Outpatient Treatment of Uncomplicated Diverticulitis With Either Antibiotic or Nonantibiotic Treatment

Uncomplicated Diverticular Disease Clinical Trial

— MUD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03146091
• Other study ID #: CODIM-MBM-17-020
• Status: Completed
• Phase: N/A
• Start date: May 20, 2017
• Est. completion date: December 30, 2020

Study information

• Verified date: August 2022
• Source: Jewish General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.ht ml 19-20.

Related Conditions & MeSH terms

• Diverticulitis
• Diverticulum
• Uncomplicated Diverticular Disease

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Jewish General Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Jewish General Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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