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Quality of Life in Patients With Traumatic Rib Fracture After Rib Fracture Surgery

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ClinicalTrials.gov Identifier: NCT03487458
Recruitment Status : Unknown
Verified June 2017 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : April 4, 2018
Last Update Posted : April 4, 2018
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Tracking Information
First Submitted Date  ICMJE November 5, 2017
First Posted Date  ICMJE April 4, 2018
Last Update Posted Date April 4, 2018
Actual Study Start Date  ICMJE June 13, 2017
Estimated Primary Completion Date June 12, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2018)
Short Form-36 (SF-36) [ Time Frame: Assessment of change in SF-36 scores for the control group at admission and after discharge for up to six months and for the surgical group before and after surgery for up to 6 months. ]
questionnaire filled by patient
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2018)
  • Work Quality Index (WQI) [ Time Frame: Assessment of change in WQI for the control group at admission and after discharge for up to six months and for the surgical group before and after surgery through study completion for up to 6 months. ]
    questionnaire filled by patient
  • Days of admission [ Time Frame: Assessment of total number of days of hospitalization including ICU stay after admission through study completion for up to 6 months. ]
    Days of admission in the hospital
  • Severity of hemothorax [ Time Frame: Assessment of progression or resolution of hemothorax after simple chest drainage for up to 3 days after chest drainage insertion in the control group and before operation, post-OP day 1, and post-OP day 3 for up to 3 days' post-operation in the surgical ]
    The severity of hemothorax is evaluated by amount of chest tube drainage measured in milliliters per day.
  • Pain [ Time Frame: Every 8 hours during hospitalization for up to 1 month and outpatient follow-up at 1 month, 3 months and 6 months after discharge through study completion for a total of 6 months. ]
    The Numeric Rating Scale (NRS-11), with a scale from 0 to 10, with 0 as no pain, 10 as extremely painful
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Quality of Life in Patients With Traumatic Rib Fracture After Rib Fracture Surgery
Official Title  ICMJE Quality of Life in Patients With Traumatic Rib Fracture After Rib Fracture Surgery: A Prospective Cohort Study
Brief Summary This study is a prospective study. Patients with traumatic rib fractures are divided into control group and surgical (OP) group, depending on whether they undergo rib fracture fixation surgeries. They complete Short Form-36 and Work Quality Index (WQI) before surgery and after surgery (before discharge, post-surgery 1 month, 3 months and 6 months). The goal of this study is to examine the life quality of patients who receive surgical treatment for rib fracture by analyzing patients' response, comorbidity, vital signs (blood pressure, heart rate, respiratory rate, Glasgow Coma Scale (GCS) etc.), severity of fracture (AIS, ISS) and medical costs. The investigators hope to find the most suitable method of treatment for patients with rib fractures.
Detailed Description

Traumatic rib fracture is one of the most common thoracic traumas. Patients often complain of severe pain of the fracture site, especially when coughing, sneezing, inhaling and lifting arms. If there is obvious displacement of the rib fracture, there are risks of life-threatening open pneumothorax, hemothorax and internal bleeding. Multiple rib fractures may even cause flail chest, leading to respiratory distress and respiratory failure.

Even patients with mild rib fractures may suffer from pain, causing movement limitations and poor sleep. Those whose occupations require heavy labors may even lose their jobs.

Large wounds and difficulties with localization and fixation made surgical interventions a poor option in the past. Thus, treatment goals were set on pain control and infection prevention. However, in recent years, there are improvements with medical imaging, endoscopy and fracture fixation instruments, so rib fracture fixations become a new treatment option. In addition, patients now ask for higher life quality after the trauma recovery, and not just passively controlling the pain and infection.

Therefore, this study is a prospective study. The investigators enrolled patients with traumatic rib fractures from the National Taiwan University Hospital and Far Eastern Memorial Hospital from July 2017 to July 2018. This study incorporated the use of Short Form-36 and Work Quality Index (WQI) to compare the control groups and the surgical (OP) groups. The participants would complete the questionnaires before surgery and after surgery (before discharge, post-surgery 1 month, 3 months and 6 months).

The goal of this study is to examine the life quality of patients who receive surgical treatment for rib fracture by analyzing patients' response, comorbidity, vital signs (blood pressure, heart rate, respiratory rate, GCS etc.), severity of fracture (AIS, ISS) and medical costs. The investigators hope to find the most suitable method of treatment for patients with rib fractures.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rib Fractures
Intervention  ICMJE Procedure: Rib Fixation Surgery
Rib Fixation Surgery
Study Arms  ICMJE
  • No Intervention: Control
    participants receive no surgical treatment
  • Experimental: Rib Fixation Surgery
    participants receive surgical treatment
    Intervention: Procedure: Rib Fixation Surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 3, 2018)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 12, 2018
Estimated Primary Completion Date June 12, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Absolute Indications:

  1. Flail chest with paradoxical respiration
  2. Multiple rib fractures with uncontrolled hemothorax or pneumothorax
  3. Severe thoracic trauma causing respiratory failure (ex poor blood oxygen saturation, hypercapnia, overtime intubation etc.)

Relative Indications:

  1. Fractures of 3 or more ribs, with moderate amount of hemothorax or pneumothorax
  2. Fractures of 3 or more ribs, with clavicle or scapula fractures, requiring surgical intervention
  3. Fractures of 3 or more ribs, with obvious rib displacement and pain
  4. Chronic neuropathic pain, with poor drug control
  5. Symptoms due to poor healing of fracture site (ex. dyspnea or restrictive lung disease)
  6. Chest deformity or other cosmetic factors
  7. Other personal factors (ex. disability caused by rib fractures)

Exclusion Criteria:

  1. High risk for surgery (ex. Age greater than 75 y/o, poor cardiopulmonary function, abnormal coagulation, end-stage renal disease, hepatic failure etc.)
  2. Severe chest trauma, with large area of lung contusion or pulmonary embolism
  3. More than 2 organs of systemic severe trauma (ex. combining head trauma, abdominal internal bleeding, abdominal organ rupture etc.)
  4. Poor rib fracture site (ex. posterior axillary line, 1st-3rd rib, sub-scapula etc.)
  5. Patient refuses surgery
  6. current acute infection
  7. Allergy to surgical instruments
  8. Lack of sufficient blood supply, poor bone density or potential infection
  9. Psychiatric or neuropathic conditions causing inability to obey doctor's order
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03487458
Other Study ID Numbers  ICMJE 201703114RIND
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Taiwan University Hospital
Study Sponsor  ICMJE National Taiwan University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account National Taiwan University Hospital
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP