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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03504878
Other study ID # HMU16224
Secondary ID
Status Completed
Phase
First received April 12, 2018
Last updated April 19, 2018
Start date January 1, 2011
Est. completion date December 31, 2016

Study information

Verified date April 2018
Source Hanoi Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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"


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


Recruitment information / eligibility

Status Completed
Enrollment 322
Est. completion date December 31, 2016
Est. primary completion date December 31, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
Open appendectomy
The open appendectomy was carried out in the standard way with McBurney muscle splitting incision.

Locations

Country Name City State
Vietnam Hanoi Medical University Hanoi

Sponsors (1)

Lead Sponsor Collaborator
Hanoi Medical University

Country where clinical trial is conducted

Vietnam, 

Outcome

Type Measure Description Time frame Safety issue
Primary Average cost of hospitalization based on the final hospital bills Total mean expense that patient pay for hospital after completing acute appendicitis treatment 2 years
Primary Average Cost of medication Total mean cost of drugs used during operation for removal of appendix 2 years
Primary Overall treatment cost of acute appendicitis patient 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)
Primary Case-based cost of appendectomy The expenses that patient pay for surgical removal of appendix accounted by case-based standardisation 2 years
Primary Cost of appendectomy based on health care services fee The expenses that patient pay for acute appendicitis treatment accounted in accordance with services fee of hospital 2 years
Secondary Length of hospital stay 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)
Secondary Duration of post-operative pain 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)
Secondary Degree of post-operative pain 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)
Secondary Time until resumption of clear liquid and regular diet 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
Secondary Surgical outcome at hospital discharge Percentage of patients with good outcome at hospital discharge 2 years
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