AppendicitisCONSAPP PilotNCT01572558
Conservative Treatment of Acute Appendicitis in Children
A study testing Appendectomy and Conservative, non-surgical treatment in people with Appendicitis and Child, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
This is a feasibility study that will be performed at the Astrid Lindgren Children´s Hospital, Karolinska University Hospital, Stockholm, Sweden. It will involve 50 patients, randomized to either conservative, non-operative, treatment with antibiotics OR surgery. Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Appendicitis, Child
- What is being tested?
- Appendectomy and Conservative, non-surgical treatment
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2012to Oct 2012
- Phase
- Interventional
- 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 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children 5-15 years old with a clinical diagnosis of appendicitis that prior to the trial would have been subjected to a surgical intervention
Who cannot join
- Suspicion of perforated appendicitis on the basis of generalized peritonitis
- An appendiceal mass, diagnosed either by palpation or with radiology
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Conservative Treatment of Acute Appendicitis in Children Pilot Trial
This is a feasibility study that will be performed at the Astrid Lindgren Children´s Hospital, Karolinska University Hospital, Stockholm, Sweden. It will involve 50 patients, randomized to either conservative, non-operative, treatment with antibiotics OR surgery. The study will test an computerized randomization system, the availability of patients willing to participate in the trial and the trial protocol. The investigators will assess the characteristics of the patients who agree to participate in the study and those who do not. The investigators will explore short term outcome and design suitable long term outcome measures.
- Conditions
- Appendicitis, Child
- Being tested
- Appendectomy, Conservative, non-surgical treatment
- Keywords
- Appendectomy, Nonsurgical treatment with antibiotics
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AppendectomyProcedure or surgery
Also called Open appendectomy, Laparoscopic appendectomy
Standard surgical treatment, normally laparoscopic appendectomy
Conservative, non-surgical treatmentDrug
Also called Meronem®, Meropenem, Flagyl®, Metronidazol
Non-surgical treatment, intravenous and oral antibiotics. Meropenem and Metronidazol will be used as intravenous antibiotics, Ciprofloxacin and Metronidazol will be used as oral antibiotics.
| Study group | Role | What they receive |
|---|---|---|
| Appendectomy | Active comparator | Standard surgical treatment, appendectomy Receives: Procedure: Appendectomy |
| Conservative, non-surgical treatment | Experimental | Non-operative treatment with intravenous and oral antibiotics Receives: Drug: Conservative, non-surgical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of symptoms without significant complications
This outcome measure is designed to be similar between the two groups. It is measured in number of participants that fails its designated treatment.
Failure of treatment include abscess formation requiring treatment (prolonged antibiotic course or drainage), wound infection requiring intravenous antibiotics, wound dehiscence requiring treatment, prolonged ileus >5 days, length of stay >7 days, recurrent appendicitis, persistance of symptoms leading to surgery and negative appendectomy.
Measured: 30 days
Secondary outcomes (5)
Time in hospital
Number of days as inpatients after initiation of allocated treatment, ea. after randomization.
Measured: 7 days
Time to resolution of symptoms
In hours, to the time where there is no significant pain (VAS not more than 3), no temprature nor any anorexia.
Measured: 7 days
Abscess formation
As noted either in hospital or during follow up.
Measured: 7 days
Early complications
Wound infections, wound dehiscence, diarrhea etc.
Measured: 7 days
Pain
Measured after 12, 24 and 48 hours with the 0-10 Visual Analoge Scale.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2012 (estimated)
- Study startFeb 2012
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AppendicitisStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan Svensson, Karolinska University Hospital
- Investigators
- Jan F Svensson, MD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01572558
- Sponsor's protocol ID
- EA2011/4:8
- Acronym
- CONSAPP Pilot
- Status last verified
- Oct 2012
- First submitted
- 13 Feb 2012
- Last updated
- 17 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Patkova B, Svenningsson A, Almstrom M, Eaton S, Wester T, Svensson JF. Nonoperative Treatment Versus Appendectomy for Acute Nonperforated Appendicitis in Children: Five-year Follow Up of a Randomized Controlled Pilot Trial. Ann Surg. 2020 Jun;271(6):1030-1035. doi: 10.1097/SLA.0000000000003646.
