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

Rib Fractures Clinical Trial

Official title:

Quality of Life in Patients With Traumatic Rib Fracture After Rib Fracture Surgery: A Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03487458
• Other study ID #: 201703114RIND
• Status: Recruiting
• Phase: N/A
• First received: November 5, 2017
• Last updated: April 3, 2018
• Start date: June 13, 2017
• Est. completion date: June 12, 2018

Study information

• Verified date: June 2017
• Source: National Taiwan University Hospital
• Contact: Hsien-Chi Liao
• Phone: 886-2-23123456
• Email: polarisliao[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 12, 2018
• Est. primary completion date: June 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Rib Fractures

Intervention

Procedure:
• Rib Fixation Surgery
Rib Fixation Surgery

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short Form-36 (SF-36)	questionnaire filled by patient	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.
Secondary	Work Quality Index (WQI)	questionnaire filled by patient	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.
Secondary	Days of admission	Days of admission in the hospital	Assessment of total number of days of hospitalization including ICU stay after admission through study completion for up to 6 months.
Secondary	Severity of hemothorax	The severity of hemothorax is evaluated by amount of chest tube drainage measured in milliliters per day.	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
Secondary	Pain	The Numeric Rating Scale (NRS-11), with a scale from 0 to 10, with 0 as no pain, 10 as extremely painful	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.