HemiarthroplastyNCT03076827
Effects of Surgery Start Time on Postoperative Interleukin-6, Interleukin-8, and Cortisol
A study testing Total hip replacement and Hemi-arthroplasty in people with Hemiarthroplasty and Arthroplasty, Replacement, Hip, run by Chuncheon Sacred Heart Hospital.
Trial summary
Cortisol is a hormone that increases after trauma or surgery and has circadian rhythm. It has a form that is increased in the morning and decreased in the evening. The investigators expected to be influenced by circadian rhythm according to the time of operation, and compared morning and afternoon surgery. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Hemiarthroplasty, Arthroplasty, Replacement, Hip
- What is being tested?
- Total hip replacement and Hemi-arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for hip hemiarthroplasty
- Patients scheduled for total hip replacement
Who cannot join
- Sleep disorder
- Mental disorder
- Psychiatric medication
About this study
Official title: Comparison of Cortisol and Cytokines in Morning and Afternoon Surgerys According to Circadian Rhythm of Cortisol
Cortisol is a hormone that increases after trauma or surgery and has circadian rhythm. It has a form that is increased in the morning and decreased in the evening. The investigators expected to be influenced by circadian rhythm according to the time of operation, and compared morning and afternoon surgery.
Read the detailed description
44 patients to undergo hip hemiarthroplasty or total hip replacement were divided to morning surgery group(Group A) and afternoon surgery group(Group P). All surgery was done by the same orthopedic surgeon. Anesthesia of Group A was started at 8 a.m. and Group P was at 12~2 p.m. Blood sampling was performed at 7:30 a.m., after induction of anesthesia, 6, 12, 24 and 48 hours after surgery in all patients of both groups. Cortisol, IL-6, and IL-8 was measured immediately after blood sampling. Visual analogue scale(VAS) was used to assess the degree of pain at before start of anesthesia, 6, 12, 24 and 48 hours after surgery. The postoperative hospital stay was calculated. Postoperative management was done by the same management team. Surgical wounds were treated at the same 24 hour intervals.
A sample size was calculated to differentiate between groups. Because difference of cortisol according to groups in ANOVA based on pilot study, the sample size was 20 patients per group. (Effect size f(v)= 0.5297047, α=0.05, 1-β=0.90) The investigators recruited total 44 patients to cover dropout 10%.
- Conditions
- Hemiarthroplasty, Arthroplasty, Replacement, Hip
- Being tested
- Total hip replacement, Hemi-arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total hip replacementProcedure or surgery
Total hip replacement starts in the morning in group A and starts in the afternoon in group P.
Hemi-arthroplastyProcedure or surgery
Hemi-arthroplasty starts in the morning in group A and starts in the afternoon in group P.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group to begin surgery(total hip replacement or hip hemi-arthroplasty) in the morning Receives: Procedure: Total hip replacement; Procedure: Hemi-arthroplasty |
| Group P | Experimental | Group to begin surgery(total hip replacement or hip hemi-arthroplasty) in the afternoon Receives: Procedure: Total hip replacement; Procedure: Hemi-arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortisol level
Cortisol levels over time
Measured: within the first 2 days after surgery
Secondary outcomes (4)
Interleukin-6
Interleukin-6 levels over time
Measured: within the first 2 days after surgery
Interleukin-8
Interleukin-8 levels over time
Measured: within the first 2 days after surgery
Visual analogue scale
pain scale over time
Measured: within the first 2 days after surgery
Post-operative hospital stay
Hospital day after surgery.
Measured: Hospital day after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2017
- Study startOct 2015
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HemiarthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients receiving total hip replacement or hip hemiarthroplasty are divided into two groups: the morning surgery group and the afternoon surgery group. After surgery, cortisol, IL-6, IL-8 and VAS were measured and compared.
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chuncheon Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae Jun Lee, Chuncheon Sacred Heart Hospital
- Investigators
- Jae Jun Lee, M.D., Principal investigator, Department of Anesthesiology and Pain medicine, Chuncheon Sacred Heart Hospital,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03076827
- Sponsor's protocol ID
- Chuncheon201701
- Status last verified
- Nov 2017
- First submitted
- 30 Jan 2017
- Last updated
- 14 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Popma A, Doreleijers TA, Jansen LM, Van Goozen SH, Van Engeland H, Vermeiren R. The diurnal cortisol cycle in delinquent male adolescents and normal controls. Neuropsychopharmacology. 2007 Jul;32(7):1622-8. doi: 10.1038/sj.npp.1301289. Epub 2007 Jan 17.
PubMed 17228341Kwon YS, Jang JS, Hwang SM, Tark H, Kim JH, Lee JJ. Effects of surgery start time on postoperative cortisol, inflammatory cytokines, and postoperative hospital day in hip surgery: Randomized controlled trial. Medicine (Baltimore). 2019 Jun;98(24):e15820. doi: 10.1097/MD.0000000000015820.
PubMed 31192911
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Cortisol and Cytokines in Morning and Afternoon Surgerys According to Circadian Rhythm of Cortisol
- ClinicalTrials.gov ID
- NCT03076827
- Acronym / sponsor ID
- Chuncheon201701
- Conditions
- Hemiarthroplasty, Arthroplasty, Replacement, Hip
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Chuncheon Sacred Heart HospitalUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 10 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cortisol is a hormone that increases after trauma or surgery and has circadian rhythm. It has a form that is increased in the morning and decreased in the evening. The investigators expected to be influenced by circadian rhythm according to the time of operation, and compared morning and afternoon surgery.
Detailed description
44 patients to undergo hip hemiarthroplasty or total hip replacement were divided to morning surgery group(Group A) and afternoon surgery group(Group P). All surgery was done by the same orthopedic surgeon. Anesthesia of Group A was started at 8 a.m. and Group P was at 12~2 p.m. Blood sampling was performed at 7:30 a.m., after induction of anesthesia, 6, 12, 24 and 48 hours after surgery in all patients of both groups. Cortisol, IL-6, and IL-8 was measured immediately after blood sampling. Visual analogue scale(VAS) was used to assess the degree of pain at before start of anesthesia, 6, 12, 24 and 48 hours after surgery. The postoperative hospital stay was calculated. Postoperative management was done by the same management team. Surgical wounds were treated at the same 24 hour intervals.
A sample size was calculated to differentiate between groups. Because difference of cortisol according to groups in ANOVA based on pilot study, the sample size was 20 patients per group. (Effect size f(v)= 0.5297047, α=0.05, 1-β=0.90) The investigators recruited total 44 patients to cover dropout 10%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients receiving total hip replacement or hip hemiarthroplasty are divided into two groups: the morning surgery group and the afternoon surgery group. After surgery, cortisol, IL-6, IL-8 and VAS were measured and compared.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: Total hip replacement, Procedure: Hemi-arthroplastyGroup to begin surgery(total hip replacement or hip hemi-arthroplasty) in the morning |
| Group P | Experimental | Procedure: Total hip replacement, Procedure: Hemi-arthroplastyGroup to begin surgery(total hip replacement or hip hemi-arthroplasty) in the afternoon |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled for hip hemiarthroplasty
- Patients scheduled for total hip replacement
Key exclusion criteria (3 listed)
- Sleep disorder
- Mental disorder
- Psychiatric medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total hip replacementTotal hip replacement starts in the morning in group A and starts in the afternoon in group P. | Procedure or surgery | Group A, Group P |
| Hemi-arthroplastyHemi-arthroplasty starts in the morning in group A and starts in the afternoon in group P. | Procedure or surgery | Group A, Group P |
Primary outcome
Cortisol level
Time frame: within the first 2 days after surgery
Cortisol levels over time
4 secondary outcomes
Interleukin-6
Time frame: within the first 2 days after surgery
Interleukin-8
Time frame: within the first 2 days after surgery
Visual analogue scale
Time frame: within the first 2 days after surgery
Post-operative hospital stay
Time frame: Hospital day after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2017.
- Background: PubMed 17228341Popma A, Doreleijers TA, Jansen LM, Van Goozen SH, Van Engeland H, Vermeiren R. The diurnal cortisol cycle in delinquent male adolescents and normal controls. Neuropsychopharmacology. 2007 Jul;32(7):1622-8. doi: 10.1038/sj.npp.1301289. Epub 2007 Jan 17.
- Derived from this study: PubMed 31192911Kwon YS, Jang JS, Hwang SM, Tark H, Kim JH, Lee JJ. Effects of surgery start time on postoperative cortisol, inflammatory cytokines, and postoperative hospital day in hip surgery: Randomized controlled trial. Medicine (Baltimore). 2019 Jun;98(24):e15820. doi: 10.1097/MD.0000000000015820.
- Click here for more information about background of this studyLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jae Jun Lee, M.D. principal investigator
Department of Anesthesiology and Pain medicine, Chuncheon Sacred Heart Hospital,
Questions about this trial
What is this clinical trial studying?
A study testing Total hip replacement and Hemi-arthroplasty in people with Hemiarthroplasty and Arthroplasty, Replacement, Hip, run by Chuncheon Sacred Heart Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cortisol level (time frame: within the first 2 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03076827, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2017.