Acute AppendicitisPhase 4NCT02867072
Laparoscopic Versus Open Appendectomy
A Phase 4 study testing Open appendectomy and Laparoscopic appendectomy in people with Acute Appendicitis, run by University of Catania.
Trial summary
Appendectomy is the most common surgical procedure performed in emergency surgery. Because of lack of consensus about the most appropriate technique, appendectomy is still being performed by both open (OA) and laparoscopic (LA) methods. Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Acute Appendicitis
- What is being tested?
- Open appendectomy and Laparoscopic appendectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 593 participants
- Where
- No sites listed yet
- Study dates
- Jan 2004to Jul 2011
- Phase
- Phase 4
- 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 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- acute appendicitis
Who cannot join
- Pregnant women and patients with severe medical disease (hemodynamic instability, chronic medical or psychiatric illness, cirrhosis, coagulation disorders) requiring intensive care
About this study
Official title: Laparoscopic Versus Open Appendectomy: A Retrospective Cohort Study Assessing Outcomes and Cost-effectiveness
Appendectomy is the most common surgical procedure performed in emergency surgery. Because of lack of consensus about the most appropriate technique, appendectomy is still being performed by both open (OA) and laparoscopic (LA) methods. In this retrospective analysis, the investigators aimed to compare the laparoscopic approach and the conventional technique in the treatment of acute appendicitis.
- Conditions
- Acute Appendicitis
- Being tested
- Open appendectomy, Laparoscopic appendectomy
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open appendectomyProcedure or surgery
Laparoscopic appendectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Open appendectomy | Active comparator | Subjects that underwent open surgery for appendicitis Receives: Procedure: Open appendectomy |
| Laparoscopic appendectomy | Active comparator | Subjects that underwent laparoscopic surgery for appendicitis Receives: Procedure: Laparoscopic appendectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital cost
Mean hospital cost (in Euro) for patients that underwent appendectomy
Measured: 3 days
Wound infection
Number of patients with wound infection after appendectomy
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2016 (estimated)
- Study startJan 2004
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 593 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Catania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Vacante, University of Catania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02867072
- Sponsor's protocol ID
- 01/2004
- Status last verified
- Aug 2016
- First submitted
- 8 Aug 2016
- Last updated
- 16 Aug 2016
- Results posted
- No
Publications
Biondi A, Di Stefano C, Ferrara F, Bellia A, Vacante M, Piazza L. Laparoscopic versus open appendectomy: a retrospective cohort study assessing outcomes and cost-effectiveness. World J Emerg Surg. 2016 Aug 30;11(1):44. doi: 10.1186/s13017-016-0102-5. eCollection 2016.
PubMed 27582784
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Versus Open Appendectomy: A Retrospective Cohort Study Assessing Outcomes and Cost-effectiveness
- ClinicalTrials.gov ID
- NCT02867072
- Acronym / sponsor ID
- 01/2004
- Conditions
- Acute Appendicitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 593 participants (actual)
- Lead sponsor
- University of CataniaUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 15 Aug 2016 (estimated)
- 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.
Appendectomy is the most common surgical procedure performed in emergency surgery. Because of lack of consensus about the most appropriate technique, appendectomy is still being performed by both open (OA) and laparoscopic (LA) methods. In this retrospective analysis, the investigators aimed to compare the laparoscopic approach and the conventional technique in the treatment of acute appendicitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open appendectomy | Active comparator | Procedure: Open appendectomySubjects that underwent open surgery for appendicitis |
| Laparoscopic appendectomy | Active comparator | Procedure: Laparoscopic appendectomySubjects that underwent laparoscopic surgery for appendicitis |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- acute appendicitis
Key exclusion criteria (1 listed)
- Pregnant women and patients with severe medical disease (hemodynamic instability, chronic medical or psychiatric illness, cirrhosis, coagulation disorders) requiring intensive care
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 |
|---|---|---|
| Open appendectomy | Procedure or surgery | Open appendectomy |
| Laparoscopic appendectomy | Procedure or surgery | Laparoscopic appendectomy |
Primary outcome
Hospital cost
Time frame: 3 days
Mean hospital cost (in Euro) for patients that underwent appendectomy
Wound infection
Time frame: 1 week
Number of patients with wound infection after appendectomy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2016.
- Derived from this study: PubMed 27582784Biondi A, Di Stefano C, Ferrara F, Bellia A, Vacante M, Piazza L. Laparoscopic versus open appendectomy: a retrospective cohort study assessing outcomes and cost-effectiveness. World J Emerg Surg. 2016 Aug 30;11(1):44. doi: 10.1186/s13017-016-0102-5. eCollection 2016.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Open appendectomy and Laparoscopic appendectomy in people with Acute Appendicitis, run by University of Catania.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 16 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Hospital cost (time frame: 3 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02867072, which also lists 1 linked publication.
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 16 Aug 2016.