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

Completed

• Conditions: Colonic Diverticulitis

• Registration Number: NCT01515150
• Lead Sponsor: Uppsala University

Brief 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.

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 Timeline

• Study First Submitted: 2012-01-18
• Study First Submitted QC: 2012-01-20
• Study First Posted: 2012-01-23
• Study Start: 2012-02
• Primary Completion: 2013-12
• Study Completion: 2014-08
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-23
• Last Update Posted: 2015-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 161

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of admission and complications among participant within three months follow-up.	Three months

Secondary Outcome Measures

Name	Time	Method
To evaluate reason of hospital admission, late complications, need of bowel rest and costs	Three months

Trial Locations

Locations (1)

Colorectal unit, department of surgery Västmanland Hospital Västerås; 🇸🇪 Västerås, Västmanland, Sweden