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Study Title and Description

Randomized clinical trial of antibiotics in 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 clinical trial of antibiotics in acute uncomplicated diverticulitis.
Author Chabok A., Påhlman L., Hjern F., Haapaniemi S., Smedh K.
Country Colorectal Unit, Department of Surgery, and Centre for Clinical Research Uppsala University, Västmanlands Hospital, Västerås, Sweden.
Year 2012
Numbers Pubmed ID: 22290281

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: Multiple (discretionary or undefined) IV combination of a second- or third- generation cephalosporin (cefuroxime or cefotaxime) and metronidazole, or with carbapenem antibiotics (ertapenem, meropenem or imipenem) or piperacillin – tazobactam. Orally administrated antibiotics such as ciprofloxacin or cefadroxil combined with metronidazole were initiated subsequently on the ward or at discharge.
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2 Placebo IV fluids only
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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 ... Sweden
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Funder Non-industry (fully)
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Study name AVOD
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Associated articles
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ClinicalTrials.gov identifier NCT01008488
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Start and end years of the Study 2003
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2009
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Inclusion criteria >=18 yo, acute lower abdominal pain with tenderness, fever, raised WBC or CRP, CT c/w diverticulitis
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Exclusion criteria CT or other evidence of complicated diverticulitis or other disease, immunosuppressive Tx, pregnancy, ongoing antibiotics
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Specific population? No (all comers)
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Was diverticulitis diagnosed with CT? 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
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Note/Comment about Design (or overall study) initial outcomes from an RCT, long term followup from a prospective cohort study
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Baseline Characteristics
Question Antibiotics: Multiple (discretionary or undefined) Placebo Antibiotics: Multiple (discretionary or undefined) Placebo Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant race/ethnicity characteristics Male 35 Male 36
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Participant Age - Continuous data (in years) Mean 57.4 Mean 57.1
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SD 12.8 SD 13.2
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Participant Age - Categorical data No data entered.
Participants with Un/Complicated Diverticulitis Complicated diverticulitis 0 Complicated diverticulitis 0 Complicated diverticulitis 0
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Uncomplicated diverticulitis 100 Uncomplicated diverticulitis 100 Uncomplicated diverticulitis 100
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Specific Complications of Diverticulitis 100 100
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Number of Prior Episodes of Diverticulitis (categorical) Other_1 (include definition in %) >=1 35.6 Other_1 (include definition in %) >=1 44.8
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History of (Prior) Complicated Diverticulitis Not reported Not reported
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KQ 4: Time Since Last Episode of Diverticulitis Not reported Not reported
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Note/Comment about baseline characteristics No data entered.
Number of Prior Episodes of Diverticulitis (continuous) Not reported Not reported
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Results & Comparisons


Results Data
P-Value P-Value
Outcome: Recurrence of diverticulitis      Population: All Participants Between-Arm Comparisons
Time Point Measure Antibiotics: Multiple (discretionary or undefined) Placebo Antibiotics: Multiple (discretionary or undefined) Placebo Comparison Measure Antibiotics: Multiple (discretionary or undefined) vs. Placebo


>=12 months

N Analyzed 292 290 0.881
Counts 46 47
Percentage 15.8 16.2


Median 11 years

N Analyzed 281 275 0.492
Counts 88 86
Percentage 31.3 31.3
P-Value
Outcome: Adverse event - any      Population: All Participants Between-Arm Comparisons
Time Point Measure Antibiotics: Multiple (discretionary or undefined) Placebo Antibiotics: Multiple (discretionary or undefined) Placebo Comparison Measure Antibiotics: Multiple (discretionary or undefined) vs. Placebo


30 days

N Analyzed 314 309 0.302
Counts 3 6
Percentage 1 1.9
P-Value P-Value
Outcome: Diverticulitis-related morbidities      Population: All Participants Between-Arm Comparisons
Time Point Measure Antibiotics: Multiple (discretionary or undefined) Placebo Antibiotics: Multiple (discretionary or undefined) Placebo Comparison Measure Antibiotics: Multiple (discretionary or undefined) vs. Placebo


30 days

N Analyzed 314 309 0.985
Counts 3 3
Percentage 1 1


Median 11 years

N Analyzed 281 275 0.737
Counts 14 12
Percentage 5.0 4.4
Outcome: Surgery for diverticulitis, including colostomy (avoidance)      Population: All Participants
Time Point Measure Antibiotics: Multiple (discretionary or undefined) Placebo Antibiotics: Multiple (discretionary or undefined) Placebo


