovery
- Medical subject headings
- Thoracic Injuries, Rib Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical treatmentProcedure or surgery
surgical treatment and Conservative treatment
Conservative treatmentProcedure or surgery
Conservative treatment
| Study group | Role | What they receive |
|---|---|---|
| surgical treatment | Experimental | Minimally invasive internal fixation under spontaneous respiratory anesthesia and analgesic treatment and chest strap fixation Receives: Procedure: surgical treatment; Procedure: Conservative treatment |
| Conservative treatment | Experimental | analgesic treatment and chest strap fixation Receives: Procedure: Conservative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage improvement of lung function FEV1(Forced expiratory volume in one second)
FEV1(Forced expiratory volume in one second)，FEV1% ：percentage of the expected value
Measured: FEV1%(One week after treatment)-FEV1%(Admitted)
Secondary outcomes (11)
Percentage improvement of lung function FVC
FVC（forced vital capacity），FVC%：percentage of the expected value
Measured: FVC%(One week after treatment)-FVC%(Admitted)
Percentage improvement of lung function PEF
PEF（peak expiratory flow ），PEF%：percentage of the expected value
Measured: PEF%(One week after treatment)-PEF%(Admitted)
Pain index
visual analogue scale，VAS（0-10）0：no pain；10：severe pain
Measured: Admitted；One week after treatment；One month after treatment;Three month after treatment;Half a year;One year
Pleural effusion
Measured by chest CT
Measured: Admitted；One week after treatment；One month after treatment;Three month after treatment;Half a year;One year
Mortality rate
Deaths associated with this study
Measured: Admitted；One week after treatment；One month after treatment;Three month after treatment;Half a year;One year
Length of hospital stay
Length of hospital stay
Measured: Admitted；One week after treatment；One month after treatment;Three month after treatment;Half a year;One year
Cost of treatment
Sum of all treatment costs
Measured: One year
Chronic pain
Pain lasting more than three months（It is suggested in the related article that pain lasting more than 3 months is chronic pain）visual analogue scale，VAS（0-10）0：no pain；10：severe pain
Measured: Three month after treatment;Half a year;One year
Quality of Life score
The Barthel index of ADL
Measured: One week after treatment；One month after treatment;Three month after treatment;Half a year;One year
Time to resume routine work
Time to resume routine work
Measured: One week after treatment；One month after treatment;Three month after treatment;Half a year;One year
Duration of analgesic medication
Duration of analgesic medication
Measured: intraoperative；One week after treatment；One month after treatment;Three month after treatment;Half a year;One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start1 Mar 2021 (estimated)
- Primary completion10 Jun 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest TraumaStudies of the same condition, open and under way.
- 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
- 238 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 6th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Yang, Shanghai 6th People's Hospital
- Investigators
- Yi Yang, PHD, Study director, Shanghai 6th People's HospitalZongli Gao, PHD, Study chair, Shanghai 6th People's HospitalYonghong Zhao, PHD, Study chair, Shanghai 6th People's HospitalWeiming Wu, PHD, Study chair, Shanghai 6th People's HospitalWeigang Zhao, PHD, Study chair, Shanghai 6th People's HospitalTiancheng Zhao, PHD, Study chair, Shanghai 6th People's HospitalXiang Guo, PHD, Study chair, Shanghai 6th People's HospitalLei Wang, PHD, Study chair, Shanghai 6th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04541758
- Sponsor's protocol ID
- ynlc201908
- Status last verified
- Jan 2021
- First submitted
- 15 Aug 2020
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will not be Shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Efficacy of Conservative Treatment With Minimally Invasive Surgery in the Treatment of 2-4 Displaced Rib Fractures:A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04541758
- Acronym / sponsor ID
- ynlc201908
- Conditions
- Chest Trauma, Rib Fractures, Surgery--Complications
- Keywords
- rib fractrue;surgical treatment;Rapid recovery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 238 participants (estimated)
- Lead sponsor
- Shanghai 6th People's HospitalUniversity, hospital or other
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 10 Jun 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 9 Sep 2020 (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.
Open, randomized, parallel controlled prospective clinical study design was used in this study.Subjects were patients with 2-4 displaced non-flail rib fractures.Operation group (Group 1) : minimally invasive internal fixation operation group under spontaneous breathing anesthesia.In the operation group of minimally invasive internal fixation under autonomic respiratory anesthesia, the fracture was determined preoperatively by chest CT+ three-dimensional reconstruction of the ribs, and the optimal incision location was determined. The fracture was exposed through as many small incisions as possible, and fixed with titanium plate or clon-type plate. During the operation, the autonomic respiratory anesthesia and paraviral nerve block technology was adopted.In the conservative group (group 2), routine treatment measures such as analgesia and chest strap fixed were adopted.The purpose of this study was to evaluate the safety, feasibility, and efficacy of minimally invasive and conservative treatment for rib fractures with different Numbers of displaced ends.
