Back to resultsSymptomatic Treatment of Acute Uncomplicated Diverticulitis
Primary Purpose
Diverticulitis
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Ibuprofen
Paracetamol
Sponsored by
About this trial
This is an interventional treatment trial for Diverticulitis
Eligibility 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
Sites / Locations
- Helsinki University Central Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Symptomatic treatment
Arm Description
Outcomes
Primary Outcome Measures
Complications of diverticulitis
Incidence of complications of diverticulitis (abscess, free perforation, need for surgery)
Secondary Outcome Measures
Length of hospital stay (days)
Rate of re-admissions
Number patients re-admitted to hospital
Recurrence of diverticulitis
Number of recurrent diverticulitis within follow-up
Mortality
Number of patients deceased
Need for elective sigmoid resection
Number of patients that have undergone elective sigmoid resection
Need for emergency surgery for diverticulitis on another admission
Number of patients requiring emergency surgery for diverticulitis on another admission
Commencement of antimicrobial drug
Number of patients that have received antimicrobial drugs
Late complication of diverticulitis
Number of patients who develop late complications of diverticulitis e.g. fistula, stricture
Stoma rate
Number of patients who receive a stoma
Full Information
NCT ID
NCT02219698
First Posted
August 11, 2014
Last Updated
July 30, 2015
Sponsor
Helsinki University Central Hospital
Collaborators
Vatsatautien tutkimussäätiö - foundation, Mary and Georg Ehrnroot's foundation, Finnish Surgical society, Martti I. Turunen Foundation, Governmental competitive funds (EVO)
1. Study Identification
Unique Protocol Identification Number
NCT02219698
Brief Title
Symptomatic Treatment of Acute Uncomplicated Diverticulitis
Official Title
Symptomatic Treatment of Acute Uncomplicated Diverticulitis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital
Collaborators
Vatsatautien tutkimussäätiö - foundation, Mary and Georg Ehrnroot's foundation, Finnish Surgical society, Martti I. Turunen Foundation, Governmental competitive funds (EVO)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diverticulitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
158 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Symptomatic treatment
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Intervention Type
Drug
Intervention Name(s)
Paracetamol
Primary Outcome Measure Information:
Title
Complications of diverticulitis
Description
Incidence of complications of diverticulitis (abscess, free perforation, need for surgery)
Time Frame
30 days from allocation
Secondary Outcome Measure Information:
Title
Length of hospital stay (days)
Time Frame
At the end of the hospital stay, an expected average of 2 days
Title
Rate of re-admissions
Description
Number patients re-admitted to hospital
Time Frame
30 days from discharge
Title
Recurrence of diverticulitis
Description
Number of recurrent diverticulitis within follow-up
Time Frame
10 years
Title
Mortality
Description
Number of patients deceased
Time Frame
30 days from allocation
Title
Need for elective sigmoid resection
Description
Number of patients that have undergone elective sigmoid resection
Time Frame
10 years
Title
Need for emergency surgery for diverticulitis on another admission
Description
Number of patients requiring emergency surgery for diverticulitis on another admission
Time Frame
10 years
Title
Commencement of antimicrobial drug
Description
Number of patients that have received antimicrobial drugs
Time Frame
For the duration of hospital stay, an expected average of 2 days
Title
Late complication of diverticulitis
Description
Number of patients who develop late complications of diverticulitis e.g. fistula, stricture
Time Frame
10 years
Title
Stoma rate
Description
Number of patients who receive a stoma
Time Frame
10 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Helsinki University Central Hospital
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
12. IPD Sharing Statement
Citations:
PubMed Identifier
27145310
Citation
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.
Results Reference
derived
Learn more about this trial
Symptomatic Treatment of Acute Uncomplicated Diverticulitis
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