Acute Appendicitis Without PeritonitisPhase 4ASAANCT01421901
Antibiotics Versus Surgery in Acute Appendicitis
A Phase 4 study testing Ertapenem and appendectomy in people with Acute Appendicitis Without Peritonitis, run by A.O. Ospedale Papa Giovanni XXIII at 1 site in Italy.
Trial summary
The acute appendicitis (AA) is a very common disease with a life time risk 7-8% and the highest incidence in the second decades . The aetiology of AA is still poor understood: the commonest hypothesis refers to appendix obstruction followed by impairment of wall appendix barrier and thus wall perforation and/or… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Appendicitis Without Peritonitis
- What is being tested?
- Ertapenem and appendectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 1 siteItaly
- Study dates
- Aug 2011to Jun 2015
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients between 18 and 65 years old
- first episode of suspected AA diagnosed by Andersson's score or combination with abdominal ultrasound
Who cannot join
- patients with any potential immunodeficiency status
- assumption of antibiotics for different infectious disease or surgery in the last 30 days
- allergy to antibiotics established in the study protocol
- no acceptance of study protocol
- pregnancy or delivery in the last 6 months
- ASA IV or V, no Italian or English fluently speakers.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
1St General Surgery Unit Papa Giovanni XXIII Hospital Bergamo
Bergamo, 24127
About this study
Official title: Antibiotics vs.Surgery in Acute Appendicitis;an Intention to Treat Prospective Randomised Study. The ASAA-study
The acute appendicitis (AA) is a very common disease with a life time risk 7-8% and the highest incidence in the second decades . The aetiology of AA is still poor understood: the commonest hypothesis refers to appendix obstruction followed by impairment of wall appendix barrier and thus wall perforation and/or abscess formation1. However some studies suggest that no-complicate and complicate appendicitis are different entities allowing a different treatment. The study aims to test the no inferiority in terms of efficacy of antibiotic treatment compared to surgery in a population with high probability to suffer of 1st episode of AA.The study aims to test the no inferiority in terms of efficacy of antibiotic treatment compared to surgery in a population with high probability to suffer of 1st episode of AA.
- Conditions
- Acute Appendicitis Without Peritonitis
- Being tested
- Ertapenem, appendectomy
- Keywords
- Acute appendicitis, Surgery, Antibiotics, comparison surgery and antibiotics, resolutions of symptoms
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErtapenemDrug
Ertapenem i.v,m 1g, once a day, 3 days
appendectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Ertapenem | Experimental | Not described Receives: Drug: Ertapenem |
| appendectomy | Active comparator | Appendectomy is compared to Ertapenem Receives: Procedure: appendectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of patients free of symptoms into 2 weeks (from operation in the surgery group or from the third Ertapenem administration in the antibiotics group) with no pain, no fever, WBC ≤ 10000, CRP ≤ 1
Measured: 2 weeks
Secondary outcomes (1)
Secondary outcomes will be considered major complications occurring after 2 weeks and into 1 year. Phone consultation will be performed at 1 year
- Surgery: Rate of reintervention due to bowel occlusion (idro fluid level at Abdomen xRay and/no resolution by Gasytograffin) or intraperitoneal abscess; incisional hernia or wound dehiscence.
- Antibiotic:
Rate of Diagnosis of new AA. We will register also the rate of intervention for bowel occlusion longer than 48 hours (no passage of flatus, vomit or combination) or intraperitoneal abscess.
Further secondary outcome are Wound infection, negative appendectomy. Hospital stay and work absence.
Measured: 2 weeks- One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2014 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Appendicitis Without PeritonitisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 218 participants (estimated)
Sponsor and investigators
- Lead sponsor
- A.O. Ospedale Papa Giovanni XXIII
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Pisano, A.O. Ospedale Papa Giovanni XXIII
- Investigators
- Luca Ansaloni, Study director, Papa Giovanni XXIII Hospital BergamoMichele Pisano, Principal investigator, Papa Giovanni XXIII Hospital Bergamo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01421901
- Sponsor's protocol ID
- EUDRA CT Number 2011-002977-44
- Acronym
- ASAA
- Status last verified
- Jun 2014
- First submitted
- 4 Aug 2011
- Last updated
- 17 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotics vs.Surgery in Acute Appendicitis;an Intention to Treat Prospective Randomised Study. The ASAA-study
- ClinicalTrials.gov ID
- NCT01421901
- Acronym / sponsor ID
- ASAA / EUDRA CT Number 2011-002977-44
- Conditions
- Acute Appendicitis Without Peritonitis
- Keywords
- Acute appendicitis, Surgery, Antibiotics, comparison surgery and antibiotics, resolutions of symptoms
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 218 participants (estimated)
- Lead sponsor
- A.O. Ospedale Papa Giovanni XXIIIUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 23 Aug 2011 (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.
The acute appendicitis (AA) is a very common disease with a life time risk 7-8% and the highest incidence in the second decades . The aetiology of AA is still poor understood: the commonest hypothesis refers to appendix obstruction followed by impairment of wall appendix barrier and thus wall perforation and/or abscess formation1. However some studies suggest that no-complicate and complicate appendicitis are different entities allowing a different treatment. The study aims to test the no inferiority in terms of efficacy of antibiotic treatment compared to surgery in a population with high probability to suffer of 1st episode of AA.The study aims to test the no inferiority in terms of efficacy of antibiotic treatment compared to surgery in a population with high probability to suffer of 1st episode of AA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ertapenem | Experimental | Drug: Ertapenem |
| appendectomy | Active comparator | Procedure: appendectomyAppendectomy is compared to Ertapenem |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients between 18 and 65 years old
- first episode of suspected AA diagnosed by Andersson's score or combination with abdominal ultrasound
Key exclusion criteria (6 listed)
- patients with any potential immunodeficiency status
- assumption of antibiotics for different infectious disease or surgery in the last 30 days
- allergy to antibiotics established in the study protocol
- no acceptance of study protocol
- pregnancy or delivery in the last 6 months
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 |
|---|---|---|
| ErtapenemErtapenem i.v,m 1g, once a day, 3 days | Drug | Ertapenem |
| appendectomy | Procedure or surgery | appendectomy |
Primary outcome
the rate of patients free of symptoms into 2 weeks (from operation in the surgery group or from the third Ertapenem administration in the antibiotics group) with no pain, no fever, WBC ≤ 10000, CRP ≤ 1
Time frame: 2 weeks
1 secondary outcome
Secondary outcomes will be considered major complications occurring after 2 weeks and into 1 year. Phone consultation will be performed at 1 year
Time frame: 2 weeks- One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2014.
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.
Luca Ansaloni study director
Papa Giovanni XXIII Hospital Bergamo
Michele Pisano principal investigator
Papa Giovanni XXIII Hospital Bergamo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ertapenem and appendectomy in people with Acute Appendicitis Without Peritonitis, run by A.O. Ospedale Papa Giovanni XXIII at 1 site in Italy.
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 6 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: status not confirmed, as of the sponsor's last update on 17 Jun 2014. 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 Italy. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michele Pisano, Principal investigator (0039 0352673412, mpisano@hpg23.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the rate of patients free of symptoms into 2 weeks (from operation in the surgery group or from the third Ertapenem administration in the antibiotics group) with no pain, no fever, WBC ≤ 10000, CRP ≤ 1 (time frame: 2 weeks). 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 17 Jun 2014.