NCT02219698

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
158

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 11, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 19, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Last Updated

July 31, 2015

Status Verified

July 1, 2015

Enrollment Period

1 year

First QC Date

August 11, 2014

Last Update Submit

July 30, 2015

Conditions

Diverticulitis

Outcome Measures

Primary Outcomes (1)

  • Complications of diverticulitis

    Incidence of complications of diverticulitis (abscess, free perforation, need for surgery)

    30 days from allocation

Secondary Outcomes (9)

  • Length of hospital stay (days)

    At the end of the hospital stay, an expected average of 2 days

  • Rate of re-admissions

    30 days from discharge

  • Recurrence of diverticulitis

    10 years

  • Mortality

    30 days from allocation

  • Need for elective sigmoid resection

    10 years

  • +4 more secondary outcomes

Study Arms (1)

Symptomatic treatment

EXPERIMENTAL
Drug: IbuprofenDrug: Paracetamol

Interventions

IbuprofenDRUG
Symptomatic treatment
ParacetamolDRUG
Symptomatic treatment

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Computed tomography-diagnosed acute uncomplicated\* diverticulitis
  • No abscess, fistula, obstruction and distant intra- or retroperitoneal air. Pericolic air allowed.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helsinki University Central Hospital

Helsinki, 00029, Finland

Location

Related Publications (1)

  • 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.

    PMID: 27145310DERIVED

MeSH Terms

Conditions

Diverticulitis

Interventions

IbuprofenAcetaminophen

Condition Hierarchy (Ancestors)

Diverticular DiseasesGastroenteritisGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsAcetanilidesAnilidesAmidesAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Ph.D.

Study Record Dates

First Submitted

August 11, 2014

First Posted

August 19, 2014

Study Start

July 1, 2014

Primary Completion

July 1, 2015

Last Updated

July 31, 2015

Record last verified: 2015-07

Locations

FI(1)