Acute AppendicitisNCT03504878
Cost-effectiveness Analysis and Case-based Payment Norm Modeling on Appendicitis Patients at Hanoi Medical University Hospital
An observational study of Acute Appendicitis, run by Hanoi Medical University at 1 site in Vietnam.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Appendicitis
- What is being tested?
- Laparoscopic appendectomy and Open appendectomy
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Jan 2011to 31 Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with clinical, laboratory, and radiological signs of acute appendicitis
Who may be able to join
- 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
Who cannot join
- Patients with combined pathology affecting surgical outcomes
- The patient did not agree to participate in research
- Patients do not comply with treatment
Trial locations and contacts
1 site in 1 country.
About this study
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"
Read the 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
- Conditions
- Acute Appendicitis
- Being tested
- Laparoscopic appendectomy, Open appendectomy
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic appendectomyProcedure or surgery
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 appendectomyProcedure or surgery
The open appendectomy was carried out in the standard way with McBurney muscle splitting incision.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing laparoscopic appendectomy | Appendix removal via scope. Receives: Procedure: Laparoscopic appendectomy | |
| Patients undergoing open appendectomy | Open operation for removal of appendix Receives: Procedure: Open appendectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average cost of hospitalization based on the final hospital bills
Total mean expense that patient pay for hospital after completing acute appendicitis treatment
Measured: 2 years
Average Cost of medication
Total mean cost of drugs used during operation for removal of appendix
Measured: 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
Measured: 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
Measured: 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
Measured: 2 years
Secondary outcomes (5)
Length of hospital stay
No. of days from surgery to discharge of hospital
Measured: from the beginning of the surgery till discharge from hospital (an expected average of 8 days, maximum 20 days)
Duration of post-operative pain
No. of days that patient experience pain after surgery
Measured: from the beginning of the surgery till discharge from hospital (an expected average of 8 days, maximum 20 days)
Degree of post-operative pain
Percentage of patients according to stratification of post-operative pain
Measured: 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
No. of days from surgery to the resumption of clear liquid and regular diet
Measured: from the beginning of the surgery to the resumption (an expected average 2 days after the surgery
Surgical outcome at hospital discharge
Percentage of patients with good outcome at hospital discharge
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2018
- Study start1 Jan 2011 (estimated)
- Primary completion31 Dec 2016 (estimated)
- Study completion31 Dec 2016 (estimated)
Why it stopped: After further evaluation, the secondary data source was determined to be insufficient to address the study objectives. No prospective patient enrollment was planned, and the study was not initiated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute AppendicitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanoi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bui My Hanh, Hanoi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03504878
- Sponsor's protocol ID
- HMU16224
- Status last verified
- Apr 2018
- First submitted
- 12 Apr 2018
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-effectiveness Analysis and Case-based Payment Norm Modeling on Appendicitis Patients at Hanoi Medical University Hospital
- ClinicalTrials.gov ID
- NCT03504878
- Acronym / sponsor ID
- HMU16224
- Conditions
- Acute Appendicitis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: After further evaluation, the secondary data source was determined to be insufficient to address the study objectives. No prospective patient enrollment was planned, and the study was not initiated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hanoi Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2011 (estimated)
- Primary completion
- 31 Dec 2016 (estimated)
- Study completion
- 31 Dec 2016 (estimated)
- First posted
- 20 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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"
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing laparoscopic appendectomy | – | Procedure: Laparoscopic appendectomyAppendix removal via scope. |
| Patients undergoing open appendectomy | – | Procedure: Open appendectomyOpen operation for removal of appendix |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with clinical, laboratory, and radiological signs of acute appendicitis
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Patients with combined pathology affecting surgical outcomes
- The patient did not agree to participate in research
- Patients do not comply with treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic appendectomyThe 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. | Procedure or surgery | Patients undergoing laparoscopic appendectomy |
| Open appendectomyThe open appendectomy was carried out in the standard way with McBurney muscle splitting incision. | Procedure or surgery | Patients undergoing open appendectomy |
Primary outcome
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
Average Cost of medication
Time frame: 2 years
Total mean cost of drugs used during operation for removal of appendix
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
Case-based cost of appendectomy
Time frame: 2 years
The expenses that patient pay for surgical removal of appendix accounted by case-based standardisation
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
5 secondary outcomes
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)
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)
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)
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
Surgical outcome at hospital discharge
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: Yes
Related trials for Acute Appendicitis
RecruitingObservational study
Prospective Comparison of Pro-Adrenomedullin, C-Reactive Protein, and Neutrophil-to-Lymphocyte Ratio for Diagnosing Acute Appendicitis
Acute Appendicitis
Active, not recruiting
PAINED: Project Addressing INequities in the Emergency Department
Pain, Appendicitis
Not yet recruiting
Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
Appendicitis, Perforated Appendicitis
Recruiting
Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Acute Appendicitis
Not yet recruitingPhase 3
Piperacillin/Tazobactam Versus Ceftriaxone and Metronidazole for Children With Perforated Appendicitis
Appendicitis Perforated, Appendectomy, Laparoscopic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Appendicitis, run by Hanoi Medical University at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average cost of hospitalization based on the final hospital bills (time frame: 2 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.