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

Rib Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05340517
• Other study ID #: ZWG20210222
• Status: Completed
• Phase: N/A
• Start date: February 22, 2021
• Est. completion date: January 6, 2022

Study information

• Verified date: April 2022
• Source: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 6, 2022
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Rib Fracture Multiple
• Rib Fractures

Intervention

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.

Locations

Country	Name	City	State
China	Shanghai Jiao Tong University Affiliated Sixth People's Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Weigang Zhao

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The operation time	The investigators record patients' operation time duration.	During surgery
Other	The length of incision	The investigators record the length of operative incision.	During surgery
Other	The intraoperative bleeding	The investigators record the intraoperative bleeding of patients.	During surgery
Other	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
Other	Days of stay hospital	Days of stay hospital	from the date of hospitalization to the date of leave hospital,assessed up to 100 months
Primary	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
Primary	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
Primary	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	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