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

NCT ID: NCT01515150

Last Updated: 2015-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

161 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-02-29

Study Completion Date

2014-08-31

Brief Summary

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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

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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.

Conditions

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Colonic Diverticulitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Out-patients in diverticulitis

All patient with acute uncomplicated diverticulitis how accept participation in the study will be enrolled in the study.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Uppsala University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mats Enlund, Ass. Prof

Role: STUDY_CHAIR

Centre of Clinical Research of Uppsala University, Västmanlands Hospital Västerås

Locations

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Colorectal unit, department of surgery Västmanland Hospital Västerås

Västerås, Västmanland County, Sweden

Site Status

Countries

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Sweden

Other Identifiers

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P-VOD

Identifier Type: -

Identifier Source: org_study_id

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