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Study Title and Description

Randomized controlled trial of oral vs intravenous therapy for the clinically diagnosed acute uncomplicated diverticulitis.



Key Questions Addressed
2 KEY QUESTION 2 KQ 2: What are the benefits and harms of various treatment options for the treatment of acute diverticulitis? KQ 2a. For patients with acute uncomplicated diverticulitis, what are the effectiveness and harms of hospitalization versus outpatient management of the acute episode? • Do the effects and harms vary by patient characteristics, presentation or course of illness, or other factors? KQ 2b. For patients with acute uncomplicated or complicated diverticulitis, what are the effects, comparative effects, and harms of antibiotics? • Do the effects and harms vary between patients with complicated or uncomplicated diverticulitis? • Do the (comparative) effects and harms vary by route of administration of antibiotics, type of antibiotic, and duration of course of antibiotics? • Do the (comparative) effects and harms vary by patient characteristics, presentation or course of illness, or other factors? KQ 2c. For patients with acute complicated diverticulitis, what are the effects and harms of interventional radiology procedures compared with conservative management? • Do the effects and harms vary by patient characteristics, presentation or course of illness, or other factors?
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Primary Publication Information
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TitleData
Title Randomized controlled trial of oral vs intravenous therapy for the clinically diagnosed acute uncomplicated diverticulitis.
Author Ridgway PF., Latif A., Shabbir J., Ofriokuma F., Hurley MJ., Evoy D., O'Mahony JB., Mealy K.
Country Department of Surgery, Wexford General Hospital, Ireland. p.ridgway@imperial.ac.uk
Year 2009
Numbers Pubmed ID: 19016815

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Extraction Form for KQs 2 and 4
Arms
Number Title Description Comments
1 Antibiotics: Ciprofloxacin + Metronidazole Oral
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2 Antibiotics: Ciprofloxacin + Metronidazole IV
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Design Details
Question... Follow Up Answer Follow-up Answer
Specific KQ KQ 2b: Antibiotics (acute)
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KQ 2b: Antibiotics (acute)
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Study Design RCT
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RCT
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Country ... Specify Other ... Ireland
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Funder Not reported (or unclear)
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Study name
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Associated articles
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ClinicalTrials.gov identifier
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Start and end years of the Study 2002
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2004
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Inclusion criteria Acute uncomplicated diverticulitis. Hinchey type 1. Pyrexia and ⁄ or leucocytosis were desirable.
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Exclusion criteria Hinchey types III or IV
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Specific population? ... Population specified... ... Hinchey type I
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Was diverticulitis diagnosed with CT? Other imaging (eg, U/S, barium enema; not CT)
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If NRCS, what analytic method was used to account for differences between study arms?
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How was diverticulitis diagnosed Plain radiology and relevant blood investigation
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Baseline Characteristics
Question Antibiotics: Ciprofloxacin + Metronidazole Antibiotics: Ciprofloxacin + Metronidazole Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant race/ethnicity characteristics Male 39.02 Male 44.74
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Participant Age - Continuous data (in years) Median 68 Median 66
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Range 31-84 Range 41-86
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Participant Age - Categorical data No data entered.
Participants with Un/Complicated Diverticulitis No data entered.
Specific Complications of Diverticulitis No data entered.
Number of Prior Episodes of Diverticulitis (categorical) No data entered.
History of (Prior) Complicated Diverticulitis No data entered.
KQ 4: Time Since Last Episode of Diverticulitis No data entered.
Note/Comment about baseline characteristics No data entered.
Number of Prior Episodes of Diverticulitis (continuous) No data entered.



Results & Comparisons


Results Data
Outcome: Hospitalization (or re-hospitalization) for diverticulitis (avoidance)      Population: All Participants
Time Point Measure Antibiotics: Ciprofloxacin + Metronidazole Antibiotics: Ciprofloxacin + Metronidazole


30 days

N Analyzed 41 38
Counts 1 1
P-Value
Outcome: Length of hospital (or intensive care unit) stay      Population: All Participants Between-Arm Comparisons
Time Point Measure Antibiotics: Ciprofloxacin + Metronidazole Antibiotics: Ciprofloxacin + Metronidazole Comparison Measure Antibiotics: Ciprofloxacin + Metronidazole vs. Antibiotics: Ciprofloxacin + Metronidazole


