Outpatient Treatment of Uncomplicated Diverticulitis With Either Antibiotic or Nonantibiotic Trea… (NCT03146091) | Clinical Trial Compass
CompletedNot Applicable
Outpatient Treatment of Uncomplicated Diverticulitis With Either Antibiotic or Nonantibiotic Treatment
Canada33 participantsStarted 2017-05-20
Plain-language summary
Uncomplicated sigmoid diverticulitis is a common disease in Western countries. Traditional management includes inpatient administration of either oral or intravenous antibiotics with resumption of oral intake as symptoms improve. Recent literature has however questioned both inpatient and antibiotic treatment. Indeed, both inpatient and antibiotic treatment are associated with non-negligible risks to patients. The aim of this trial is to assess the feasibility of a randomized controlled trial designed to determine whether nonantibiotic treatment of uncomplicated diverticulitis is safe in the outpatient setting.
Who can participate
Age range18 Years – 90 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18 and \< 90 years old
✓. Capable of giving informed consent
✓. Lower abdominal pain and/or tenderness
✓. Confirmed affection of left colon, including descending and sigmoid colon
✓. Confirmed episode of acute uncomplicated diverticulitis on computed tomography (CT) scan defined as wall edema with or without fat stranding. Limited pericolic air with bubbles less than 5 mm in size, and less than 5cm from the colon wall, will be included as uncomplicated diverticulitis. Scan must be performed prior to enrollment and assessment for illegibility. The initial scan is not a study-specific procedure.
Exclusion criteria
✕. CT scan shows complicated diverticulitis as defined by the presence of intraperitoneal free perforation (i.e. intraperitoneal contrast extravasation if intra-rectal contrast given, free air under diaphragms, disseminated intraperitoneal air), abscess, obstruction, fistulisation, and phlegmon.
✕. Suspicion of colorectal cancer on CT scan
✕
What they're measuring
1
Participants' retention rate as assessed by the number of participants retained in the study from screening to the end of follow-up.