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

ISRCTN	ISRCTN42685776
DOI	https://doi.org/10.1186/ISRCTN42685776
Protocol serial number	N/A
Sponsor	Wexford General Hospital (Ireland)
Funder	Wexford General Hospital, Department of Surgery (Ireland)

Submission date: 24/03/2008
Registration date: 11/04/2008
Last edited: 11/04/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Paul Ridgway
Scientific

Department of Surgical Oncology
Room 3-130
Princess Margaret Hospital
610 University Ave
Toronto
M5G 2M9
Canada

Study information

Primary study design	Interventional
Study design	Multi-centre randomised controlled trial.
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Acute uncomplicated diverticulitis is a disease where outpouchings or blisters (termed Diverticulae) of the large bowel become inflamed resulting in pain and tenderness in the lower abdomen. Acute uncomplicated diverticulitis is currently treated with antibiotics although whether the antibiotics should be given through the veins or via the mouth is not known. Answering this question may allow treatment of the condition as an outpatient in the future. Diverticulosis affects 5% of western society by the fifth decade, its prevalence increasing to over 50% in the ninth. As less than a quarter of acute admissions necessitate surgery, medical therapy remains the mainstay of management in the majority of cases. There are no prospective data to guide the identification of a specific cohort which may be managed with an oral antibiotic regimen, nor the efficacy of a specific antibiotic regimen. The authors hypothesise that an oral antibiotic and fluid regimen is equally effective as intravenous antibiotics and 'bowel rest' in acute uncomplicated diverticulitis.
Ethics approval(s)	Approved by the Waterford Regional Ethics Board in 2002.
Health condition(s) or problem(s) studied	Acute uncomplicated diverticulitis
Intervention	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 arm: Oral ciprofloxacin (500 mg BID) and metranidazole (400 mg TID) without complete bowel rest. Duration of the interventions was equivalent to the length of stay, with a maximal antibiotic duration decided by the attending physician, typically 7-10 days.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Ciprofloxacin and metranidazole
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	31/05/2004

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	All
Target sample size at registration	76
Key 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
Key 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
Date of first enrolment	01/12/2002
Date of final enrolment	31/05/2004

Locations

Countries of recruitment

Canada
Ireland

Study participating centre

Department of Surgical Oncology

Toronto
M5G 2M9
Canada

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan