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

Primary Purpose

Uncomplicated Diverticular Disease

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Nonantibiotic treatment of uncomplicated diverticulitis
Antibiotic treatment of uncomplicated diverticulitis
Sponsored by
Jewish General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uncomplicated Diverticular Disease focused on measuring Antibiotics

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Jewish General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Outpatient nonantibiotic treatment

Outpatient antibiotic treatment

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 18, 2017
Last Updated
August 17, 2022
Sponsor
Jewish General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03146091
Brief Title
Outpatient Treatment of Uncomplicated Diverticulitis With Either Antibiotic or Nonantibiotic Treatment
Acronym
MUD
Official Title
Study on Outpatient Treatment of Uncomplicated Diverticulitis With Either Antibiotic or Nonantibiotic Treatment: a Randomized Pilot Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
May 20, 2017 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
December 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jewish General Hospital

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uncomplicated Diverticular Disease
Keywords
Antibiotics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Outpatient nonantibiotic treatment
Arm Type
Experimental
Arm Title
Outpatient antibiotic treatment
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Nonantibiotic treatment of uncomplicated diverticulitis
Intervention Description
Patients randomized to this arm will be treated without antibiotics in the outpatient setting. Pain will be managed with appropriate analgesia as per protocol.
Intervention Type
Other
Intervention Name(s)
Antibiotic treatment of uncomplicated diverticulitis
Intervention Description
Patients randomized to this arm will be treated with antibiotics in the outpatient setting. Pain will be managed with appropriate analgesia as per protocol.
Primary Outcome Measure Information:
Title
Participants' retention rate as assessed by the number of participants retained in the study from screening to the end of follow-up.
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Treatment failure
Description
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.
Time Frame
1 year

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: 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 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.
Facility Information:
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Outpatient Treatment of Uncomplicated Diverticulitis With Either Antibiotic or Nonantibiotic Treatment

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