5 days

N Analyzed 314 309
Counts 3 1
Percentage 1 0.3


12 months

N Analyzed 292 290
Counts 2 6
Percentage 0.6 1.9


Median 11 years

N Analyzed 281 275
Counts 20 17
Percentage 7.1 6.2
Outcome: Adverse event - leading to discontinuation      Population: All Participants
Time Point Measure Antibiotics: Multiple (discretionary or undefined) Placebo Antibiotics: Multiple (discretionary or undefined) Placebo


~7 days

N Analyzed 314 309
Counts 3 10
Percentage 1 discontinued antibiotics due to allergic side effects 3.2 started antibiotics due to increase in CRP, fever, abd. pain
P-Value
Outcome: Diverticulitis-related morbidities      Population: All Participants Between-Arm Comparisons
Time Point Measure Antibiotics: Multiple (discretionary or undefined) Placebo Antibiotics: Multiple (discretionary or undefined) Placebo Comparison Measure Antibiotics: Multiple (discretionary or undefined) vs. Placebo


30 days

N Analyzed 314 309 0.080
Counts 0 3
Percentage 0 1
P-Value P-Value
Outcome: Mortality - All-cause (non-AE)      Population: All Participants Between-Arm Comparisons
Time Point Measure Antibiotics: Multiple (discretionary or undefined) Placebo Antibiotics: Multiple (discretionary or undefined) Placebo Comparison Measure Antibiotics: Multiple (discretionary or undefined) vs. Placebo


12 months

N Analyzed 314 309
Counts 1 0
Percentage 0.3 0


Median 11 years

N Analyzed 281 275 0.823
Counts 28 26
Percentage
P-Value P-Value
Outcome: Diverticulitis-related morbidities      Population: All Participants Between-Arm Comparisons
Time Point Measure Antibiotics: Multiple (discretionary or undefined) Placebo Antibiotics: Multiple (discretionary or undefined) Placebo Comparison Measure Antibiotics: Multiple (discretionary or undefined) vs. Placebo


12 months

N Analyzed 292 290 NS
Counts
Percentage 53.3 53.3


Median 11 years

N Analyzed 281 275
Counts
Percentage 62.1 52.1
P-Value P-Value
Outcome: Diverticulitis-related morbidities      Population: All Participants Between-Arm Comparisons
Time Point Measure Antibiotics: Multiple (discretionary or undefined) Placebo Antibiotics: Multiple (discretionary or undefined) Placebo Comparison Measure Antibiotics: Multiple (discretionary or undefined) vs. Placebo


12 months

N Analyzed 292 290 NS
Counts
Percentage 27.2 27.5


Median 11 years

N Analyzed 281 275
Counts
Percentage 25.8 29.3
P-Value P-Value
Outcome: Diverticulitis-related morbidities      Population: All Participants Between-Arm Comparisons
Time Point Measure Antibiotics: Multiple (discretionary or undefined) Placebo Antibiotics: Multiple (discretionary or undefined) Placebo Comparison Measure Antibiotics: Multiple (discretionary or undefined) vs. Placebo


12 months

N Analyzed 292 290 NS
Counts
Percentage 13.4 14.0


Median 11 years

N Analyzed 281 275
Counts
Percentage 10.1 14.4
P-Value P-Value
Outcome: Diverticulitis-related morbidities      Population: All Participants Between-Arm Comparisons
Time Point Measure Antibiotics: Multiple (discretionary or undefined) Placebo Antibiotics: Multiple (discretionary or undefined) Placebo Comparison Measure Antibiotics: Multiple (discretionary or undefined) vs. Placebo


12 months

N Analyzed 292 290 NS
Counts
Percentage 4.2 4.1


Median 11 years

N Analyzed 281 275
Counts
Percentage 0.9 4.1
P-Value P-Value
Outcome: Diverticulitis-related morbidities      Population: All Participants Between-Arm Comparisons
Time Point Measure Antibiotics: Multiple (discretionary or undefined) Placebo Antibiotics: Multiple (discretionary or undefined) Placebo Comparison Measure Antibiotics: Multiple (discretionary or undefined) vs. Placebo


12 months

N Analyzed 292 290 NS
Counts
Percentage 1.7 1.4


Median 11 years

N Analyzed 281 275
Counts
Percentage 0.9 0
P-Value P-Value
Outcome: Diverticulitis-related morbidities      Population: All Participants Between-Arm Comparisons
Time Point Measure Antibiotics: Multiple (discretionary or undefined) Placebo Antibiotics: Multiple (discretionary or undefined) Placebo Comparison Measure Antibiotics: Multiple (discretionary or undefined) vs. Placebo


