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Comparing the Efficacy of Conservative Treatment With Minimally Invasive Surgery in the Treatment of Rib Fractures

Primary Purpose

Chest Trauma, Rib Fractures, Surgery--Complications

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
surgical treatment
Conservative treatment
Sponsored by
Shanghai 6th People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chest Trauma focused on measuring rib fractrue;surgical treatment;Rapid recovery

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Unilateral thoracic trauma, fractured ends of rib fractures displaced 2-4 places
  2. Displaced fracture（CT image shows double displacement of bone cortex） located in the 3rd to 10th rib
  3. The number of broken ends of displaced fractures is greater than that of undisplaced fractures
  4. The length of time from injury to hospitalization <24 hours
  5. Age range（18-70）
  6. ASA grade I-II
  7. BMI < 30
  8. Preoperative partial arterial oxygen pressure >60mmHg, partial arterial carbon dioxide pressure <50mmHg

Exclusion Criteria:

  1. Difficult airway
  2. History of esophageal reflux
  3. Myasthenia gravis
  4. Abnormal coagulation system
  5. History of gastrointestinal ulcer or bleeding
  6. History of anaesthesia related drug allergy

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

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    surgical treatment

    Conservative treatment

    Arm Description

    Minimally invasive internal fixation under spontaneous respiratory anesthesia and analgesic treatment and chest strap fixation

    analgesic treatment and chest strap fixation

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Percentage improvement of lung function FVC
    FVC（forced vital capacity），FVC%：percentage of the expected value
    Percentage improvement of lung function PEF
    PEF（peak expiratory flow ），PEF%：percentage of the expected value
    Pain index
    visual analogue scale，VAS（0-10）0：no pain；10：severe pain
    Pleural effusion
    Measured by chest CT
    Mortality rate
    Deaths associated with this study
    Length of hospital stay
    Length of hospital stay
    Cost of treatment
    Sum of all treatment costs
    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
    Quality of Life score
    The Barthel index of ADL
    Time to resume routine work
    Time to resume routine work
    Duration of analgesic medication
    Duration of analgesic medication

    Full Information

    First Posted
    August 15, 2020
    Last Updated
    January 17, 2021
    Sponsor
    Shanghai 6th People's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04541758
    Brief Title
    Comparing the Efficacy of Conservative Treatment With Minimally Invasive Surgery in the Treatment of Rib Fractures
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 1, 2021 (Anticipated)
    Primary Completion Date
    June 10, 2023 (Anticipated)
    Study Completion Date
    June 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shanghai 6th People's Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chest Trauma, Rib Fractures, Surgery--Complications
    Keywords
    rib fractrue;surgical treatment;Rapid recovery

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    238 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    surgical treatment
    Arm Type
    Experimental
    Arm Description
    Minimally invasive internal fixation under spontaneous respiratory anesthesia and analgesic treatment and chest strap fixation
    Arm Title
    Conservative treatment
    Arm Type
    Experimental
    Arm Description
    analgesic treatment and chest strap fixation
    Intervention Type
    Procedure
    Intervention Name(s)
    surgical treatment
    Intervention Description
    surgical treatment and Conservative treatment
    Intervention Type
    Procedure
    Intervention Name(s)
    Conservative treatment
    Intervention Description
    Conservative treatment
    Primary Outcome Measure Information:
    Title
    Percentage improvement of lung function FEV1(Forced expiratory volume in one second)
    Description
    FEV1(Forced expiratory volume in one second)，FEV1% ：percentage of the expected value
    Time Frame
    FEV1%(One week after treatment)-FEV1%(Admitted)
    Secondary Outcome Measure Information:
    Title
    Percentage improvement of lung function FVC
    Description
    FVC（forced vital capacity），FVC%：percentage of the expected value
    Time Frame
    FVC%(One week after treatment)-FVC%(Admitted)
    Title
    Percentage improvement of lung function PEF
    Description
    PEF（peak expiratory flow ），PEF%：percentage of the expected value
    Time Frame
    PEF%(One week after treatment)-PEF%(Admitted)
    Title
    Pain index
    Description
    visual analogue scale，VAS（0-10）0：no pain；10：severe pain
    Time Frame
    Admitted；One week after treatment；One month after treatment;Three month after treatment;Half a year;One year
    Title
    Pleural effusion
    Description
    Measured by chest CT
    Time Frame
    Admitted；One week after treatment；One month after treatment;Three month after treatment;Half a year;One year
    Title
    Mortality rate
    Description
    Deaths associated with this study
    Time Frame
    Admitted；One week after treatment；One month after treatment;Three month after treatment;Half a year;One year
    Title
    Length of hospital stay
    Description
    Length of hospital stay
    Time Frame
    Admitted；One week after treatment；One month after treatment;Three month after treatment;Half a year;One year
    Title
    Cost of treatment
    Description
    Sum of all treatment costs
    Time Frame
    One year
    Title
    Chronic pain
    Description
    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
    Time Frame
    Three month after treatment;Half a year;One year
    Title
    Quality of Life score
    Description
    The Barthel index of ADL
    Time Frame
    One week after treatment；One month after treatment;Three month after treatment;Half a year;One year
    Title
    Time to resume routine work
    Description
    Time to resume routine work
    Time Frame
    One week after treatment；One month after treatment;Three month after treatment;Half a year;One year
    Title
    Duration of analgesic medication
    Description
    Duration of analgesic medication
    Time Frame
    intraoperative；One week after treatment；One month after treatment;Three month after treatment;Half a year;One year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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 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 -
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yang Li, PHD
    Phone
    13122109923
    Email
    drliyang1991@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yi Yang, PHD
    Organizational Affiliation
    Shanghai 6th People's Hospital
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Zongli Gao, PHD
    Organizational Affiliation
    Shanghai 6th People's Hospital
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Yonghong Zhao, PHD
    Organizational Affiliation
    Shanghai 6th People's Hospital
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Weiming Wu, PHD
    Organizational Affiliation
    Shanghai 6th People's Hospital
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Weigang Zhao, PHD
    Organizational Affiliation
    Shanghai 6th People's Hospital
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Tiancheng Zhao, PHD
    Organizational Affiliation
    Shanghai 6th People's Hospital
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Xiang Guo, PHD
    Organizational Affiliation
    Shanghai 6th People's Hospital
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Lei Wang, PHD
    Organizational Affiliation
    Shanghai 6th People's Hospital
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Weiwei He, PHD
    Organizational Affiliation
    Shanghai 6th People's Hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    The data will not be Shared with other researchers

    Learn more about this trial

    Comparing the Efficacy of Conservative Treatment With Minimally Invasive Surgery in the Treatment of Rib Fractures

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