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

NCT05340517 | Completed

• 1 other identifier: ZWG20210222
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Rib Fractures; Rib Fracture Multiple

Keywords

internal fixation; video-assisted; chest wall stabilization; prospective study

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• The postoperative drainage

  7 days at most

Other Outcomes (5)

• The operation time

  During surgery

• The length of incision

  During surgery

• The intraoperative bleeding

  During surgery

Study Arms (1)

video-assisted rib planting

EXPERIMENTAL

Procedure: video-assisted rib planting

Interventions

video-assisted rib planting PROCEDURE

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.

Also known as: video-assisted thoracoscopic surgery for rib fractures

video-assisted rib planting

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥3 unilateral rib displacement fractures
• years old
• ASA score I-II
• Preoperative arterial oxygen partial pressure \>60mmHg
• Carbon dioxide partial pressure \<50mmHg

You may not qualify if:

• 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

Sponsors & Collaborators

• Weigang Zhao: lead

Study Sites (1)

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Rib Fractures

Interventions

Thoracic Surgery, Video-Assisted

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Thoracic Injuries

Intervention Hierarchy (Ancestors)

Thoracoscopy; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Video-Assisted Surgery; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Study Officials

• Weigang Zhao

  Shanghai Jiao Tong University Affiliated Sixth People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: April 22, 2022
• Study Start: February 22, 2021
• Primary Completion: April 30, 2021
• Study Completion: January 6, 2022
• Last Updated: April 22, 2022

Record last verified: 2022-04

Locations

CN (1)