12 months

N Analyzed 292 290 NS
Counts
Percentage 70.4 65.4


Median 11 years

N Analyzed 281 275
Counts
Percentage 63.0 54.4
P-Value P-Value
Outcome: Diverticulitis-related morbidities      Population: All Participants Between-Arm Comparisons
Time Point Measure Antibiotics: Multiple (discretionary or undefined) Placebo Antibiotics: Multiple (discretionary or undefined) Placebo Comparison Measure Antibiotics: Multiple (discretionary or undefined) vs. Placebo


12 months

N Analyzed 292 290 NS
Counts
Percentage 4.5 8.1


Median 11 years

N Analyzed 281 275
Counts
Percentage 0.7 5.7
P-Value P-Value
Outcome: Diverticulitis-related morbidities      Population: All Participants Between-Arm Comparisons
Time Point Measure Antibiotics: Multiple (discretionary or undefined) Placebo Antibiotics: Multiple (discretionary or undefined) Placebo Comparison Measure Antibiotics: Multiple (discretionary or undefined) vs. Placebo


12 months

N Analyzed 292 290 NS
Counts
Percentage 4.5 6.4


Median 11 years

N Analyzed 281 275
Counts
Percentage 4.7 8.6
P-Value P-Value
Outcome: Diverticulitis-related morbidities      Population: All Participants Between-Arm Comparisons
Time Point Measure Antibiotics: Multiple (discretionary or undefined) Placebo Antibiotics: Multiple (discretionary or undefined) Placebo Comparison Measure Antibiotics: Multiple (discretionary or undefined) vs. Placebo


12 months

N Analyzed 292 290 NS
Counts
Percentage 19.2 20.6


Median 11 years

N Analyzed 281 275
Counts
Percentage 28.6 28.6
Outcome: Quality of life      Population: All Participants
Time Point Measure Antibiotics: Multiple (discretionary or undefined) Placebo Antibiotics: Multiple (discretionary or undefined) Placebo


Median 11 years

N Analyzed 142 163
Counts
Percentage 86.4 83.5
Outcome: Quality of life      Population: All Participants
Time Point Measure Antibiotics: Multiple (discretionary or undefined) Placebo Antibiotics: Multiple (discretionary or undefined) Placebo


Median 11 years

N Analyzed 142 163
Counts
Percentage 13.6 16.6
P-Value Note
Outcome: Quality of life      Population: All Participants Between-Arm Comparisons
Time Point Measure Antibiotics: Multiple (discretionary or undefined) Placebo Antibiotics: Multiple (discretionary or undefined) Placebo Comparison Measure ERROR vs. ERROR


Median 11 years

N Analyzed 142 163 0.340
Counts across levels
Percentage 0 0
Outcome: Quality of life      Population: All Participants
Time Point Measure Antibiotics: Multiple (discretionary or undefined) Placebo Antibiotics: Multiple (discretionary or undefined) Placebo


Median 11 years

N Analyzed 142 163
Counts
Percentage 96.5 96.9
Outcome: Quality of life      Population: All Participants
Time Point Measure Antibiotics: Multiple (discretionary or undefined) Placebo Antibiotics: Multiple (discretionary or undefined) Placebo


Median 11 years

N Analyzed 142 163
Counts
Percentage 3 2.5
P-Value Note
Outcome: Quality of life      Population: All Participants Between-Arm Comparisons
Time Point Measure Antibiotics: Multiple (discretionary or undefined) Placebo Antibiotics: Multiple (discretionary or undefined) Placebo Comparison Measure Antibiotics: Multiple (discretionary or undefined) vs. Placebo


Median 11 years

N Analyzed 142 163 0.838
Counts across levels
Percentage 0 .06
Outcome: Quality of life      Population: All Participants
Time Point Measure Antibiotics: Multiple (discretionary or undefined) Placebo Antibiotics: Multiple (discretionary or undefined) Placebo


Median 11 years

N Analyzed 142 163
Counts
Percentage 80.3 78.1
Outcome: Quality of life      Population: All Participants
Time Point Measure Antibiotics: Multiple (discretionary or undefined) Placebo Antibiotics: Multiple (discretionary or undefined) Placebo


Median 11 years

N Analyzed 142 163
Counts
Percentage 17.6 20
P-Value Note
Outcome: Quality of life      Population: All Participants Between-Arm Comparisons
Time Point Measure Antibiotics: Multiple (discretionary or undefined) Placebo Antibiotics: Multiple (discretionary or undefined) Placebo Comparison Measure Antibiotics: Multiple (discretionary or undefined) vs. Placebo


