The Out-patient, Non Antibiotic Management of Patients With Acute Uncomplicated Colonic Diverticulitis

Colonic Diverticulitis Clinical Trial

— P-VOD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01515150
• Other study ID #: P-VOD
• Status: Completed
• Phase: N/A
• First received: January 18, 2012
• Last updated: January 23, 2015
• Start date: February 2012
• Est. completion date: August 2014

Study information

• Verified date: January 2015
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: August 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colonic Diverticulitis
• Diverticulitis
• Diverticulitis, Colonic

Locations

Country	Name	City	State
Sweden	Colorectal unit, department of surgery Västmanland Hospital Västerås	Västerås	Västmanland

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of admission and complications among participant within three months follow-up.		Three months	Yes
Secondary	To evaluate reason of hospital admission, late complications, need of bowel rest and costs		Three months	Yes