Symptomatic Treatment of Acute Uncomplicated Diverticulitis

NCT ID: NCT02219698

Last Updated: 2015-07-31

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

Clinical Phase

NA

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Brief Summary

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The purpose of this study is to determine the safety and efficacy of symptomatic treatment (i.e. without antimicrobial drugs) of acute uncomplicated diverticulitis.

Detailed Description

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Conditions

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Diverticulitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Symptomatic treatment

Group Type EXPERIMENTAL

Ibuprofen

Intervention Type DRUG

Paracetamol

Intervention Type DRUG

Interventions

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Ibuprofen

Intervention Type DRUG

Paracetamol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Computed tomography-diagnosed acute uncomplicated\* diverticulitis

* No abscess, fistula, obstruction and distant intra- or retroperitoneal air. Pericolic air allowed.

Exclusion Criteria

* Already commenced antimicrobial medication
* Immunosuppression (e.g. diabetes, corticosteroid medication, immunosuppressive medication, chemotherapy, chronic liver disease)
* Suspicion of generalized peritonitis
* Organ dysfunction
* Another infection requiring antimicrobial medication
* Pregnancy
* Age \< 18 years or \> 90 years
* Missing written consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vatsatautien tutkimussäätiö - foundation

UNKNOWN

Sponsor Role collaborator

Mary and Georg Ehrnroot's foundation

UNKNOWN

Sponsor Role collaborator

Finnish Surgical society

UNKNOWN

Sponsor Role collaborator

Martti I. Turunen Foundation

UNKNOWN

Sponsor Role collaborator

Governmental competitive funds (EVO)

UNKNOWN

Sponsor Role collaborator

Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ville Sallinen

M.D., Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Helsinki University Central Hospital

Helsinki, , Finland

Site Status

Countries

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Finland

References

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Mali JP, Mentula PJ, Leppaniemi AK, Sallinen VJ. Symptomatic Treatment for Uncomplicated Acute Diverticulitis: A Prospective Cohort Study. Dis Colon Rectum. 2016 Jun;59(6):529-34. doi: 10.1097/DCR.0000000000000579.

Reference Type DERIVED
PMID: 27145310 (View on PubMed)

Other Identifiers

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HUS-Dnro122-2014

Identifier Type: -

Identifier Source: org_study_id