Diverticulitis
Conditions
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.
Interventions
DRUGIbuprofen
DRUGParacetamol
Sponsors
Vatsatautien tutkimussäätiö - foundation
Mary and Georg Ehrnroot's foundation
Finnish Surgical society
Martti I. Turunen Foundation
Governmental competitive funds (EVO)
Helsinki University Central Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complications of diverticulitis | 30 days from allocation | Incidence of complications of diverticulitis (abscess, free perforation, need for surgery) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of re-admissions | 30 days from discharge | Number patients re-admitted to hospital |
| Recurrence of diverticulitis | 10 years | Number of recurrent diverticulitis within follow-up |
| Mortality | 30 days from allocation | Number of patients deceased |
| Need for elective sigmoid resection | 10 years | Number of patients that have undergone elective sigmoid resection |
| Length of hospital stay (days) | At the end of the hospital stay, an expected average of 2 days | — |
| Commencement of antimicrobial drug | For the duration of hospital stay, an expected average of 2 days | Number of patients that have received antimicrobial drugs |
| Late complication of diverticulitis | 10 years | Number of patients who develop late complications of diverticulitis e.g. fistula, stricture |
| Stoma rate | 10 years | Number of patients who receive a stoma |
| Need for emergency surgery for diverticulitis on another admission | 10 years | Number of patients requiring emergency surgery for diverticulitis on another admission |
Countries
Finland
Outcome results
None listed