Hospitalization or Ambulatory Treatment of Acute Diverticulitis

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01081054

Acronym

01DIVER

Enrollment

132

Registered

2010-03-05

Start date

2009-09-30

Completion date

2012-06-30

Last updated

2012-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diverticulitis

Keywords

Diverticulitis, Not complicated diverticulitis

Brief summary

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.

Interventions

OTHERAmbulatory versus hospitalisation

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Treatment failure	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

Measure	Time frame	Description
Recurrence, quality of life, costs	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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026