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
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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 |
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Colonic Diverticulitis |
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 |

Group/Cohort |
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Out-patients in diverticulitis
All patient with acute uncomplicated diverticulitis how accept participation in the study will be enrolled in the study.
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- Number of admission and complications among participant within three months follow-up. [ Time Frame: Three months ]
- To evaluate reason of hospital admission, late complications, need of bowel rest and costs [ Time Frame: Three months ]

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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 |
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

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
Sweden | |
Colorectal unit, department of surgery Västmanland Hospital Västerås | |
Västerås, Västmanland, Sweden, 72189 |
Study Chair: | Mats Enlund, Ass. Prof | Centre of Clinical Research of Uppsala University, Västmanlands Hospital Västerås |
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 |