Hospitalization or Ambulatory Treatment of Acute Diverticulitis

NCT01081054 | Completed Phase 4

• 2 other identifiers: 01DIVER2008-008452-17
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 5

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.

Conditions

Diverticulitis

Keywords

Diverticulitis; Not complicated diverticulitis

Outcome Measures

Primary Outcomes (1)

• Treatment failure

  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.

  30 days

Secondary Outcomes (1)

• Recurrence, quality of life, costs

  30 days

Study Arms (2)

Ambulatory Treatment

OTHER

Patients are treated ambulatory with oral antibiotic for 10 days; for the first five days these patients are contacted by telephone daily to progress oral intake.

Other: Ambulatory versus hospitalisation

Hospital treatment

ACTIVE COMPARATOR

Patients are hospitalized and treated with antibiotic, for the first days by endovenous antibiotic and with diet progression orally.

Other: Ambulatory versus hospitalisation

Interventions

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.

Ambulatory Treatment; Hospital treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitari de Bellvitge: lead

Study Sites (5)

Hospital Universitari de la Vall d´Hebron

Barcelona, Barcelona, 08035, Spain

Location

Hospital Universitari Bellvitge, Colorectal Unit

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital Universitari de Girona Doctor Josep Trueta

Girona, Girona, 17007, Spain

Location

Hospital Virgen del Camino

Pamplona, Navarre, 31008, Spain

Location

Hospital Clinico Universitario De Valencia

Valencia, Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Diverticulitis

Condition Hierarchy (Ancestors)

Diverticular Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Sebastiano Biondo, MD, PhD

  Hospital Universitari de Bellvitge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: S. Biondo, MD, PhD, Colorectal Unit, Department of Surgery

Study Record Dates

• First Submitted: March 4, 2010
• First Posted: March 5, 2010
• Study Start: September 1, 2009
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: June 12, 2012

Record last verified: 2012-06

Locations

ES (5)