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

Comparing the Efficacy of Conservative Treatment With Minimally Invasive Surgery in the Treatment of 2-4 Displaced Rib Fractures:A Prospective Randomized Controlled Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Surgery--Complications; Chest Trauma; Rib Fractures
• Intervention / Treatment: Procedure: surgical treatment; Procedure: Conservative treatment

Detailed 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

• Study Type: Interventional
• Enrollment (Anticipated): 238
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yang Li, PHD; Phone Number: 13122109923; Email: drliyang1991@163.com

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:

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

8. Women during pregnancy

9. Flail chest

10. Combined with severe craniocerebral trauma and external abdominal injuries

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

12. Self-administered analgesics after injury

13.Massive hemopneumothorax requires emergency surgery

14. Patients who cannot tolerate surgery

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: surgical treatment; Minimally invasive internal fixation under spontaneous respiratory anesthesia and analgesic treatment and chest strap fixation	Procedure: surgical treatment; surgical treatment and Conservative treatment; Procedure: Conservative treatment; Conservative treatment
EXPERIMENTAL: Conservative treatment; analgesic treatment and chest strap fixation	Procedure: Conservative treatment; Conservative treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage improvement of lung function FEV1(Forced expiratory volume in one second)	FEV1(Forced expiratory volume in one second)，FEV1% ：percentage of the expected value	FEV1%(One week after treatment)-FEV1%(Admitted)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage improvement of lung function FVC	FVC（forced vital capacity），FVC%：percentage of the expected value	FVC%(One week after treatment)-FVC%(Admitted)
Percentage improvement of lung function PEF	PEF（peak expiratory flow ），PEF%：percentage of the expected value	PEF%(One week after treatment)-PEF%(Admitted)
Pain index	visual analogue scale，VAS（0-10）0：no pain；10：severe pain	Admitted；One week after treatment；One month after treatment;Three month after treatment;Half a year;One year
Pleural effusion	Measured by chest CT	Admitted；One week after treatment；One month after treatment;Three month after treatment;Half a year;One year
Mortality rate	Deaths associated with this study	Admitted；One week after treatment；One month after treatment;Three month after treatment;Half a year;One year
Length of hospital stay	Length of hospital stay	Admitted；One week after treatment；One month after treatment;Three month after treatment;Half a year;One year
Cost of treatment	Sum of all treatment costs	One year
Chronic pain	Pain lasting more than three months（It is suggested in the related article that pain lasting more than 3 months is chronic pain）visual analogue scale，VAS（0-10）0：no pain；10：severe pain	Three month after treatment;Half a year;One year
Quality of Life score	The Barthel index of ADL	One week after treatment；One month after treatment;Three month after treatment;Half a year;One year
Time to resume routine work	Time to resume routine work	One week after treatment；One month after treatment;Three month after treatment;Half a year;One year
Duration of analgesic medication	Duration of analgesic medication	intraoperative；One week after treatment；One month after treatment;Three month after treatment;Half a year;One year

Collaborators and Investigators

• Sponsor: Shanghai 6th People's Hospital
• Investigators: Study Director: Yi Yang, PHD, Shanghai 6th People's Hospital; Study Chair: Zongli Gao, PHD, Shanghai 6th People's Hospital; Study Chair: Yonghong Zhao, PHD, Shanghai 6th People's Hospital; Study Chair: Weiming Wu, PHD, Shanghai 6th People's Hospital; Study Chair: Weigang Zhao, PHD, Shanghai 6th People's Hospital; Study Chair: Tiancheng Zhao, PHD, Shanghai 6th People's Hospital; Study Chair: Xiang Guo, PHD, Shanghai 6th People's Hospital; Study Chair: Lei Wang, PHD, Shanghai 6th People's Hospital; Study Chair: Weiwei He, PHD, Shanghai 6th People's Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 1, 2021
• Primary Completion (ANTICIPATED): June 10, 2023
• Study Completion (ANTICIPATED): June 30, 2024

Study Registration Dates

• First Submitted: August 15, 2020
• First Submitted That Met QC Criteria: September 7, 2020
• First Posted (ACTUAL): September 9, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 20, 2021
• Last Update Submitted That Met QC Criteria: January 17, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: rib fractrue;surgical treatment;Rapid recovery
• Additional Relevant MeSH Terms: Wounds and Injuries; Thoracic Injuries; Fractures, Bone; Rib Fractures
• Other Study ID Numbers: ynlc201908

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data will not be Shared with other researchers

Drug and device information, study documents

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