AppendicitisPhase 2NCT00469430
Study of Conservative Versus Surgical Treatment of Appendicitis
A Phase 2 study testing cefotaxim and metronidazol in people with Appendicitis, run by Göteborg University at 1 site in Sweden.
Trial summary
The purpose of this study is to determine if antibiotic treatment of appendicitis is an option compared to surgery. The investigators' hypothesis is that a majority of patients with appendicitis can heal without surgery and that there are several advantages with antibiotic treatment related to time to recover… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Appendicitis
- What is being tested?
- cefotaxim and metronidazol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteSweden
- Study dates
- May 2006to Oct 2008
- Phase
- Phase 2
- 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
Who may be able to join
- Suspected appendicitis in patients over 18 years
Who cannot join
- Under 18 years
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Göteborg University, Sahlgrenska Universitetssjukhuset
Gothenburg, Göteborg
About this study
Official title: Randomized Study of Conservative Versus Surgical Treatment of Appendicitis; Analyses of Result and Economics
The purpose of this study is to determine if antibiotic treatment of appendicitis is an option compared to surgery. The investigators' hypothesis is that a majority of patients with appendicitis can heal without surgery and that there are several advantages with antibiotic treatment related to time to recover, complications and economical aspects.
Read the detailed description
Appendicitis is a common disease; 1/1000 gets it every year. 7% will get appendicitis during their lifetime. Surgery, open or laparoscopic, is the traditional treatment. A number of these patients don´t have appendicitis when operated on and the operation is therefore unnecessarily performed. It is also a risk for complications after surgery; for instance wound infection, postoperative small bowel obstruction.
In our study we will compare antibiotic as the only treatment with traditional surgical treatment. Patients with "suspected appendicitis" are randomized to either surgery or antibiotics according to their birth date.
Patients in "the surgery group" are treated according to standard routines. Patients in "the antibiotic group" are treated with intravenous antibiotics for at least 24h - this regime can be prolonged if clinical recovery doesn´t occur - and submitted from hospital with oral antibiotics. If patients in the antibiotic group deteriorate during the hospital stay (suspicious perforation) they will be operated.
Parameters that will be analyzed are:
- primary healing in the antibiotic group
- frequency of relapse in appendicitis in the antibiotic group
- complications in both groups
- economical analysis (hospital stay, sick leave time, time off work) in both groups
- Conditions
- Appendicitis
- Being tested
- cefotaxim and metronidazol
- Keywords
- appendicitis, treatment, antibiotics
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cefotaxim and metronidazolDrug
iv administration for at least 24 h
| Study group | Role | What they receive |
|---|---|---|
| Op | No intervention | traditional surgery |
| Ab | Experimental | antibiotic treatment Receives: Drug: cefotaxim and metronidazol |
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment efficacy
Measured: one year
Secondary outcomes (1)
complications
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2007 (estimated)
- Study startMay 2006
- Primary completionSep 2007
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AppendicitisStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Investigators
- Kent Lundholm, Principal investigator, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00469430
- Sponsor's protocol ID
- 1-Hansson
- Status last verified
- Apr 2009
- First submitted
- 3 May 2007
- Last updated
- 21 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Eriksson S, Granstrom L. Randomized controlled trial of appendicectomy versus antibiotic therapy for acute appendicitis. Br J Surg. 1995 Feb;82(2):166-9. doi: 10.1002/bjs.1800820207.
PubMed 7749676Styrud J, Eriksson S, Nilsson I, Ahlberg G, Haapaniemi S, Neovius G, Rex L, Badume I, Granstrom L. Appendectomy versus antibiotic treatment in acute appendicitis. a prospective multicenter randomized controlled trial. World J Surg. 2006 Jun;30(6):1033-7. doi: 10.1007/s00268-005-0304-6.
