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Completed

NCT Number: NCT01515150

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

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.

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Key information

Conditions

Colonic Diverticulitis Colonic Diseases Digestive System Diseases Diverticular Diseases Diverticulitis Diverticulitis, Colonic Diverticulosis, Colonic Gastroenteritis Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Colorectal unit, department of surgery Västmanland Hospital Västerås

Västerås, Västmanland County, 72189, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of admission and complications among participant within three months follow-up.

    Time frame: Three months

Secondary outcomes

  1. To evaluate reason of hospital admission, late complications, need of bowel rest and costs

    Time frame: Three months

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Registry information

Official study title

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

Acronym: P-VOD

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Jan 23, 2012
Registry last updated
Jan 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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