Back to resultsProspective Study of Video-assisted Rib Planting in Chest Wall Stabilization
Primary Purpose
Rib Fractures, Rib Fracture Multiple
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
video-assisted rib planting
Sponsored by
About this trial
This is an interventional treatment trial for Rib Fractures focused on measuring internal fixation, video-assisted, chest wall stabilization, prospective study
Eligibility Criteria
Inclusion Criteria:
-≥3 unilateral rib displacement fractures
- 18-70 years old
- ASA score I-II
- Preoperative arterial oxygen partial pressure >60mmHg
- Carbon dioxide partial pressure <50mmHg
Exclusion Criteria:
- The distance from the broken end of the posterior rib fracture to the spine is less than 2cm
- Airway stenosis
- Abnormal coagulation system
- History of peptic ulcer or bleeding
- History of allergy to anesthesia related drugs
- History of asthma or chronic obstructive pulmonary emphysema
- Pregnant women
Sites / Locations
- Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
video-assisted rib planting
Arm Description
Outcomes
Primary Outcome Measures
The pain score after operation
The investigators evaluate and record the patients' pain score after operation by visual analog scale (VAS)，which is used to evaluate pain scores 6h,12h,and 24h after the operation.
0-10 is used to represent different degrees of pain, 0 is painless and 10 is severe pain. The grading criteria of pain were: 0: no pain; 1-3: mild pain; 4-6: moderate pain; 7-10: severe pain.
The pain score after operation
The investigators evaluate and record the patients' pain score after operation by visual analog scale (VAS).
0-10 is used to represent different degrees of pain, 0 is painless and 10 is severe pain. The grading criteria of pain were: 0: no pain; 1-3: mild pain; 4-6: moderate pain; 7-10: severe pain.
The pain score after operation
The investigators evaluate and record the patients' pain score after operation by visual analog scale (VAS).
0-10 is used to represent different degrees of pain, 0 is painless and 10 is severe pain. The grading criteria of pain were: 0: no pain; 1-3: mild pain; 4-6: moderate pain; 7-10: severe pain.
Secondary Outcome Measures
The postoperative drainage
The investigators record the postoperative drainage of patients.The drainage of chest catheter or negative pressure ball was recorded by the nurse every day after surgery.
Less postoperative drainage means faster recovery and shorter discharge times.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05340517
Brief Title
Prospective Study of Video-assisted Rib Planting in Chest Wall Stabilization
Official Title
Prospective Study of Video-assisted Rib Planting in Chest Wall Stabilization
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
February 22, 2021 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
January 6, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Weigang Zhao
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this study is to compare the advantages and disadvantages of video-assisted rib planting and traditional internal fixation of rib fractures in chest wall stabilization.
The investigators design a new surgical method of video-assisted thoracoscopic surgery for rib fractures, evaluate the advantages and disadvantages of the new surgical techniques with a prospective study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rib Fractures, Rib Fracture Multiple
Keywords
internal fixation, video-assisted, chest wall stabilization, prospective study
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
video-assisted rib planting
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
video-assisted rib planting
Other Intervention Name(s)
video-assisted thoracoscopic surgery for rib fractures
Intervention Description
Give the patient intercostal nerve block and laryngeal mask anesthesia, after that, put the patient in lateral position. Make a 4-6cm posterolateral incision along the lower edge of the scapula，sever latissimus dorsi and serratus anterior and reach the rib surface. Lift the scapula with the abdominal retractor (or xiphoid retractor), Free adhesion tissue inside the scapula and put in the thoracoscopic lens. Free the tissue of the upper and lower edges of the ribs carefully, reset ribs and insert rib plate, which is fixed by 90° electric drill and locking screw.
Primary Outcome Measure Information:
Title
The pain score after operation
Description
The investigators evaluate and record the patients' pain score after operation by visual analog scale (VAS)，which is used to evaluate pain scores 6h,12h,and 24h after the operation.
0-10 is used to represent different degrees of pain, 0 is painless and 10 is severe pain. The grading criteria of pain were: 0: no pain; 1-3: mild pain; 4-6: moderate pain; 7-10: severe pain.
Time Frame
6 hours after operation
Title
The pain score after operation
Description
The investigators evaluate and record the patients' pain score after operation by visual analog scale (VAS).
0-10 is used to represent different degrees of pain, 0 is painless and 10 is severe pain. The grading criteria of pain were: 0: no pain; 1-3: mild pain; 4-6: moderate pain; 7-10: severe pain.
Time Frame
12 hours after operation
Title
The pain score after operation
Description
The investigators evaluate and record the patients' pain score after operation by visual analog scale (VAS).
0-10 is used to represent different degrees of pain, 0 is painless and 10 is severe pain. The grading criteria of pain were: 0: no pain; 1-3: mild pain; 4-6: moderate pain; 7-10: severe pain.
Time Frame
24 hours after operation
Secondary Outcome Measure Information:
Title
The postoperative drainage
Description
The investigators record the postoperative drainage of patients.The drainage of chest catheter or negative pressure ball was recorded by the nurse every day after surgery.
Less postoperative drainage means faster recovery and shorter discharge times.
Time Frame
7 days at most
Other Pre-specified Outcome Measures:
Title
The operation time
Description
The investigators record patients' operation time duration.
Time Frame
During surgery
Title
The length of incision
Description
The investigators record the length of operative incision.
Time Frame
During surgery
Title
The intraoperative bleeding
Description
The investigators record the intraoperative bleeding of patients.
Time Frame
During surgery
Title
The treatment costs
Description
The investigators record the treatment costs and calculate per capita treatment costs of patients,which is recorded and counted at the time of discharge.
Total treatment costs include hospitalization, treatment, surgery, medications, and other related expenses.
Time Frame
from the date of hospitalization to the date of leave hospital,assessed up to 100 months
Title
Days of stay hospital
Description
Days of stay hospital
Time Frame
from the date of hospitalization to the date of leave hospital,assessed up to 100 months
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:
-≥3 unilateral rib displacement fractures
18-70 years old
ASA score I-II
Preoperative arterial oxygen partial pressure >60mmHg
Carbon dioxide partial pressure <50mmHg
Exclusion Criteria:
The distance from the broken end of the posterior rib fracture to the spine is less than 2cm
Airway stenosis
Abnormal coagulation system
History of peptic ulcer or bleeding
History of allergy to anesthesia related drugs
History of asthma or chronic obstructive pulmonary emphysema
Pregnant women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weigang Zhao
Organizational Affiliation
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
City
Shanghai
Country
China
12. IPD Sharing Statement
Learn more about this trial
Prospective Study of Video-assisted Rib Planting in Chest Wall Stabilization
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