Comparison of Day-time and Night-time Operations of Supracondylar Humeral Fractures

NCT ID: NCT04694469

Last Updated: 2021-01-05

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

COMPLETED

Total Enrollment

82 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-26

Study Completion Date

2020-01-21

Brief Summary

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This study aims to investigate that performing supracondylar humerus fracture operations during daylight hours may have better results than performing them at night.

Detailed Description

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Supracondylar humerus fractures are one of the most common traumatic fractures seen in children and their treatment usually requires immediate closed reduction and percutaneous pinning (CRPP). The presence of neurovascular complications associated with this fracture is considered an orthopedic emergency. For this reason, depending on the patient's operation time, the procedure should be performed at night under emergency conditions. Sleep deprivation, which is common in healthcare professionals, may affect patient safety due to disruptions in treatments and surgical procedures by reducing physician performance.

Conditions

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Supracondylar Fracture Morbidity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group Day

operated at 07:30 AM - 06:30 PM

Closed reduction and percutaneous pinning (CRPP)

Intervention Type PROCEDURE

Operated for supracondylar humeral fractures

Group Night

operated at 06:30 PM - 07:30 AM

Closed reduction and percutaneous pinning (CRPP)

Intervention Type PROCEDURE

Operated for supracondylar humeral fractures

Interventions

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Closed reduction and percutaneous pinning (CRPP)

Operated for supracondylar humeral fractures

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* aged 5 to 12 years
* had supracondylar humeral fractures,
* underwent CRPP
* under general anaesthesia
* American Society of Anesthesiologists (ASA) physical status I to III

Exclusion Criteria

* Surgical procedures outside the operating room
* parental refusing the study protocol
Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Istanbul University

OTHER

Sponsor Role lead

Responsible Party

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Nur Canbolat

Principal Investigator M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mehmet I. Buget, Assoc. Prof

Role: PRINCIPAL_INVESTIGATOR

Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology

Nur Canbolat, MD

Role: PRINCIPAL_INVESTIGATOR

Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology

Chasan Memet Chousein, MD

Role: PRINCIPAL_INVESTIGATOR

Istanbul Unıversity, Istanbul Faculty of Medicine, Orthopedics and Traumatology

Ali Ersen, Assoc. Prof

Role: STUDY_CHAIR

Istanbul Unıversit Istanbul Faculty of Medicine, Orthopedics and Traumatology

Kemalettin Koltka, Assoc. Prof

Role: STUDY_DIRECTOR

Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology

Locations

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Istanbul University, Faculty of Medicine

Istanbul, Fatih, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Tessler MJ, Charland L, Wang NN, Correa JA. The association of time of emergency surgery - day, evening or night - with postoperative 30-day hospital mortality. Anaesthesia. 2018 Nov;73(11):1368-1371. doi: 10.1111/anae.14329. Epub 2018 Aug 27.

Reference Type BACKGROUND
PMID: 30151989 (View on PubMed)

Chacko AT, Ramirez MA, Ramappa AJ, Richardson LC, Appleton PT, Rodriguez EK. Does late night hip surgery affect outcome? J Trauma. 2011 Aug;71(2):447-53; discussion 453. doi: 10.1097/TA.0b013e3182231ad7.

Reference Type BACKGROUND
PMID: 21825947 (View on PubMed)

Other Identifiers

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2019/266

Identifier Type: -

Identifier Source: org_study_id

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