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

NCT03504878 | Completed

• 1 other identifier: HMU16224
• Study Type: observational
• Target: 322
• Locations: 1 country
• Sites: 1

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"

Conditions

Acute Appendicitis

Outcome Measures

Primary Outcomes (5)

• 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

• Average Cost of medication

  Total mean cost of drugs used during operation for removal of appendix

  2 years

• 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)

• Case-based cost of appendectomy

  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

  The expenses that patient pay for acute appendicitis treatment accounted in accordance with services fee of hospital

  2 years

Secondary Outcomes (5)

• Length of hospital stay

  from the beginning of the surgery till discharge from hospital (an expected average of 8 days, maximum 20 days)

• Duration of post-operative pain

  from the beginning of the surgery till discharge from hospital (an expected average of 8 days, maximum 20 days)

• Degree 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

  from the beginning of the surgery to the resumption (an expected average 2 days after the surgery

• Surgical outcome at hospital discharge

  2 years

Study Arms (2)

Patients undergoing laparoscopic appendectomy

Appendix removal via scope.

Procedure: Laparoscopic appendectomy

Patients undergoing open appendectomy

Open operation for removal of appendix

Procedure: Open appendectomy

Interventions

Laparoscopic appendectomy PROCEDURE

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 laparoscopic appendectomy

Open appendectomy PROCEDURE

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

Patients undergoing open appendectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Patients with combined pathology affecting surgical outcomes
• The patient did not agree to participate in research
• Patients do not comply with treatment

Sponsors & Collaborators

• Hanoi Medical University: lead

Study Sites (1)

Hanoi Medical University

Hanoi, 10000, Vietnam

Location

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Science Research and International Cooperation Unit

Study Record Dates

• First Submitted: April 12, 2018
• First Posted: April 20, 2018
• Study Start: January 1, 2011
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: April 20, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

VN (1)