Outpatient Treatment of Uncomplicated Diverticulitis With Either Antibiotic or Nonantibiotic Treatment

NCT ID: NCT03146091

Last Updated: 2022-08-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-20
• Study Completion Date: 2020-12-30

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.

Conditions

Uncomplicated Diverticular Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Outpatient nonantibiotic treatment

Group Type: EXPERIMENTAL

Nonantibiotic treatment of uncomplicated diverticulitis

Intervention Type: 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 antibiotic treatment

Group Type: ACTIVE_COMPARATOR

Antibiotic treatment of uncomplicated diverticulitis

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jewish General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dr. Marylise Boutros

Colorectal Surgery Attending Staff, Assistant Professor of Surgery at McGill University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Jewish General Hospital

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

CODIM-MBM-17-020

Identifier Type: -

Identifier Source: org_study_id