NCT03146091

Outpatient Treatment of Uncomplicated Diverticulitis With Either Antibiotic or Nonantibiotic Treatment

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Jewish General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2017-05-20
• Primary completion: 2019-12-30
• Completion: 2020-12-30
• First posted: 2017-05-09
• Last updated: 2022-08-18

Locations

1 site across 1 country: Canada