Condition category
Digestive System
Date applied
24/03/2008
Date assigned
11/04/2008
Last edited
11/04/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Paul Ridgway

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

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

Approved by the Waterford Regional Ethics Board in 2002.

Study design

Multi-centre randomised controlled trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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 names

Ciprofloxacin and metranidazole

Primary outcome measures

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 outcome measures

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

Overall trial start date

01/12/2002

Overall trial end date

31/05/2004

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

76

Participant 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

Recruitment start date

01/12/2002

Recruitment end date

31/05/2004

Locations

Countries of recruitment

Ireland

Trial participating centre

Department of Surgical Oncology
Toronto
M5G 2M9
Canada

Sponsor information

Organisation

Wexford General Hospital (Ireland)

Sponsor details

Department of Surgery
-
Wexford
Ireland

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Wexford General Hospital, Department of Surgery (Ireland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes