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

NCT ID: NCT04541758

Last Updated: 2021-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

238 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2024-06-30

Brief Summary

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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.

Detailed Description

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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

Conditions

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Chest Trauma Rib Fractures Surgery--Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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surgical treatment

Minimally invasive internal fixation under spontaneous respiratory anesthesia and analgesic treatment and chest strap fixation

Group Type EXPERIMENTAL

surgical treatment

Intervention Type PROCEDURE

surgical treatment and Conservative treatment

Conservative treatment

Intervention Type PROCEDURE

Conservative treatment

Conservative treatment

analgesic treatment and chest strap fixation

Group Type EXPERIMENTAL

Conservative treatment

Intervention Type PROCEDURE

Conservative treatment

Interventions

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surgical treatment

surgical treatment and Conservative treatment

Intervention Type PROCEDURE

Conservative treatment

Conservative treatment

Intervention Type PROCEDURE

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai 6th People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Li Yang

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yi Yang, PHD

Role: STUDY_DIRECTOR

Shanghai 6th People's Hospital

Zongli Gao, PHD

Role: STUDY_CHAIR

Shanghai 6th People's Hospital

Yonghong Zhao, PHD

Role: STUDY_CHAIR

Shanghai 6th People's Hospital

Weiming Wu, PHD

Role: STUDY_CHAIR

Shanghai 6th People's Hospital

Weigang Zhao, PHD

Role: STUDY_CHAIR

Shanghai 6th People's Hospital

Tiancheng Zhao, PHD

Role: STUDY_CHAIR

Shanghai 6th People's Hospital

Xiang Guo, PHD

Role: STUDY_CHAIR

Shanghai 6th People's Hospital

Lei Wang, PHD

Role: STUDY_CHAIR

Shanghai 6th People's Hospital

Weiwei He, PHD

Role: STUDY_CHAIR

Shanghai 6th People's Hospital

Central Contacts

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Yang Li, PHD

Role: CONTACT

13122109923

Other Identifiers

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ynlc201908

Identifier Type: -

Identifier Source: org_study_id

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