Enter a numeric value or title (required) days

N Analyzed 41 38 0.12
Mean 5.5 6.6
SD
SE 0.3 0.67
P-Value
Outcome: Diverticulitis-related morbidities      Population: All Participants Between-Arm Comparisons
Time Point Measure Antibiotics: Ciprofloxacin + Metronidazole Antibiotics: Ciprofloxacin + Metronidazole Comparison Measure Antibiotics: Ciprofloxacin + Metronidazole vs. Antibiotics: Ciprofloxacin + Metronidazole


3 days

N Analyzed 41 38 0.79
Mean 1.26 1.20
SD
SE


Quality Dimensions
Dimension Value Notes Comments
Q14: Cochrane - Random sequence generation (selection bias): Selection bias (biased allocation to interventions) due to inadequate generation of a randomized sequence Low Randomization was accomplished by the sealed opaque envelope technique.
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Q15: Cochrane - Allocation concealment (selection bias): Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment Unclear Information regarding allocation concealment was not provided.
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Q16: Cochrane - Blinding of participants (performance bias): Performance bias due to knowledge of the allocated interventions by participants during the study Unclear Study does not mention if participants were blinded.
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Q17: Cochrane - Blinding of personnel/ care providers (performance bias): Performance bias due to knowledge of the allocated interventions by personnel/care providers during the study. High Physicians were not blinded.
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Q18: Cochrane - FOR OBJECTIVE OUTCOMES - Blinding of outcome assessor (detection bias): Detection bias due to knowledge of the allocated interventions by outcome assessors. No Physicians were not blinded.
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Q20: Cochrane - Incomplete outcome data (attrition bias): Attrition bias due to amount, nature or handling of incomplete outcome data Low Reasons for missing outcome data was balanced in numbers. The percentage of withdrawals/drop-outs did not exceed 20%.
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Q21: Cochrane - Selective Reporting (reporting bias): Reporting bias due to selective outcome reporting Low Study protocol is unavailable, but expected outcomes were reported.
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Q22: Cochrane - Other Bias: Bias due to problems not covered elsewhere in the table. If yes, describe them in the Notes. Low Study appears to be free of other sources of bias.
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Q1: ROBINS-I 1.1 Is there potential for confounding of the effect of intervention in this study?
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Q3: ROBINS-I 1.4. Did the authors use an appropriate analysis method that controlled for all the important confounding domains?
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Q4: ROBINS-I 1.5. If Y/PY to 1.4: Were confounding domains that were controlled for measured validly and reliably by the variables available in this study?
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Q5: ROBINS-I 1.6. Did the authors control for any post-intervention variables that could have been affected by the intervention?
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Q6: ROBINS-I - Risk of bias judgement for BIAS DUE TO CONFOUNDING
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Q7: ROBINS-I 2.1. Was selection of participants into the study (or into the analysis) based on participant characteristics observed after the start of intervention?
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Q8: ROBINS-I 2.2. If Y/PY to 2.1: Were the post-intervention variables that influenced selection likely to be associated with intervention?
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Q9: ROBINS-I 2.3 If Y/PY to 2.2: Were the post-intervention variables that influenced selection likely to be influenced by the outcome or a cause of the outcome?
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Q10: ROBINS-I 2.4. Do start of follow-up and start of intervention coincide for most participants?
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Q12: ROBINS-I 2.5. If Y/PY to 2.2 and 2.3, or N/PN to 2.4: Were adjustment techniques used that are likely to correct for the presence of selection biases?
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Q13: ROBINS-I - Risk of bias judgement for BIAS IN SELECTION OF PARTICIPANTS INTO THE STUDY
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Q2: Did the study divide the follow up time of each individual participant into the different interventions?
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Q11: Did the start and follow up calendar years coincide for most participants in the study?
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Q19: Cochrane - FOR SUBJECTIVE OUTCOMES - Blinding of outcome assessor (detection bias): Detection bias due to knowledge of the allocated interventions by outcome assessors. No Physicians were not blinded.
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Q23: NHLBI - Were eligibility/selection criteria for the study population prespecified and clearly described?
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Q24: NHLBI - Was the test/service/intervention clearly described and delivered consistently across the study population?
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Q25: NHLBI - Were the outcome measures prespecified, clearly defined, valid, reliable, and assessed consistently across all study participants?
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Quality Rating
No quality rating data was found.