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Symptomatic Treatment of Acute Uncomplicated Diverticulitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02219698
Recruitment Status : Completed
First Posted : August 19, 2014
Last Update Posted : July 31, 2015
Sponsor:
Collaborators:
Vatsatautien tutkimussäätiö - foundation
Mary and Georg Ehrnroot's foundation
Finnish Surgical society
Martti I. Turunen Foundation
Governmental competitive funds (EVO)
Information provided by (Responsible Party):
Ville Sallinen, Helsinki University Central Hospital

Tracking Information
First Submitted Date  ICMJE August 11, 2014
First Posted Date  ICMJE August 19, 2014
Last Update Posted Date July 31, 2015
Study Start Date  ICMJE July 2014
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 18, 2014)
Complications of diverticulitis [ Time Frame: 30 days from allocation ]
Incidence of complications of diverticulitis (abscess, free perforation, need for surgery)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2014)
  • Length of hospital stay (days) [ Time Frame: At the end of the hospital stay, an expected average of 2 days ]
  • Rate of re-admissions [ Time Frame: 30 days from discharge ]
    Number patients re-admitted to hospital
  • Recurrence of diverticulitis [ Time Frame: 10 years ]
    Number of recurrent diverticulitis within follow-up
  • Mortality [ Time Frame: 30 days from allocation ]
    Number of patients deceased
  • Need for elective sigmoid resection [ Time Frame: 10 years ]
    Number of patients that have undergone elective sigmoid resection
  • Need for emergency surgery for diverticulitis on another admission [ Time Frame: 10 years ]
    Number of patients requiring emergency surgery for diverticulitis on another admission
  • Commencement of antimicrobial drug [ Time Frame: For the duration of hospital stay, an expected average of 2 days ]
    Number of patients that have received antimicrobial drugs
  • Late complication of diverticulitis [ Time Frame: 10 years ]
    Number of patients who develop late complications of diverticulitis e.g. fistula, stricture
  • Stoma rate [ Time Frame: 10 years ]
    Number of patients who receive a stoma
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Symptomatic Treatment of Acute Uncomplicated Diverticulitis
Official Title  ICMJE Symptomatic Treatment of Acute Uncomplicated Diverticulitis
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diverticulitis
Intervention  ICMJE
  • Drug: Ibuprofen
  • Drug: Paracetamol
Study Arms  ICMJE Experimental: Symptomatic treatment
Interventions:
  • Drug: Ibuprofen
  • Drug: Paracetamol
Publications * Mali JP, Mentula PJ, Leppäniemi 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: August 18, 2014)
158
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02219698
Other Study ID Numbers  ICMJE HUS-Dnro122-2014
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ville Sallinen, Helsinki University Central Hospital
Study Sponsor  ICMJE Helsinki University Central Hospital
Collaborators  ICMJE
  • Vatsatautien tutkimussäätiö - foundation
  • Mary and Georg Ehrnroot's foundation
  • Finnish Surgical society
  • Martti I. Turunen Foundation
  • Governmental competitive funds (EVO)
Investigators  ICMJE Not Provided
PRS Account Helsinki University Central Hospital
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP