Outcome of Surgical Fixation of Multiple Fractured Ribs a... | NCT05975762

Studies
Outcome of Surgical Fixation of Multiple Fractured Ribs at Sohag University Hospital

NCT05975762

Sponsor

Sohag University

Status

Unknown status

Last Update Posted

Aug 4, 2023Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Multiple Fractures of Ribs

Interventions

surgical rib fixation

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2023Estimated

Primary Completion Date

Jul 1, 2024Estimated

Completion Date

Aug 1, 2024Estimated

First Submitted Date

Jul 24, 2023

First Submission Date that Met QC Criteria

Aug 3, 2023

First Posted Date

Aug 4, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 3, 2023

Last Update Posted Date

Aug 4, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hossam Hassan Sayed, resident at cardiothoracic department, Sohag UniversityPrincipal Investigator

Lead Sponsor

Sohag UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The ribs are rigid and flexible structures that make up the chest skeleton and are a set of twelve paired bones. After Blunt trauma rib fractures incidence is about 30 to 40% [1].

Due to trauma, (4th -9th) ribs are often affected and the fracture point of the ribs is often on the midaxillary line. In ( 1st&2nd) ribs fractures subclavian vessels and brachial plexus damage may occur. In fractures in the lower ribs (8th-12th ribs), intra-abdominal organs injury such as liver, spleen and kidney should be investigated. 11-12. ribs fractures are rare because the ribs are more flexible (floating).

Pain is the most important symptom indicating rib fracture, and it usually increases with coughing, breathing, and movement. Broken rib ends can be felt with palpation with sever tenderness at the site of fracture. Pneumothorax and/or hemothorax may develop as a result of the sharp end of the broken rib causing lung parenchymal damage[2].

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
intervention group	Active Comparator	surgical fixation group	Procedure: surgical rib fixation
control group	No Intervention	conservation group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
surgical rib fixation	Procedure	open reduction and internal rib fixation	intervention group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
mechanical ventilation	the need and duration of mechanical ventilation	1 year
thoracic pain	measure severity of pain using pain scale 0 to10.	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

multiple fractured ribs pre ventilation

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hossam Hassan, resident	Contact	01147502309		hossamhassan@med.sohag.edu.eg
Ayman Abd Al-gafar, professor	Contact	01009899090

Overall Officials

Not provided

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30442372	Background	Marasco SF, Martin K, Niggemeyer L, Summerhayes R, Fitzgerald M, Bailey M. Impact of rib fixation on quality of life after major trauma with multiple rib fractures. Injury. 2019 Jan;50(1):119-124. doi: 10.1016/j.injury.2018.11.005. Epub 2018 Nov 3.
27572897	Background	Schuurmans J, Goslings JC, Schepers T. Operative management versus non-operative management of rib fractures in flail chest injuries: a systematic review. Eur J Trauma Emerg Surg. 2017 Apr;43(2):163-168. doi: 10.1007/s00068-016-0721-2. Epub 2016 Aug 29.

ID	Term
D000070799	Open Fracture Reduction
D005593	Fracture Fixation, Internal

ID	Term
D005592	Fracture Fixation
D019637	Orthopedic Procedures
D013812	Therapeutics
D013514	Surgical Procedures, Operative