Study on the Difference of Axilo-rectal Temperature in Ap... | NCT00674726

Studies
Study on the Difference of Axilo-rectal Temperature in Appendicitis

NCT00674726

Sponsor

Cirujanos la Serena

Status

Withdrawn

Last Update Posted

Oct 31, 2012Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Appendicitis
Gastroenteritis

Interventions

Observation and measurement of axilo-rectal temperature

Countries

Chile

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2012

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2008

Primary Completion Date

May 2008Actual

Completion Date

Jul 2008Actual

First Submitted Date

May 6, 2008

First Submission Date that Met QC Criteria

May 7, 2008

First Posted Date

May 8, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 29, 2012

Last Update Posted Date

Oct 31, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group I		Patients with acute appendicitis	Other: Observation and measurement of axilo-rectal temperature
Group II		Patients with acute gastroenteritis	Other: Observation and measurement of axilo-rectal temperature

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Observation and measurement of axilo-rectal temperature	Other	Measurement of axilo-rectal temperature	Group I Group II

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The real difference in axilo-rectal temperature in patients with acute appendicitis		6 hours

Secondary Outcomes

Measure	Description	Time Frame
The differences in axilo-rectal temperature between patients with acute appendicitis and acute gastroenteritis		6 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with acute appendicitis
Patients with acute gastroenteritis
Patients older than 15 years of age

Exclusion Criteria:

Other acute abdominal diseases

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients consulting in the emergency unit with acute appendicitis or acute gastroenteritis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marcelo A Beltran, M.D.	Hospital de La Serena	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital de La Serena - Emergency Unit		La Serena	Coquimbo Region		Chile
Hospital de La Serena

Condition Browse Module

MeSH Terms

ID	Term
D001064	Appendicitis
D005759	Gastroenteritis
D005334	Fever
D000006	Abdomen, Acute

Ancestor Terms

ID	Term
D059413	Intraabdominal Infections
D007239	Infections
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019370	Observation

Ancestor Terms

ID	Term
D008722	Methods
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided