AppendicitisNCT00674726
Study on the Difference of Axilo-rectal Temperature in Appendicitis
An observational study of Appendicitis and Gastroenteritis, run by Cirujanos la Serena at 2 sites in Chile.
Trial summary
The investigators are studying prospectively the difference in axilo-rectal temperature in patients with acute appendicitis and using as a control group patients consulting with acute gastroenteritis at our emergency unit. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Appendicitis, Gastroenteritis
- What is being tested?
- Observation and measurement of axilo-rectal temperature
- How many people
- 0 participants
- Where
- 2 sitesChile
- Study dates
- May 2008to Jul 2008
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients consulting in the emergency unit with acute appendicitis or acute gastroenteritis
Who may be able to join
- Patients with acute appendicitis
- Patients with acute gastroenteritis
- Patients older than 15 years of age
Who cannot join
- Other acute abdominal diseases
Trial locations and contacts
2 sites in 1 country.
Chile2 sites
Hospital de La Serena - Emergency Unit
La Serena, Coquimbo Region
Hospital de La Serena
La Serena, Coquimbo Region
About this study
Official title: Prospective Study on the Difference of Axilar-rectal Temperature in Acute Appendicitis
The investigators are studying prospectively the difference in axilo-rectal temperature in patients with acute appendicitis and using as a control group patients consulting with acute gastroenteritis at our emergency unit.
- Conditions
- Appendicitis, Gastroenteritis
- Being tested
- Observation and measurement of axilo-rectal temperature
- Keywords
- appendicitis, gastroenteritis, temperature, fever, acute abdomen, Axilo-rectal temperature in appendicitis, Axilo-rectal temperature in gastroenteritis
- Medical subject headings
- Appendicitis, Gastroenteritis, Fever, Abdomen, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation and measurement of axilo-rectal temperatureOther
Measurement of axilo-rectal temperature
| Study group | Role | What they receive |
|---|---|---|
| Group I | Patients with acute appendicitis Receives: Other: Observation and measurement of axilo-rectal temperature | |
| Group II | Patients with acute gastroenteritis Receives: Other: Observation and measurement of axilo-rectal temperature |
What is being measured
The primary outcome is the main question the study is designed to answer.
The real difference in axilo-rectal temperature in patients with acute appendicitis
Measured: 6 hours
Secondary outcomes (1)
The differences in axilo-rectal temperature between patients with acute appendicitis and acute gastroenteritis
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2008 (estimated)
- Study startMay 2008
- Primary completionMay 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cirujanos la Serena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MARCELO A. BELTRAN, M.D., Cirujanos la Serena
- Investigators
- Marcelo A Beltran, M.D., Principal investigator, Hospital de La Serena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00674726
- Sponsor's protocol ID
- HLS-002-05-08
- Status last verified
- Oct 2012
- First submitted
- 6 May 2008
- Last updated
- 31 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study on the Difference of Axilar-rectal Temperature in Acute Appendicitis
- ClinicalTrials.gov ID
- NCT00674726
- Acronym / sponsor ID
- HLS-002-05-08
- Conditions
- Appendicitis, Gastroenteritis
- Keywords
- appendicitis, gastroenteritis, temperature, fever, acute abdomen, Axilo-rectal temperature in appendicitis, Axilo-rectal temperature in gastroenteritis
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cirujanos la SerenaUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- May 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 8 May 2008 (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 investigators are studying prospectively the difference in axilo-rectal temperature in patients with acute appendicitis and using as a control group patients consulting with acute gastroenteritis at our emergency unit.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | – | Other: Observation and measurement of axilo-rectal temperaturePatients with acute appendicitis |
| Group II | – | Other: Observation and measurement of axilo-rectal temperaturePatients with acute gastroenteritis |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients consulting in the emergency unit with acute appendicitis or acute gastroenteritis
Key inclusion criteria (3 listed)
- Patients with acute appendicitis
- Patients with acute gastroenteritis
- Patients older than 15 years of age
Key exclusion criteria (1 listed)
- Other acute abdominal diseases
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 |
|---|---|---|
| Observation and measurement of axilo-rectal temperatureMeasurement of axilo-rectal temperature | Other | Group I, Group II |
Primary outcome
The real difference in axilo-rectal temperature in patients with acute appendicitis
Time frame: 6 hours
1 secondary outcome
The differences in axilo-rectal temperature between patients with acute appendicitis and acute gastroenteritis
Time frame: 6 hours
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 31 Oct 2012.
Related trials for 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
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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.
Marcelo A Beltran, M.D. principal investigator
Hospital de La Serena
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Appendicitis and Gastroenteritis, run by Cirujanos la Serena at 2 sites in Chile.
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 3 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: withdrawn, as of the sponsor's last update on 31 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 2 sites in Chile. 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?
The real difference in axilo-rectal temperature in patients with acute appendicitis (time frame: 6 hours). 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 31 Oct 2012.