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The Out-patient, Non Antibiotic Management of Patients With Acute Uncomplicated Colonic Diverticulitis (P-VOD)

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ClinicalTrials.gov Identifier: NCT01515150
Recruitment Status : Completed
First Posted : January 23, 2012
Last Update Posted : January 26, 2015
Sponsor:
Information provided by (Responsible Party):
Uppsala University

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

Previous multicentre study NCT 01008488 indicates that a patient with CT-proven uncomplicated diverticulitis has a very low risk (1.4%) of developing severe complications such as perforations or abscesses. The question is whether or not hospitalization is necessary, and if patients in that case could return home without antibiotics.

The purpose of this study is to evaluate if out-patients managements in uncomplicated colonic diverticulitis is possible without readmission or complications.


Condition or disease
Colonic Diverticulitis

Detailed Description:
At the emergency room all patients with computed tomography verified acute uncomplicated diverticulitis will be asked about participation in the study. If They accept the participation, They will be send home with pain relief medicine. Every morning a nurse from our colorectal unit call the patient asking about the condition. The patients will have a visit at the surgery unit within 10 days.

Study Design
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Study Type : Observational
Actual Enrollment : 161 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Management of Patients With Uncomplicated Diverticulitis as Out-patient and Without Antibiotics
Study Start Date : February 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : August 2014

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U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
Out-patients in diverticulitis
All patient with acute uncomplicated diverticulitis how accept participation in the study will be enrolled in the study.


Outcome Measures
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Primary Outcome Measures :
  1. Number of admission and complications among participant within three months follow-up. [ Time Frame: Three months ]

Secondary Outcome Measures :
  1. To evaluate reason of hospital admission, late complications, need of bowel rest and costs [ Time Frame: Three months ]

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with CT- scan varified acute uncomplicated diverticulitis how are abel to underwent out-patients managment
Criteria

Inclusion Criteria:

  • Adults (age above 18 years, acute abdominal pain (Duration< 3 days), abdominal tenderness, elevated inflammatory parameters, CT- scan sign of uncomplicated diverticulitis(without sign of abscess or free air).

Exclusion Criteria:

  • diffuse peritonitis sepsis or abscess, drying Patients who are unable to intake of fluids orally, severe pain with need of repeated parenteral morphine treatment, immunological deficient patients incl. steroid treatment, pregnancy, dementia, patients who need hospitalization of other reasons
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01515150


Locations
Sweden
Colorectal unit, department of surgery Västmanland Hospital Västerås
Västerås, Västmanland, Sweden, 72189
Sponsors and Collaborators
Uppsala University
Investigators
Study Chair: Mats Enlund, Ass. Prof Centre of Clinical Research of Uppsala University, Västmanlands Hospital Västerås
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT01515150     History of Changes
Other Study ID Numbers: P-VOD
First Posted: January 23, 2012    Key Record Dates
Last Update Posted: January 26, 2015
Last Verified: January 2015

Keywords provided by Uppsala University:
diverticulitis
Out-patient management
Antibiotics

Additional relevant MeSH terms:
Diverticulitis
Diverticulitis, Colonic
Intraabdominal Infections
Infection
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Diverticulosis, Colonic
Colonic Diseases
Intestinal Diseases