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Comparing the Efficacy of Conservative Treatment With Minimally Invasive Surgery in the Treatment of Rib Fractures

Shanghai Jiao Tong University logo

Shanghai Jiao Tong University

Status

Not yet enrolling

Conditions

Chest Trauma
Surgery--Complications
Rib Fractures

Treatments

Procedure: surgical treatment
Procedure: Conservative treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT04541758
ynlc201908

Details and patient eligibility

About

Open, randomized, parallel controlled prospective clinical study design was used in this study.Subjects were patients with 2-4 displaced non-flail rib fractures.Operation group (Group 1) : minimally invasive internal fixation operation group under spontaneous breathing anesthesia.In the operation group of minimally invasive internal fixation under autonomic respiratory anesthesia, the fracture was determined preoperatively by chest CT+ three-dimensional reconstruction of the ribs, and the optimal incision location was determined. The fracture was exposed through as many small incisions as possible, and fixed with titanium plate or clon-type plate. During the operation, the autonomic respiratory anesthesia and paraviral nerve block technology was adopted.In the conservative group (group 2), routine treatment measures such as analgesia and chest strap fixed were adopted.The purpose of this study was to evaluate the safety, feasibility, and efficacy of minimally invasive and conservative treatment for rib fractures with different Numbers of displaced ends.

Full description

An open, randomized, parallel controlled prospective clinical study design type was used in this study. Subjects were patients with two to four displaced non-flail chest fractures of the ribs. Operation group (Group 1) : minimally invasive internal fixation operation group under spontaneous breathing anesthesia. In the operation group of minimally invasive internal fixation under autonomic respiratory anesthesia, the fracture was determined preoperatively by chest CT+ three-dimensional reconstruction of the ribs, and the optimal incision location was determined. The fracture was exposed through as many small incisions as possible, and fixed with titanium plate or clon-type plate. During the operation, the autonomic respiratory anesthesia and paraviral nerve block technology was adopted. In the conservative group (group 2), routine treatment measures such as analgesia, hemostasis and chest band fixation were adopted. The effects of the two treatments on lung function, pain index, complications and QoL were evaluated. It provides theoretical basis for the treatment of rib fracture

Enrollment

238 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Unilateral thoracic trauma, fractured ends of rib fractures displaced 2-4 places
  2. Displaced fracture(CT image shows double displacement of bone cortex) located in the 3rd to 10th rib
  3. The number of broken ends of displaced fractures is greater than that of undisplaced fractures
  4. The length of time from injury to hospitalization <24 hours
  5. Age range(18-70)
  6. ASA grade I-II
  7. BMI < 30
  8. Preoperative partial arterial oxygen pressure >60mmHg, partial arterial carbon dioxide pressure <50mmHg

Exclusion criteria

  1. Difficult airway
  2. History of esophageal reflux
  3. Myasthenia gravis
  4. Abnormal coagulation system
  5. History of gastrointestinal ulcer or bleeding
  6. History of anaesthesia related drug allergy

A history of asthma or chronic obstructive emphysema

  1. Women during pregnancy

  2. Flail chest

  3. Combined with severe craniocerebral trauma and external abdominal injuries

  4. Recent use of clopidogrel, warfarin and aspirin seriously affects blood clotting

  5. Self-administered analgesics after injury

13.Massive hemopneumothorax requires emergency surgery

  1. Patients who cannot tolerate surgery

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

238 participants in 2 patient groups

surgical treatment
Experimental group
Description:
Minimally invasive internal fixation under spontaneous respiratory anesthesia and analgesic treatment and chest strap fixation
Treatment:
Procedure: surgical treatment
Procedure: Conservative treatment
Conservative treatment
Experimental group
Description:
analgesic treatment and chest strap fixation
Treatment:
Procedure: Conservative treatment

Trial contacts and locations

0

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Central trial contact

Yang Li, PHD

Data sourced from clinicaltrials.gov

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