Outpatient Treatment of Uncomplicated Diverticulitis With Either Antibiotic or Nonantibiotic Treatment (MUD)

Study on Outpatient Treatment of Uncomplicated Diverticulitis With Either Antibiotic or Nonantibiotic Treatment: a Randomized Pilot Trial

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.

Study Overview

• Status: Completed
• Conditions: Uncomplicated Diverticular Disease
• Intervention / Treatment: Other: Nonantibiotic treatment of uncomplicated diverticulitis; Other: Antibiotic treatment of uncomplicated diverticulitis

Detailed Description

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. It is designed as a pilot non-inferiority blinded randomized controlled trial. The estimated length of this pilot trial is 1 year. The target population is capable adults of who have a CT-diagnosed episode of uncomplicated diverticulitis who present to the Jewish General Hospital Emergency room.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
      • Jewish General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age ≥ 18 and < 90 years old
2. Capable of giving informed consent
3. Lower abdominal pain and/or tenderness
4. Confirmed affection of left colon, including descending and sigmoid colon
5. 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:

1. 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.
2. Suspicion of colorectal cancer on CT scan
3. Immunosuppression (including but not exclusively insulin-dependent diabetes mellitus, chronic liver disease, ongoing chemotherapy, chronic renal failure with hemodialysis, corticosteroid and immunosuppressive medication)
4. Pregnancy and breastfeeding
5. Any comorbid infection requiring
6. High fever (≥ 38.5 ºC)
7. Significant leukocytosis (> 15 g/dL)
8. Abdominal pain worsening in the emergency, impeding ambulation and/or eating
9. Evidence of generalized peritonitis on physical exam
10. Intolerance to oral intake and/or persistent vomiting
11. Marked abdominal distension and/or signs of ileus on CT scan
12. Noncompliance/unreliability for return visits/lack of support system
13. Failed outpatient treatment not previously included in study within last 30 days
14. Cognitive, social or psychiatric impairment
15. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Outpatient nonantibiotic treatment	Other: Nonantibiotic treatment of uncomplicated diverticulitis; Patients randomized to this arm will be treated without antibiotics in the outpatient setting. Pain will be managed with appropriate analgesia as per protocol.
Active Comparator: Outpatient antibiotic treatment	Other: Antibiotic treatment of uncomplicated diverticulitis; Patients randomized to this arm will be treated with antibiotics in the outpatient setting. Pain will be managed with appropriate analgesia as per protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment failure	Treatment failure is defined as persistence, increase or recurrence of abdominal pain and/or fever, inflammatory bowel obstruction, need for radiological abscess drainage or immediate surgery due to complicated diverticulitis, need for hospital admission, and mortality during the first 60 days after discharge.	1 year

Collaborators and Investigators

• Sponsor: Jewish General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2017
• Primary Completion (Actual): December 30, 2019
• Study Completion (Actual): December 30, 2020

Study Registration Dates

• First Submitted: April 18, 2017
• First Submitted That Met QC Criteria: May 5, 2017
• First Posted (Actual): May 9, 2017

Study Record Updates

• Last Update Posted (Actual): August 18, 2022
• Last Update Submitted That Met QC Criteria: August 17, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Antibiotics
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Pathological Conditions, Anatomical; Diverticulitis; Diverticulum; Diverticular Diseases; Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: CODIM-MBM-17-020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No