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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

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.

Condition or disease Intervention/treatment Phase
Diverticulitis Drug: Ibuprofen Drug: Paracetamol Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 158 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Symptomatic Treatment of Acute Uncomplicated Diverticulitis
Study Start Date : July 2014
Actual Primary Completion Date : July 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Ibuprofen

Arm Intervention/treatment
Experimental: Symptomatic treatment Drug: Ibuprofen
Drug: Paracetamol



Primary Outcome Measures :
  1. Complications of diverticulitis [ Time Frame: 30 days from allocation ]
    Incidence of complications of diverticulitis (abscess, free perforation, need for surgery)


Secondary Outcome Measures :
  1. Length of hospital stay (days) [ Time Frame: At the end of the hospital stay, an expected average of 2 days ]
  2. Rate of re-admissions [ Time Frame: 30 days from discharge ]
    Number patients re-admitted to hospital

  3. Recurrence of diverticulitis [ Time Frame: 10 years ]
    Number of recurrent diverticulitis within follow-up

  4. Mortality [ Time Frame: 30 days from allocation ]
    Number of patients deceased

  5. Need for elective sigmoid resection [ Time Frame: 10 years ]
    Number of patients that have undergone elective sigmoid resection

  6. Need for emergency surgery for diverticulitis on another admission [ Time Frame: 10 years ]
    Number of patients requiring emergency surgery for diverticulitis on another admission

  7. 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

  8. Late complication of diverticulitis [ Time Frame: 10 years ]
    Number of patients who develop late complications of diverticulitis e.g. fistula, stricture

  9. Stoma rate [ Time Frame: 10 years ]
    Number of patients who receive a stoma



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02219698


Locations
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Finland
Helsinki University Central Hospital
Helsinki, Finland, 00029
Sponsors and Collaborators
Helsinki University Central Hospital
Vatsatautien tutkimussäätiö - foundation
Mary and Georg Ehrnroot's foundation
Finnish Surgical society
Martti I. Turunen Foundation
Governmental competitive funds (EVO)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ville Sallinen, M.D., Ph.D., Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT02219698    
Other Study ID Numbers: HUS-Dnro122-2014
First Posted: August 19, 2014    Key Record Dates
Last Update Posted: July 31, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Diverticulitis
Diverticular Diseases
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action