Randomised controlled trial of oral versus intravenous therapy for clinically diagnosed acute uncomplicated diverticulitis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN42685776

Enrollment

Registered

2008-04-11

Start date

2002-12-01

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Acute uncomplicated diverticulitis Digestive System Diverticular disease of intestine

Interventions

Two intervention arms: Intravenous arm: Intravenous ciprofloxacin (400 mg twice a day [BID]) and metranidazole (500 mg three times a day [TID]) with bowel rest for at least the first 24 hours. Oral

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients presented with a clinical syndrome of left iliac fossa pain and local tenderness (Hinchey type I and II) 2. Both men and women

Exclusion criteria

Exclusion criteria: 1. Those with complicated Diverticulitis (Hinchey III and IV) 2. Those in Septic Shock 3. Allergies to antibiotics used in the trial 4. Hepatic or Renal insufficiency 5. Diagnosis is not clear 6. Co-morbid conditions necessitating prolonged hospital stay 7. Pregnant women or women who are breast feeding

Design outcomes

Primary

Measure	Time frame
Resolution of symptoms. Three surrogates were used: 1. Resolution of left iliac fossa tenderness, assessed by the Wexford tenderness score (a locally validated score), daily assessment while an in-patient 2. Length of stay 3. Failure of oral therapy (requiring supplemental parenteral therapy). Follow-up: Until confirmatory/ refuting lower gastrointestinal (GI) series (endoscopic or contrast). Where such a test was not performed, follow-up to last out-patient appointment	—

Measure

Time frame

Resolution of symptoms. Three surrogates were used: 1. Resolution of left iliac fossa tenderness, assessed by the Wexford tenderness score (a locally validated score), daily assessment while an in-patient 2. Length of stay 3. Failure of oral therapy (requiring supplemental parenteral therapy). Follow-up: Until confirmatory/ refuting lower gastrointestinal (GI) series (endoscopic or contrast). Where such a test was not performed, follow-up to last out-patient appointment

—

Secondary

Measure	Time frame
The following were evaluated as potential surrogates for resolution: 1. Serial erythrocyte sedimentation rate (ESR). Follow-up: Until confirmatory/ refuting lower GI series (endoscopic or contrast). Where such a test was not performed, follow-up to last out-patient appointment 2. C reactive protein (CRP). Follow-up: Until confirmatory/ refuting lower GI series (endoscopic or contrast). Where such a test was not performed, follow-up to last out-patient appointment 3. White cell count (WCC). Follow-up: Until confirmatory/ refuting lower GI series (endoscopic or contrast). Where such a test was not performed, follow-up to last out-patient appointment 4. Temperature charts, daily assessment while an in-patient	—

Measure

Time frame

The following were evaluated as potential surrogates for resolution: 1. Serial erythrocyte sedimentation rate (ESR). Follow-up: Until confirmatory/ refuting lower GI series (endoscopic or contrast). Where such a test was not performed, follow-up to last out-patient appointment 2. C reactive protein (CRP). Follow-up: Until confirmatory/ refuting lower GI series (endoscopic or contrast). Where such a test was not performed, follow-up to last out-patient appointment 3. White cell count (WCC). Follow-up: Until confirmatory/ refuting lower GI series (endoscopic or contrast). Where such a test was not performed, follow-up to last out-patient appointment 4. Temperature charts, daily assessment while an in-patient

—

Countries

Ireland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026