The Out-patient, Non Antibiotic Management of Patients With Acute Uncomplicated Colonic Diverticulitis (P-VOD)
This study has been completed.
Sponsor:
Uppsala University
Information provided by (Responsible Party):
Uppsala University
ClinicalTrials.gov Identifier:
NCT01515150
First received: January 18, 2012
Last updated: January 23, 2015
Last verified: January 2015
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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 |
Resource links provided by NLM:
Further study details as provided by Uppsala University:
Primary Outcome Measures:
- Number of admission and complications among participant within three months follow-up. [ Time Frame: Three months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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 (Adult, Senior) |
| Genders Eligible for Study: | Both |
| 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
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01515150
Please refer to this study by its ClinicalTrials.gov identifier: 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
| 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 Intraabdominal Infections Infection Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Diverticulosis, Colonic Colonic Diseases Intestinal Diseases |
ClinicalTrials.gov processed this record on September 23, 2016