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Cost-effectiveness Analysis and Case-based Payment Norm Modeling on Appendicitis Patients at Hanoi Medical University Hospital

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ClinicalTrials.gov Identifier: NCT03504878
Recruitment Status : Completed
First Posted : April 20, 2018
Last Update Posted : April 20, 2018
Sponsor:
Information provided by (Responsible Party):
Bui My Hanh, Hanoi Medical University

Brief Summary:
In the world, there are several studies comparing the cost-effectiveness between laparoscopic appendectomy and open appendectomy. But in Vietnam, health economics studies for acute appendicitis 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"

Condition or disease Intervention/treatment
Acute Appendicitis Procedure: Laparoscopic appendectomy Procedure: Open appendectomy

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

  1. Analyze cost-effectiveness between laparoscopic and open surgery in patients undergoing appendectomy at Hanoi Medical University Hospital in 2011 - 2013
  2. Model case-based payment norm of appendectomy patients at Hanoi Medical University Hospital

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Study Type : Observational
Actual Enrollment : 322 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Cost-effectiveness Analysis and Case-based Payment Norm Modeling on Appendicitis Patients at Hanoi Medical University Hospital
Actual Study Start Date : January 1, 2011
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : December 31, 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients undergoing laparoscopic appendectomy
Appendix removal via scope.
Procedure: Laparoscopic appendectomy
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.

Patients undergoing open appendectomy
Open operation for removal of appendix
Procedure: Open appendectomy
The open appendectomy was carried out in the standard way with McBurney muscle splitting incision.




Primary Outcome Measures :
  1. Average cost of hospitalization based on the final hospital bills [ Time Frame: 2 years ]
    Total mean expense that patient pay for hospital after completing acute appendicitis treatment

  2. Average Cost of medication [ Time Frame: 2 years ]
    Total mean cost of drugs used during operation for removal of appendix

  3. 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) ]
    Total amount of money that acute appendicitis patient have to spend during the time of hospitalization

  4. Case-based cost of appendectomy [ Time Frame: 2 years ]
    The expenses that patient pay for surgical removal of appendix accounted by case-based standardisation

  5. Cost of appendectomy based on health care services fee [ Time Frame: 2 years ]
    The expenses that patient pay for acute appendicitis treatment accounted in accordance with services fee of hospital


Secondary Outcome Measures :
  1. 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) ]
    No. of days from surgery to discharge of hospital

  2. 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) ]
    No. of days that patient experience pain after surgery

  3. 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) ]
    Percentage of patients according to stratification of post-operative pain

  4. 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 ]
    No. of days from surgery to the resumption of clear liquid and regular diet

  5. Surgical outcome at hospital discharge [ Time Frame: 2 years ]
    Percentage of patients with good outcome at hospital discharge



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients with clinical, laboratory, and radiological signs of acute appendicitis
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03504878


Locations
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Vietnam
Hanoi Medical University
Hanoi, Vietnam, 10000
Sponsors and Collaborators
Hanoi Medical University

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Responsible Party: Bui My Hanh, Director, Science Research and International Cooperation Unit, Hanoi Medical University
ClinicalTrials.gov Identifier: NCT03504878     History of Changes
Other Study ID Numbers: HMU16224
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Appendicitis
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases