Hospitalization or Ambulatory Treatment of Acute Diverticulitis

The purpose of 01DIVER is to evaluate efficacy and safety of a home treatment protocol for non complicated diverticulitis compared with management in the hospital. The hypothesis is that a ambulatory treatment with oral antibiotic and progressive introduction of diet is not inferior to the conservative management in hospital in patients with acute not complicated sigmoid diverticulitis, shown by contrast enhanced CT scan. Patients are prospectively randomized to conservative antibiotic treatment either to ambulatory or to hospital treatment.

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Key information

Conditions

Diverticulitis Digestive System Diseases Diverticular Diseases Gastroenteritis Gastrointestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Universitari de la Vall d´Hebron, Barcelona, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age older than 18 years
Diagnosis of mild diverticulitis by abdominal computerized tomography
Signed informed consent

Exclusion criteria

Severe diverticulitis
Informed consent not signed
Suspicion of colon cancer
Pneumoperitoneum
Intolerance for oral feeding
Antibiotics for diverticulitis in the last month
Immunosuppression
Pregnancy or lactation
Severe (decompensated) other illness
Psychological or social problems

Treatment and study plan

Ambulatory versus hospitalisation

Other

Patients are treated with the same antibiotic agent, the difference between the two arms is endovenous treatment for hospitalized patients for the first days till oral feeding. The ambulatory group starts directly with orally administered antibiotic treatment.

Primary outcomes

Treatment failure

Time frame: 30 days

Failure of the conservative treatment within 30 days after randomization which consists in one or more of the mentioned signs: persistent or increasing pain, treatment resistant fever, intestinal oclusion, necesity to drain a new intra-abdominal abscess, indication for surgery, mortality.

Secondary outcomes

Recurrence, quality of life, costs

Time frame: 30 days

Recurrence of diverticulitis within 30 days; quality of life and patient satisfaction is asessed comparing management with and without admittance to the hospital and costs are calculated for the treatment in both regimens.

Sponsors and collaborators

Lead sponsor

Hospital Universitari de Bellvitge

Other

Registry information

Official study title

Randomized Trial Comparing Two Treatment Strategies for Acute Diverticulitis. Hospitalization or Ambulatory Antibiotic Treatment

Acronym: 01DIVER

Important dates

Study start: 2009
Primary completion: 2012
Study completion: 2012
First posted: Mar 5, 2010
Registry last updated: Jun 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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