PubMed 31800496Svensson JF, Patkova B, Almstrom M, Naji H, Hall NJ, Eaton S, Pierro A, Wester T. Nonoperative treatment with antibiotics versus surgery for acute nonperforated appendicitis in children: a pilot randomized controlled trial. Ann Surg. 2015 Jan;261(1):67-71. doi: 10.1097/SLA.0000000000000835.
PubMed 25072441
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conservative Treatment of Acute Appendicitis in Children Pilot Trial
- ClinicalTrials.gov ID
- NCT01572558
- Acronym / sponsor ID
- CONSAPP Pilot / EA2011/4:8
- Conditions
- Appendicitis, Child
- Keywords
- Appendectomy, Nonsurgical treatment with antibiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 6 Apr 2012 (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.
This is a feasibility study that will be performed at the Astrid Lindgren Children´s Hospital, Karolinska University Hospital, Stockholm, Sweden. It will involve 50 patients, randomized to either conservative, non-operative, treatment with antibiotics OR surgery. The study will test an computerized randomization system, the availability of patients willing to participate in the trial and the trial protocol. The investigators will assess the characteristics of the patients who agree to participate in the study and those who do not. The investigators will explore short term outcome and design suitable long term outcome measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Appendectomy | Active comparator | Procedure: AppendectomyStandard surgical treatment, appendectomy |
| Conservative, non-surgical treatment | Experimental | Drug: Conservative, non-surgical treatmentNon-operative treatment with intravenous and oral antibiotics |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children 5-15 years old with a clinical diagnosis of appendicitis that prior to the trial would have been subjected to a surgical intervention
Key exclusion criteria (2 listed)
- Suspicion of perforated appendicitis on the basis of generalized peritonitis
- An appendiceal mass, diagnosed either by palpation or with radiology
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 |
|---|---|---|
| AppendectomyAlso: Open appendectomy, Laparoscopic appendectomyStandard surgical treatment, normally laparoscopic appendectomy | Procedure or surgery | Appendectomy |
| Conservative, non-surgical treatmentAlso: Meronem®, Meropenem, Flagyl®, MetronidazolNon-surgical treatment, intravenous and oral antibiotics. Meropenem and Metronidazol will be used as intravenous antibiotics, Ciprofloxacin and Metronidazol will be used as oral antibiotics. | Drug | Conservative, non-surgical treatment |
Primary outcome
Resolution of symptoms without significant complications
Time frame: 30 days
This outcome measure is designed to be similar between the two groups. It is measured in number of participants that fails its designated treatment. Failure of treatment include abscess formation requiring treatment (prolonged antibiotic course or drainage), wound infection requiring intravenous antibiotics, wound dehiscence requiring treatment, prolonged ileus >5 days, length of stay >7 days, recurrent appendicitis, persistance of symptoms leading to surgery and negative appendectomy.
5 secondary outcomes
Time in hospital
Time frame: 7 days
Time to resolution of symptoms
Time frame: 7 days
Abscess formation
Time frame: 7 days
Early complications
Time frame: 7 days
Pain
Time frame: 48 hours
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 17 Oct 2012.
- Derived from this study: PubMed 31800496Patkova B, Svenningsson A, Almstrom M, Eaton S, Wester T, Svensson JF. Nonoperative Treatment Versus Appendectomy for Acute Nonperforated Appendicitis in Children: Five-year Follow Up of a Randomized Controlled Pilot Trial. Ann Surg. 2020 Jun;271(6):1030-1035. doi: 10.1097/SLA.0000000000003646.
- Derived from this study: PubMed 25072441Svensson JF, Patkova B, Almstrom M, Naji H, Hall NJ, Eaton S, Pierro A, Wester T. Nonoperative treatment with antibiotics versus surgery for acute nonperforated appendicitis in children: a pilot randomized controlled trial. Ann Surg. 2015 Jan;261(1):67-71. doi: 10.1097/SLA.0000000000000835.
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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.
Jan F Svensson, MD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Appendectomy and Conservative, non-surgical treatment in people with Appendicitis and Child, run by Karolinska University Hospital at 1 site in Sweden.
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 2 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 17 Oct 2012. 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 Sweden. 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 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?
Resolution of symptoms without significant complications (time frame: 30 days). 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 NCT01572558, which also lists 2 linked publications.
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 Oct 2012.