Status Approved
First Submitted Date
2018/02/20
Registered Date
2018/05/18
Last Updated Date
2018/04/26
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0002884 |
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Unique Protocol ID | 201704350001 |
Public/Brief Title | Comparison of postoperative outcomes of general versus neuroaxial anesthesia in elderly patients undergoing hip fracture surgery using Korean nationwide claims data |
Scientific Title | Comparison of postoperative outcomes of general versus neuroaxial anesthesia in elderly patients undergoing hip fracture surgery using Korean nationwide claims data |
Acronym | |
MFDS Regulated Study | No |
IND/IDE Protocol | No |
Registered at Other Registry | No |
Healthcare Benefit Approval Status |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted exempt |
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Board Approval Number | PAIK 2018-04-007 |
Approval Date | 2017-07-18 |
Institutional Review Board Name | Institutional Review Board of Inje University Seoul Paik Hospital |
Institutional Review Board Address | 9, Mareunnae-ro, Jung-gu, Seoul |
Institutional Review Board Telephone | 02-2270-0945 |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | SI RA BANG |
Title | MD,PhD |
Telephone | +82-2-2270-0094 |
Affiliation | Inje University Seoul Paik Hospital |
Address | 2-Ga Jeo-dong, Jung-Gu, Seoul, Republic of Korea |
Contact Person for Public Queries | |
Name | SI RA BANG |
Title | MD,PhD |
Telephone | +82-2-2270-0094 |
Affiliation | Inje University Seoul Paik Hospital |
Address | 2-Ga Jeo-dong, Jung-Gu, Seoul, Republic of Korea |
Contact Person for Updating Information | |
Name | SI RA BANG |
Title | MD,PhD |
Telephone | +82-2-2270-0094 |
Affiliation | Inje University Seoul Paik Hospital |
Address | 2-Ga Jeo-dong, Jung-Gu, Seoul, Republic of Korea |
4. Status
Study Site | Single | |
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Overall Recruitment Status | Active, not recruiting | |
Date of First Enrollment | 2017-08-01 Actual | |
Target Number of Participant | 100000 | |
Primary Completion Date | ||
Study Completion Date | ||
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Inje University | |
Recruitment Status | Active, not recruiting | |
Date of First Enrollment | 2017-08-01 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | National Research Foundation |
Organization Type | Government |
Project ID | 201704350001 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Inje University |
Organization Type | University |
7. Study Summary
Lay Summary | Aging population are fast growing especially in developed country. South Korea is one of the rapid changing society of elderly population which represents as aged society that defined as an elderly population is more than14% of the total population. Ha et al. reported that hip fracture incidence continues to increase, and the predicted increases will be a serious socioeconomic burden and a challenge for public health care managements in Korea. Hip fracture is usually associated with adverse complications including mortality that resulted medical and financial burden for the society. One of the most common and adverse complication of elderly hip fracture patients is delirium. It is associated increased rate of cognitive decline, institutionalization, and mortality. To decrease the mortality rate and postoperative delirium one of recommendation is choice of anesthesia method. Mode of anesthesia related mortality and outcome in geriatric patients are debated questions. There are some reports that most of the anesthesia related complication are multifactorial. However, in hip fracture surgery there are some reports that RA represents favorable outcome. We used nationwide database to evaluate the effects of anesthesia on postoperative outcome The primary outcome of this study was to evaluate the anesthetic method affect 30 day in hospital mortality in hip fracture surgery using nationwide database. Furthermore, we compared postoperative delirium which needed pharmacological intervention between general anesthesia and regional anesthesia. |
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8. Study Design
Study Type | Observational Study |
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Observational Study Model | Others |
Time Perspective | Retrospective |
Target Number of Participant | 100000 |
Cohort/Group Number | 2 |
Cohort/ Group 1 |
Cohort/Group Label patients undergoing hip fracture surgery aged older than 65 years under general anesthesia |
Cohort/Group Description all patients undergoing hip fracture surgery aged 65 years and older admitted to hospitals in Korea . The major inclusion criterion was admission with a principal diagnosis of femur neck fracture(S720) and trochanteric fracture(S721) as identified through the patient’s principal diagnosis recorded using the International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) code. We included those admissions who underwent at least one of the following surgical operations based on ICD-10-CM procedure codes: N0601, N0611, N0711, N2070, N0715, N2710, N1715, N4710, N1725, N4720. We included who received general anesthesia. |
|
Cohort/ Group 2 |
Cohort/Group Label patients undergoing hip fracture surgery aged older than 65 years under regional anesthesia |
Cohort/Group Description all patients undergoing hip fracture surgery aged 65 years and older admitted to hospitals in Korea . The major inclusion criterion was admission with a principal diagnosis of femur neck fracture(S720) and trochanteric fracture(S721) as identified through the patient’s principal diagnosis recorded using the International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) code. We included those admissions who underwent at least one of the following surgical operations based on ICD-10-CM procedure codes: N0601, N0611, N0711, N2070, N0715, N2710, N1715, N4710, N1725, N4720. We included who received regional(spinal and epidural) anesthesia. |
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Biospecimen Collection & Archiving |
Not collect nor Archive |
Biospecimen Description |
9. Subject Eligibility
Study Population Description | patients undergoing hip fracture surgery aged 65 years and older admitted to hospitals in Korea using national health insurance claims data |
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Sampling Method | principal diagnosis of femur neck fracture(S72.0) and trochanteric fracture(S72.1) as identified through the patient’s principal diagnosis recorded using the International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) code. We included those admissions who underwent at least one of the following surgical operations based on ICD-10-CM procedure codes: N0601, N0611, N0711, N2070, N0715, N2710, N1715, N4710, N1725, N4720. |
Condition(s)/Problem(s) |
* (S00-T98)Injury, poisoning and certain other consequences of external causes (S72.080)Fracture of other parts of neck of femur, closed |
Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 65Year~No Limit |
|
Description principal diagnosis of femur neck fracture(S72.0) and trochanteric fracture(S72.1) as identified through the patient’s principal diagnosis recorded using the International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) code. We included those admissions who underwent at least one of the following surgical operations based on ICD-10-CM procedure codes: N0601, N0611, N0711, N2070, N0715, N2710, N1715, N4710, N1725, N4720. We included who received general, spinal and epidural anesthesia. |
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Exclusion Criteria |
We excluded patients who received both general and regional anesthesia. For patients with diagnosis of multiple trauma or fracture ('S00-S70', 'S73-99', 'T07', 'T14') were excluded. Also, we excluded patients who underwent more than twice of the operations during the same period of admission. |
Healthy Volunteers | No |
10. Outcome Measure(s)
Type of Primary Outcome | Safety | |
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Primary Outcome(s) 1 | ||
Outcome | Thirty-day mortality |
|
Timepoint | postoperative 30 days |
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Secondary Outcome(s) 1 | ||
Outcome | occurrence of delirium |
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Timepoint | at least once during the indexed administration period |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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