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

Management of Patients With Uncomplicated Diverticulitis as Out-patient and Without Antibiotics

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.

Study Overview

• Status: Completed
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 161

Contacts and Locations

Study Locations

• Sweden
  • Västmanland
    • Västerås, Västmanland, Sweden, 72189
      • Colorectal unit, department of surgery Västmanland Hospital Västerås

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with CT- scan varified acute uncomplicated diverticulitis how are abel to underwent out-patients managment

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of admission and complications among participant within three months follow-up.	Three months

Secondary Outcome Measures

Outcome Measure	Time Frame
To evaluate reason of hospital admission, late complications, need of bowel rest and costs	Three months

Collaborators and Investigators

• Sponsor: Uppsala University
• Investigators: Study Chair: Mats Enlund, Ass. Prof, Centre of Clinical Research of Uppsala University, Västmanlands Hospital Västerås

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: January 18, 2012
• First Submitted That Met QC Criteria: January 20, 2012
• First Posted (Estimate): January 23, 2012

Study Record Updates

• Last Update Posted (Estimate): January 26, 2015
• Last Update Submitted That Met QC Criteria: January 23, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Antibiotics; diverticulitis; Out-patient management
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Diverticular Diseases; Diverticulosis, Colonic; Diverticulitis; Diverticulitis, Colonic
• Other Study ID Numbers: P-VOD