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

This study is currently recruiting participants.
Verified March 2013 by Uppsala University
Sponsor:
Information provided by (Responsible Party):
Uppsala University
ClinicalTrials.gov Identifier:
NCT01515150
First received: January 18, 2012
Last updated: March 28, 2013
Last verified: March 2013
History of Changes
  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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 160
Study Start Date: February 2012
Estimated Study Completion Date: May 2014
Estimated 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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01515150

Contacts
Contact: Abbas Chabok, MD, PhD 0046 21 173000 abbas.chabok@ltv.se
Contact: Maziar Hosseinali Khani, MD, PhD 0046 21 173000 maziar.hosseinalikhani@ltv.se

Locations
Sweden
Colorectal unit, department of surgery Västmanland Hospital Västerås Recruiting
Västerås, Västmanland, Sweden, 72189
Contact: Abbas Chabok, MD, PhD     0046 21 173000     abbas.chabok@ltv.se    
Sub-Investigator: Maziar Hosseinali Khani, MD, Phd            
Sponsors and Collaborators
Uppsala University
Investigators
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: March 28, 2013
Health Authority: Sweden: Regional Ethical Review Board

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

Additional relevant MeSH terms:
Diverticulitis
Diverticulitis, Colonic
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Diverticulosis, Colonic
 Colonic Diseases
Intestinal Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013