Outpatient Treatment of Uncomplicated Diverticulitis With Either Antibiotic or Nonantibiotic Treatment

NCT03146091 | Completed

• 1 other identifier: CODIM-MBM-17-020
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Uncomplicated Diverticular Disease

Keywords

Antibiotics

Outcome Measures

Primary Outcomes (1)

• Participants' retention rate as assessed by the number of participants retained in the study from screening to the end of follow-up.

  The primary outcome pertains to the feasibility of a non-inferiority randomized controlled trial. The study group's main concern is that accrual will be impeded by the important change in clinical management that nonantibiotic treatment of uncomplicated diverticulitis requires. Also, the study group is concerned that patients may be lost to follow-up. For these reasons, the primary outcome is the retention rate of patients from screening to the end of follow-up. The rate will be calculated according to (1) the proportion of participants screened but not randomized, and (2) the proportion of participants lost to follow-up.

  1 year

Secondary Outcomes (1)

• Treatment failure

  1 year

Study Arms (2)

Outpatient nonantibiotic treatment

EXPERIMENTAL

Other: Nonantibiotic treatment of uncomplicated diverticulitis

Outpatient antibiotic treatment

ACTIVE COMPARATOR

Other: Antibiotic treatment of uncomplicated diverticulitis

Interventions

Nonantibiotic treatment of uncomplicated diverticulitis OTHER

Patients randomized to this arm will be treated without antibiotics in the outpatient setting. Pain will be managed with appropriate analgesia as per protocol.

Outpatient nonantibiotic treatment

Antibiotic treatment of uncomplicated diverticulitis OTHER

Patients randomized to this arm will be treated with antibiotics in the outpatient setting. Pain will be managed with appropriate analgesia as per protocol.

Outpatient antibiotic treatment

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Immunosuppression (including but not exclusively insulin-dependent diabetes mellitus, chronic liver disease, ongoing chemotherapy, chronic renal failure with hemodialysis, corticosteroid and immunosuppressive medication)
• Pregnancy and breastfeeding
• Any comorbid infection requiring
• High fever (≥ 38.5 ºC)
• Significant leukocytosis (\> 15 g/dL)
• Abdominal pain worsening in the emergency, impeding ambulation and/or eating
• Evidence of generalized peritonitis on physical exam
• Intolerance to oral intake and/or persistent vomiting
• Marked abdominal distension and/or signs of ileus on CT scan
• Noncompliance/unreliability for return visits/lack of support system
• Failed outpatient treatment not previously included in study within last 30 days
• Cognitive, social or psychiatric impairment
• For patients aged 65 years or older, a Charlson Comorbidity Score ≥ 5 as calculated on the following website: https://www.thecalculator.co/health/Charlson-Comorbidity-Index-(CCI)-Calculator-765.html 19-20.

Sponsors & Collaborators

• Jewish General Hospital: lead

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Colorectal Surgery Attending Staff, Assistant Professor of Surgery at McGill University

Study Record Dates

• First Submitted: April 18, 2017
• First Posted: May 9, 2017
• Study Start: May 20, 2017
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2020
• Last Updated: August 18, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)