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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01515150
Recruitment Status : Completed
First Posted : January 23, 2012
Last Update Posted : January 26, 2015
Information provided by (Responsible Party):
Uppsala University

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.

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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

Resource links provided by the National Library of Medicine

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

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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
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

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01515150

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Colorectal unit, department of surgery Västmanland Hospital Västerås
Västerås, Västmanland, Sweden, 72189
Sponsors and Collaborators
Uppsala University
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Study Chair: Mats Enlund, Ass. Prof Centre of Clinical Research of Uppsala University, Västmanlands Hospital Västerås
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Responsible Party: Uppsala University Identifier: NCT01515150    
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:
Out-patient management
Additional relevant MeSH terms:
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Diverticulitis, Colonic
Diverticular Diseases
Intraabdominal Infections
Gastrointestinal Diseases
Digestive System Diseases
Diverticulosis, Colonic
Colonic Diseases
Intestinal Diseases