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

April 19, 2018 updated by: Bui My Hanh, Hanoi Medical University
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"

Study Overview

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

Study Type

Observational

Enrollment (Actual)

322

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Hanoi, Vietnam, 10000
        • Hanoi Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult patients with clinical, laboratory, and radiological signs of acute appendicitis

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients undergoing laparoscopic appendectomy
Appendix removal via scope.
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
The open appendectomy was carried out in the standard way with McBurney muscle splitting incision.

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
Total mean expense that patient pay for hospital after completing acute appendicitis treatment
2 years
Average Cost of medication
Time Frame: 2 years
Total mean cost of drugs used during operation for removal of appendix
2 years
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
From the beginning of hospital admission till discharge from hospital ((an expected average of 10 days, maximum 20 days)
Case-based cost of appendectomy
Time Frame: 2 years
The expenses that patient pay for surgical removal of appendix accounted by case-based standardisation
2 years
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
2 years

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)
No. of days from surgery to discharge of hospital
from the beginning of the surgery till discharge from hospital (an expected average of 8 days, maximum 20 days)
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
from the beginning of the surgery till discharge from hospital (an expected average of 8 days, maximum 20 days)
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
from the beginning of the surgery till discharge from hospital (an expected average of 8 days, maximum 20 days)
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
from the beginning of the surgery to the resumption (an expected average 2 days after the surgery
Surgical outcome at hospital discharge
Time Frame: 2 years
Percentage of patients with good outcome at hospital discharge
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2011

Primary Completion (Actual)

December 31, 2016

Study Completion (Actual)

December 31, 2016

Study Registration Dates

First Submitted

April 12, 2018

First Submitted That Met QC Criteria

April 19, 2018

First Posted (Actual)

April 20, 2018

Study Record Updates

Last Update Posted (Actual)

April 20, 2018

Last Update Submitted That Met QC Criteria

April 19, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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

No

Studies a U.S. FDA-regulated device product

No

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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