- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03504878
Cost-effectiveness Analysis and Case-based Payment Norm Modeling on Appendicitis Patients at Hanoi Medical University Hospital
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Acute Appendicitis (AA) is a surgical emergency most common stomach. Appendicitis occurs at all ages. Recently, the rate tends to increase VRTC with age. In the United States, there are about 300,000 cases of appendectomy surgery per year. In Vietnam, according to statistics from a number of other authors showed that the rate of appendectomy surgery accounted for 40.5% - 49.8% of total number of cases of abdominal emergency. Open appendectomy (OA) has long been applied as the gold standard surgical procedure for the treatment of AA for over a century, since it was introduce by McBurrney in 1894 and still be common choice for procedure in many center. In 1981, due to the growth of endoscopic surgery, Semm first introduced the laparoscopic appendectomy, which render a minimal invasive procedure for abdomen and skin, nevertheless, its superiority over open appendectomy (OA) is still being debated. Some more recent paper demonstrate that Laparoscopic Appendectomy is the technique of choice in treatment of AA because of its clinical advantage and cost-effectiveness, however, more than 20 years later, the benefits of LA still remain a controversy for many researchers.
There are several studies comparing the cost-effectiveness between laparoscopic appendectomy and open appendectomy in the world. But in Vietnam, health economics studies for appendix removal surgery in general and laparoscopic appendectomy in particular has hardly been available, and in the context of reform of the financial mechanism for payment, questions about the cost-effectiveness between the two surgical methods are particularly concerned. Therefore, we conducted a study "Cost-effectiveness analysis and case-based payment norm modeling in patients with appendectomy at Hanoi Medical University Hospital" with two main purposes
- Analyze cost-effectiveness between laparoscopic and open surgery in patients undergoing appendectomy at Hanoi Medical University Hospital in 2011 - 2013
- Model case-based payment norm of appendectomy patients at Hanoi Medical University Hospital
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Hanoi, Vietnam, 10000
- Hanoi Medical University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Laparoscopic Appendectomy patients agree to participate in research and are paid by the mode of service charge
- Laparoscopic Appendectomy patients agree to participate in research and are paid according to package medical cases
Exclusion Criteria:
- Patients with combined pathology affecting surgical outcomes
- The patient did not agree to participate in research
- Patients do not comply with treatment
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Patients undergoing laparoscopic appendectomy
Appendix removal via scope.
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The laparoscopic appendectomy was performed with three trocars.
Pneumoperitoneum was created using an open Hasson technique.
The mesoappendix was divided using a harmonic scalpel or endoscopic tissue fusion device.
The appendix was divided by placing one endoscopic loop and cut with harmonic scalpel.
The specimen was removed through the umbilical port.
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Patients undergoing open appendectomy
Open operation for removal of appendix
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The open appendectomy was carried out in the standard way with McBurney muscle splitting incision.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average cost of hospitalization based on the final hospital bills
Time Frame: 2 years
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Total mean expense that patient pay for hospital after completing acute appendicitis treatment
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2 years
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Average Cost of medication
Time Frame: 2 years
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Total mean cost of drugs used during operation for removal of appendix
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2 years
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Overall treatment cost of acute appendicitis patient
Time Frame: From the beginning of hospital admission till discharge from hospital ((an expected average of 10 days, maximum 20 days)
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Total amount of money that acute appendicitis patient have to spend during the time of hospitalization
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From the beginning of hospital admission till discharge from hospital ((an expected average of 10 days, maximum 20 days)
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Case-based cost of appendectomy
Time Frame: 2 years
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The expenses that patient pay for surgical removal of appendix accounted by case-based standardisation
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2 years
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Cost of appendectomy based on health care services fee
Time Frame: 2 years
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The expenses that patient pay for acute appendicitis treatment accounted in accordance with services fee of hospital
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2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Length of hospital stay
Time Frame: from the beginning of the surgery till discharge from hospital (an expected average of 8 days, maximum 20 days)
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No. of days from surgery to discharge of hospital
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from the beginning of the surgery till discharge from hospital (an expected average of 8 days, maximum 20 days)
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Duration of post-operative pain
Time Frame: from the beginning of the surgery till discharge from hospital (an expected average of 8 days, maximum 20 days)
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No. of days that patient experience pain after surgery
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from the beginning of the surgery till discharge from hospital (an expected average of 8 days, maximum 20 days)
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Degree of post-operative pain
Time Frame: from the beginning of the surgery till discharge from hospital (an expected average of 8 days, maximum 20 days)
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Percentage of patients according to stratification of post-operative pain
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from the beginning of the surgery till discharge from hospital (an expected average of 8 days, maximum 20 days)
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Time until resumption of clear liquid and regular diet
Time Frame: from the beginning of the surgery to the resumption (an expected average 2 days after the surgery
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No. of days from surgery to the resumption of clear liquid and regular diet
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from the beginning of the surgery to the resumption (an expected average 2 days after the surgery
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Surgical outcome at hospital discharge
Time Frame: 2 years
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Percentage of patients with good outcome at hospital discharge
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2 years
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HMU16224
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
King Abdulaziz UniversityCompletedAppendicitis | Acute Appendicitis | Pathology | Appendicitis (Diagnosis)Saudi Arabia
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