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

Primary Purpose

Rib Fractures

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Rib Fixation Surgery
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rib Fractures

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Rib Fixation Surgery

Arm Description

participants receive no surgical treatment

participants receive surgical treatment

Outcomes

Primary Outcome Measures

Short Form-36 (SF-36)
questionnaire filled by patient

Secondary Outcome Measures

Work Quality Index (WQI)
questionnaire filled by patient
Days of admission
Days of admission in the hospital
Severity of hemothorax
The severity of hemothorax is evaluated by amount of chest tube drainage measured in milliliters per day.
Pain
The Numeric Rating Scale (NRS-11), with a scale from 0 to 10, with 0 as no pain, 10 as extremely painful

Full Information

First Posted
November 5, 2017
Last Updated
April 3, 2018
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03487458
Brief Title
Quality of Life in Patients With Traumatic Rib Fracture After Rib Fracture Surgery
Official Title
Quality of Life in Patients With Traumatic Rib Fracture After Rib Fracture Surgery: A Prospective Cohort Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 13, 2017 (Actual)
Primary Completion Date
June 12, 2018 (Anticipated)
Study Completion Date
June 12, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rib Fractures

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
participants receive no surgical treatment
Arm Title
Rib Fixation Surgery
Arm Type
Experimental
Arm Description
participants receive surgical treatment
Intervention Type
Procedure
Intervention Name(s)
Rib Fixation Surgery
Intervention Description
Rib Fixation Surgery
Primary Outcome Measure Information:
Title
Short Form-36 (SF-36)
Description
questionnaire filled by patient
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.
Secondary Outcome Measure Information:
Title
Work Quality Index (WQI)
Description
questionnaire filled by patient
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.
Title
Days of admission
Description
Days of admission in the hospital
Time Frame
Assessment of total number of days of hospitalization including ICU stay after admission through study completion for up to 6 months.
Title
Severity of hemothorax
Description
The severity of hemothorax is evaluated by amount of chest tube drainage measured in milliliters per day.
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
Title
Pain
Description
The Numeric Rating Scale (NRS-11), with a scale from 0 to 10, with 0 as no pain, 10 as extremely painful
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Absolute Indications: Flail chest with paradoxical respiration Multiple rib fractures with uncontrolled hemothorax or pneumothorax Severe thoracic trauma causing respiratory failure (ex poor blood oxygen saturation, hypercapnia, overtime intubation etc.) Relative Indications: Fractures of 3 or more ribs, with moderate amount of hemothorax or pneumothorax Fractures of 3 or more ribs, with clavicle or scapula fractures, requiring surgical intervention Fractures of 3 or more ribs, with obvious rib displacement and pain Chronic neuropathic pain, with poor drug control Symptoms due to poor healing of fracture site (ex. dyspnea or restrictive lung disease) Chest deformity or other cosmetic factors Other personal factors (ex. disability caused by rib fractures) Exclusion Criteria: High risk for surgery (ex. Age greater than 75 y/o, poor cardiopulmonary function, abnormal coagulation, end-stage renal disease, hepatic failure etc.) Severe chest trauma, with large area of lung contusion or pulmonary embolism More than 2 organs of systemic severe trauma (ex. combining head trauma, abdominal internal bleeding, abdominal organ rupture etc.) Poor rib fracture site (ex. posterior axillary line, 1st-3rd rib, sub-scapula etc.) Patient refuses surgery current acute infection Allergy to surgical instruments Lack of sufficient blood supply, poor bone density or potential infection Psychiatric or neuropathic conditions causing inability to obey doctor's order
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hsien-Chi Liao
Phone
886-2-23123456
Ext
51611
Email
polarisliao@hotmail.com
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10048
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hsien-Chi Liao
Phone
886-2-23123456
Ext
51611
Email
polarisliao@hotmail.com

12. IPD Sharing Statement

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

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