Comparing the Efficacy of Conservative Treatment With Minimally Invasive Surgery in the Treatment of Rib Fractures
1 other identifier
interventional
238
0 countries
N/A
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2021
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 15, 2020
CompletedFirst Posted
Study publicly available on registry
September 9, 2020
CompletedStudy Start
First participant enrolled
March 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 10, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedJanuary 20, 2021
January 1, 2021
2.3 years
August 15, 2020
January 17, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
FEV1%(One week after treatment)-FEV1%(Admitted)
Secondary Outcomes (11)
Percentage improvement of lung function FVC
FVC%(One week after treatment)-FVC%(Admitted)
Percentage improvement of lung function PEF
PEF%(One week after treatment)-PEF%(Admitted)
Pain index
Admitted；One week after treatment；One month after treatment;Three month after treatment;Half a year;One year
Pleural effusion
Admitted；One week after treatment；One month after treatment;Three month after treatment;Half a year;One year
Mortality rate
Admitted；One week after treatment；One month after treatment;Three month after treatment;Half a year;One year
- +6 more secondary outcomes
Study Arms (2)
surgical treatment
EXPERIMENTALMinimally invasive internal fixation under spontaneous respiratory anesthesia and analgesic treatment and chest strap fixation
Conservative treatment
EXPERIMENTALanalgesic treatment and chest strap fixation
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Difficult airway
- History of esophageal reflux
- Myasthenia gravis
- Abnormal coagulation system
- History of gastrointestinal ulcer or bleeding
- History of anaesthesia related drug allergy
- A history of asthma or chronic obstructive emphysema
- \. Women during pregnancy
- \. Flail chest
- \. Combined with severe craniocerebral trauma and external abdominal injuries
- \. Recent use of clopidogrel, warfarin and aspirin seriously affects blood clotting
- \. Self-administered analgesics after injury
- Massive hemopneumothorax requires emergency surgery
- \. Patients who cannot tolerate surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Yi Yang, PHD
Shanghai 6th People's Hospital
- STUDY CHAIR
Zongli Gao, PHD
Shanghai 6th People's Hospital
- STUDY CHAIR
Yonghong Zhao, PHD
Shanghai 6th People's Hospital
- STUDY CHAIR
Weiming Wu, PHD
Shanghai 6th People's Hospital
- STUDY CHAIR
Weigang Zhao, PHD
Shanghai 6th People's Hospital
- STUDY CHAIR
Tiancheng Zhao, PHD
Shanghai 6th People's Hospital
- STUDY CHAIR
Xiang Guo, PHD
Shanghai 6th People's Hospital
- STUDY CHAIR
Lei Wang, PHD
Shanghai 6th People's Hospital
- STUDY CHAIR
Weiwei He, PHD
Shanghai 6th People's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 15, 2020
First Posted
September 9, 2020
Study Start
March 1, 2021
Primary Completion
June 10, 2023
Study Completion
June 30, 2024
Last Updated
January 20, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share
The data will not be Shared with other researchers