PubMed 16736333Hansson J, Korner U, Khorram-Manesh A, Solberg A, Lundholm K. Randomized clinical trial of antibiotic therapy versus appendicectomy as primary treatment of acute appendicitis in unselected patients. Br J Surg. 2009 May;96(5):473-81. doi: 10.1002/bjs.6482.
PubMed 19358184
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of Conservative Versus Surgical Treatment of Appendicitis; Analyses of Result and Economics
- ClinicalTrials.gov ID
- NCT00469430
- Acronym / sponsor ID
- 1-Hansson
- Conditions
- Appendicitis
- Keywords
- appendicitis, treatment, antibiotics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 4 May 2007 (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 purpose of this study is to determine if antibiotic treatment of appendicitis is an option compared to surgery. The investigators' hypothesis is that a majority of patients with appendicitis can heal without surgery and that there are several advantages with antibiotic treatment related to time to recover, complications and economical aspects.
Detailed description
Appendicitis is a common disease; 1/1000 gets it every year. 7% will get appendicitis during their lifetime. Surgery, open or laparoscopic, is the traditional treatment. A number of these patients don´t have appendicitis when operated on and the operation is therefore unnecessarily performed. It is also a risk for complications after surgery; for instance wound infection, postoperative small bowel obstruction.
In our study we will compare antibiotic as the only treatment with traditional surgical treatment. Patients with "suspected appendicitis" are randomized to either surgery or antibiotics according to their birth date.
Patients in "the surgery group" are treated according to standard routines. Patients in "the antibiotic group" are treated with intravenous antibiotics for at least 24h - this regime can be prolonged if clinical recovery doesn´t occur - and submitted from hospital with oral antibiotics. If patients in the antibiotic group deteriorate during the hospital stay (suspicious perforation) they will be operated.
Parameters that will be analyzed are:
- primary healing in the antibiotic group
- frequency of relapse in appendicitis in the antibiotic group
- complications in both groups
- economical analysis (hospital stay, sick leave time, time off work) in both groups
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Op | No intervention | –traditional surgery |
| Ab | Experimental | Drug: cefotaxim and metronidazolantibiotic treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Suspected appendicitis in patients over 18 years
Key exclusion criteria (1 listed)
- Under 18 years
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 |
|---|---|---|
| cefotaxim and metronidazoliv administration for at least 24 h | Drug | Ab |
Primary outcome
treatment efficacy
Time frame: one year
1 secondary outcome
complications
Time frame: one year
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 21 Apr 2009.
- Background: PubMed 7749676Eriksson S, Granstrom L. Randomized controlled trial of appendicectomy versus antibiotic therapy for acute appendicitis. Br J Surg. 1995 Feb;82(2):166-9. doi: 10.1002/bjs.1800820207.
- Background: PubMed 16736333Styrud J, Eriksson S, Nilsson I, Ahlberg G, Haapaniemi S, Neovius G, Rex L, Badume I, Granstrom L. Appendectomy versus antibiotic treatment in acute appendicitis. a prospective multicenter randomized controlled trial. World J Surg. 2006 Jun;30(6):1033-7. doi: 10.1007/s00268-005-0304-6.
- Derived from this study: PubMed 19358184Hansson J, Korner U, Khorram-Manesh A, Solberg A, Lundholm K. Randomized clinical trial of antibiotic therapy versus appendicectomy as primary treatment of acute appendicitis in unselected patients. Br J Surg. 2009 May;96(5):473-81. doi: 10.1002/bjs.6482.
Related trials for Appendicitis
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PAINED: Project Addressing INequities in the Emergency Department
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Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
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Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy
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Laparoscopic Antibiotic Lavage to Prevent Intra-abdominal Abscess Formation in Complicated Appendicitis
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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.
Kent Lundholm principal investigator
Göteborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cefotaxim and metronidazol in people with Appendicitis, run by Göteborg University 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 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 21 Apr 2009. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
treatment efficacy (time frame: one year). 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 NCT00469430, which also lists 3 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 21 Apr 2009.