Prospective Study of Video-assisted Rib Planting in Chest Wall Stabilization

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.

Study Overview

• Status: Completed
• Conditions: Rib Fractures; Rib Fracture Multiple
• Intervention / Treatment: Procedure: video-assisted rib planting

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: video-assisted rib planting

Procedure: video-assisted rib planting; 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.; Other Names: video-assisted thoracoscopic surgery for rib fractures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 hours after operation
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.	12 hours after operation
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.	24 hours after operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	7 days at most

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The operation time	The investigators record patients' operation time duration.	During surgery
The length of incision	The investigators record the length of operative incision.	During surgery
The intraoperative bleeding	The investigators record the intraoperative bleeding of patients.	During surgery
The treatment costs	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.	from the date of hospitalization to the date of leave hospital,assessed up to 100 months
Days of stay hospital	Days of stay hospital	from the date of hospitalization to the date of leave hospital,assessed up to 100 months

Collaborators and Investigators

• Sponsor: Weigang Zhao
• Investigators: Principal Investigator: Weigang Zhao, Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2021
• Primary Completion (Actual): April 30, 2021
• Study Completion (Actual): January 6, 2022

Study Registration Dates

• First Submitted: February 14, 2022
• First Submitted That Met QC Criteria: April 15, 2022
• First Posted (Actual): April 22, 2022

Study Record Updates

• Last Update Posted (Actual): April 22, 2022
• Last Update Submitted That Met QC Criteria: April 15, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: prospective study; internal fixation; video-assisted; chest wall stabilization
• Additional Relevant MeSH Terms: Wounds and Injuries; Thoracic Injuries; Multiple Trauma; Fractures, Bone; Rib Fractures; Fractures, Multiple
• Other Study ID Numbers: ZWG20210222

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No