The Out-patient, Non Antibiotic Management of Patients With Acute Uncomplicated Colonic Diverticulitis (P-VOD)
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Purpose
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 |
|---|
|
Colonic Diverticulitis |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Management of Patients With Uncomplicated Diverticulitis as Out-patient and Without Antibiotics |
- Number of admission and complications among participant within three months follow-up. [ Time Frame: Three months ] [ Designated as safety issue: Yes ]
- To evaluate reason of hospital admission, late complications, need of bowel rest and costs [ Time Frame: Three months ] [ Designated as safety issue: Yes ]
| Enrollment: | 161 |
| Study Start Date: | February 2012 |
| Study Completion Date: | August 2014 |
| Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Out-patients in diverticulitis
All patient with acute uncomplicated diverticulitis how accept participation in the study will be enrolled in the study.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 95 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: 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 |
More Information
No publications provided
| Responsible Party: | Uppsala University |
| ClinicalTrials.gov Identifier: | NCT01515150 History of Changes |
| Other Study ID Numbers: | P-VOD |
| Study First Received: | January 18, 2012 |
| Last Updated: | January 23, 2015 |
| Health Authority: | Sweden: Regional Ethical Review Board |
Keywords provided by Uppsala University:
|
diverticulitis Out-patient management Antibiotics |
Additional relevant MeSH terms:
|
Diverticulitis Diverticulitis, Colonic Colonic Diseases Digestive System Diseases Diverticulosis, Colonic |
Gastroenteritis Gastrointestinal Diseases Infection Intestinal Diseases Intraabdominal Infections |
ClinicalTrials.gov processed this record on March 03, 2015