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

Completed

Conditions: Acute uncomplicated diverticulitis
Digestive System
Diverticular disease of intestine

Registration Number: ISRCTN42685776

Lead Sponsor: Wexford General Hospital (Ireland)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 76

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Resolution of symptoms. Three surrogates were used: <br>1. Resolution of left iliac fossa tenderness, assessed by the Wexford tenderness score (a locally validated score), daily assessment while an in-patient<br>2. Length of stay <br>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 Outcome Measures

Name	Time	Method
The following were evaluated as potential surrogates for resolution: <br>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<br>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<br>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<br>4. Temperature charts, daily assessment while an in-patient