A Prospective Randomized Controlled Study Comparing the Clinical Effects of Surgical and Non-surgical Treatment of Low Rib Fractures

NCT ID: NCT05758870

Last Updated: 2023-03-08

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

NOT_YET_RECRUITING

Total Enrollment

64 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-01

Study Completion Date

2025-12-31

Brief Summary

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The purpose of this study is to explore the difference between the clinical effects of surgical and non-surgical treatment for patients with low rib fracture, and to explore whether SSRF has more clinical treatment advantages in patients with low rib fracture in a randomized, controlled and prospective manner.

Detailed Description

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Conditions

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Rib Fracture Multiple

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Research Group

surgical stabilization of low rib fracures by internal fixation

surgical stabilization of low rib fratures

Intervention Type PROCEDURE

surgical stabiliazation of rib fractures by internal fixation

Controls Group

conservative treatment of low rib fractures

converstive treatment of low rib fratures

Intervention Type OTHER

chest wall fixation band

Interventions

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surgical stabilization of low rib fratures

surgical stabiliazation of rib fractures by internal fixation

Intervention Type PROCEDURE

converstive treatment of low rib fratures

chest wall fixation band

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with chest trauma only and unilateral low rib fractures Three rib fractures and more Displacement of the broken end of the fracture (bicortical fracture and not in the same line) Time from injury to hospital \< 24 hours Age 18-70 ASA grade I-II Preoperative arterial oxygen partial pressure \>60mmHg, carbon dioxide partial pressure \<50mmHg The participate is volunteer in the study and sign the informed consent Pain score( Number Rating Scale, NRS) \>5 under calm breathing

Exclusion Criteria

* Difficult airway History of esophageal reflux Myasthenia gravis Coagulation disorders Gastrointestinal ulcer Gastrointestinal bleeding Anesthetic drugs allergy history Asthma Chronic obstructive pulmonary disease Pregnant women
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Jiao Tong University Affiliated Sixth People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Wu Weiming

Thoracic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Weiming Wu

Role: CONTACT

18930172451

Other Identifiers

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20220815

Identifier Type: -

Identifier Source: org_study_id

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