Detailed description
An open, randomized, parallel controlled prospective clinical study design type was used in this study. Subjects were patients with two to four displaced non-flail chest fractures of the ribs. Operation group (Group 1) : minimally invasive internal fixation operation group under spontaneous breathing anesthesia. In the operation group of minimally invasive internal fixation under autonomic respiratory anesthesia, the fracture was determined preoperatively by chest CT+ three-dimensional reconstruction of the ribs, and the optimal incision location was determined. The fracture was exposed through as many small incisions as possible, and fixed with titanium plate or clon-type plate. During the operation, the autonomic respiratory anesthesia and paraviral nerve block technology was adopted. In the conservative group (group 2), routine treatment measures such as analgesia, hemostasis and chest band fixation were adopted. The effects of the two treatments on lung function, pain index, complications and QoL were evaluated. It provides theoretical basis for the treatment of rib fracture
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| surgical treatment | Experimental | Procedure: surgical treatment, Procedure: Conservative treatmentMinimally invasive internal fixation under spontaneous respiratory anesthesia and analgesic treatment and chest strap fixation |
| Conservative treatment | Experimental | Procedure: Conservative treatmentanalgesic treatment and chest strap fixation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Unilateral thoracic trauma, fractured ends of rib fractures displaced 2-4 places
- Displaced fracture（CT image shows double displacement of bone cortex） located in the 3rd to 10th rib
- The number of broken ends of displaced fractures is greater than that of undisplaced fractures
- The length of time from injury to hospitalization <24 hours
- Age range（18-70）
Key exclusion criteria (15 listed)
- Difficult airway
- History of esophageal reflux
- Myasthenia gravis
- Abnormal coagulation system
- History of gastrointestinal ulcer or bleeding
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 |
|---|---|---|
| surgical treatmentsurgical treatment and Conservative treatment | Procedure or surgery | surgical treatment |
| Conservative treatmentConservative treatment | Procedure or surgery | Conservative treatment, surgical treatment |
Primary outcome
Percentage improvement of lung function FEV1(Forced expiratory volume in one second)
Time frame: FEV1%(One week after treatment)-FEV1%(Admitted)
FEV1(Forced expiratory volume in one second)，FEV1% ：percentage of the expected value
11 secondary outcomes
Percentage improvement of lung function FVC
Time frame: FVC%(One week after treatment)-FVC%(Admitted)
Percentage improvement of lung function PEF
Time frame: PEF%(One week after treatment)-PEF%(Admitted)
Pain index
Time frame: Admitted；One week after treatment；One month after treatment;Three month after treatment;Half a year;One year
Pleural effusion
Time frame: Admitted；One week after treatment；One month after treatment;Three month after treatment;Half a year;One year
Mortality rate
Time frame: Admitted；One week after treatment；One month after treatment;Three month after treatment;Half a year;One year
Length of hospital stay
Time frame: Admitted；One week after treatment；One month after treatment;Three month after treatment;Half a year;One year
Cost of treatment
Time frame: One year
Chronic pain
Time frame: Three month after treatment;Half a year;One year
Quality of Life score
Time frame: One week after treatment；One month after treatment;Three month after treatment;Half a year;One year
Time to resume routine work
Time frame: One week after treatment；One month after treatment;Three month after treatment;Half a year;One year
Duration of analgesic medication
Time frame: intraoperative；One week after treatment；One month after treatment;Three month after treatment;Half a year;One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- Individual participant dataSharing planned: No. The data will not be Shared with other researchers
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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.
Yi Yang, PHD study director
Shanghai 6th People's Hospital
Zongli Gao, PHD study chair
Shanghai 6th People's Hospital
Yonghong Zhao, PHD study chair
Shanghai 6th People's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing surgical treatment and Conservative treatment in people with Chest Trauma and Rib Fractures, run by Shanghai 6th People's Hospital.
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 8 inclusion and 15 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 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Yang Li, PHD (13122109923, drliyang1991@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage improvement of lung function FEV1(Forced expiratory volume in one second) (time frame: FEV1%(One week after treatment)-FEV1%(Admitted)). 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 20 Jan 2021.