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NCT Number: NCT05340517

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.

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Key information

Conditions

Rib Fractures Fractures, Bone Rib Fracture Multiple Thoracic Injuries Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Shanghai, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: video-assisted thoracoscopic surgery for rib fractures

Primary outcomes

  1. The pain score after operation

    Time frame: 6 hours 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.

  2. The pain score after operation

    Time frame: 12 hours 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.

  3. The pain score after operation

    Time frame: 24 hours 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 outcomes

  1. The postoperative drainage

    Time frame: 7 days at most

    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.

Other outcomes

  1. The operation time

    Time frame: During surgery

    The investigators record patients' operation time duration.

  2. The length of incision

    Time frame: During surgery

    The investigators record the length of operative incision.

  3. The intraoperative bleeding

    Time frame: During surgery

    The investigators record the intraoperative bleeding of patients.

  4. The treatment costs

    Time frame: from the date of hospitalization to the date of leave hospital,assessed up to 100 months

    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.

  5. Days of stay hospital

    Time frame: from the date of hospitalization to the date of leave hospital,assessed up to 100 months

    Days of stay hospital

Sponsors and collaborators

Lead sponsor

Weigang Zhao

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Apr 22, 2022
Registry last updated
Apr 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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