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Completed

NCT Number: NCT02219698

Symptomatic Treatment of Acute Uncomplicated Diverticulitis

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

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Key information

Conditions

Diverticulitis Digestive System Diseases Diverticular Diseases Gastroenteritis Gastrointestinal Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helsinki University Central Hospital

Helsinki, 00029, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ibuprofen

Drug

Paracetamol

Drug

Primary outcomes

  1. Complications of diverticulitis

    Time frame: 30 days from allocation

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Collaborators

  • Finnish Surgical society
  • Governmental competitive funds (EVO)
  • Martti I. Turunen Foundation
  • Mary and Georg Ehrnroot's foundation
  • Vatsatautien tutkimussäätiö - foundation

Registry information

Important dates

Study start
2014
Primary completion
2015
First posted
Aug 19, 2014
Registry last updated
Jul 31, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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