Median 11 years

N Analyzed 142 163 0.721
Counts across levels
Percentage 2.1 1.9
Outcome: Quality of life      Population: All Participants
Time Point Measure Antibiotics: Multiple (discretionary or undefined) Placebo Antibiotics: Multiple (discretionary or undefined) Placebo


Median 11 years

N Analyzed 142 163
Counts
Percentage 49.3 48.4
Outcome: Quality of life      Population: All Participants
Time Point Measure Antibiotics: Multiple (discretionary or undefined) Placebo Antibiotics: Multiple (discretionary or undefined) Placebo


Median 11 years

N Analyzed 142 163
Counts
Percentage 49.6 48.4
P-Value Note
Outcome: Quality of life      Population: All Participants Between-Arm Comparisons
Time Point Measure Antibiotics: Multiple (discretionary or undefined) Placebo Antibiotics: Multiple (discretionary or undefined) Placebo Comparison Measure Antibiotics: Multiple (discretionary or undefined) vs. Placebo


Median 11 years

N Analyzed 142 163 0.772
Counts across levels
Percentage 2.1 3.1
Outcome: Quality of life      Population: All Participants
Time Point Measure Antibiotics: Multiple (discretionary or undefined) Placebo Antibiotics: Multiple (discretionary or undefined) Placebo


Median 11 years

N Analyzed 142 163
Counts
Percentage 76.8 72.8
Outcome: Quality of life      Population: All Participants
Time Point Measure Antibiotics: Multiple (discretionary or undefined) Placebo Antibiotics: Multiple (discretionary or undefined) Placebo


Median 11 years

N Analyzed 142 163
Counts
Percentage 22.5 25.9
P-Value Note
Outcome: Quality of life      Population: All Participants Between-Arm Comparisons
Time Point Measure Antibiotics: Multiple (discretionary or undefined) Placebo Antibiotics: Multiple (discretionary or undefined) Placebo Comparison Measure Antibiotics: Multiple (discretionary or undefined) vs. Placebo


Median 11 years

N Analyzed 142 163 0.354
Counts across levels
Percentage 0.7 1.3
Outcome: Colorectal cancer      Population: All Participants
Time Point Measure Antibiotics: Multiple (discretionary or undefined) Placebo Antibiotics: Multiple (discretionary or undefined) Placebo


6-8 weeks

N Analyzed 314 309
Counts 0 0
P-Value
Outcome: Length of hospital (or intensive care unit) stay      Population: All Participants Between-Arm Comparisons
Time Point Measure Antibiotics: Multiple (discretionary or undefined) Placebo Antibiotics: Multiple (discretionary or undefined) Placebo Comparison Measure Antibiotics: Multiple (discretionary or undefined) vs. Placebo


follow up N/A

N Analyzed 314 309 0.717
Mean 2.9 2.9
SD 1.9 1.6
Median 3 3
Max 0 0
Min 25 25
P-Value P-Value P-Value P-Value P-Value P-Value P-Value P-Value
Outcome: Diverticulitis-related morbidities      Population: All Participants Between-Arm Comparisons
Time Point Measure Antibiotics: Multiple (discretionary or undefined) Placebo Antibiotics: Multiple (discretionary or undefined) Placebo Comparison Measure Antibiotics: Multiple (discretionary or undefined) vs. Placebo


0 days

N Analyzed 314 309
Mean 6.0 6.0
SD
Median
Max
Min


1 days

N Analyzed 314 309
Mean 4.1 4.1
SD
Median
Max
Min


2 days

N Analyzed 314 309
Mean 2.0 2.0
SD
Median
Max
Min


3 days

N Analyzed 314 309
Mean 1.0 1.6
SD
Median
Max
Min


4 days

N Analyzed 314 309
Mean 1.0 1.7
SD
Median
Max
Min


5 days

N Analyzed 314 309
Mean 0.9 1.4
SD
Median
Max
Min


1-5 days

N Analyzed 314 309 0.253, 0.886 Reported only across all time points
Mean
SD
Median
Max
Min


Median 11 years

N Analyzed 281 275 0.475
Mean 7.8 7.6
SD
Median
Max
Min
P-Value P-Value P-Value P-Value P-Value P-Value P-Value
Outcome: Diverticulitis-related morbidities      Population: All Participants Between-Arm Comparisons
Time Point Measure Antibiotics: Multiple (discretionary or undefined) Placebo Antibiotics: Multiple (discretionary or undefined) Placebo Comparison Measure Antibiotics: Multiple (discretionary or undefined) vs. Placebo


0 days

N Analyzed 314 309
Mean 38.1 38.2
SD
Median
Max
Min


1 days

N Analyzed 314 309
Mean 37.2 37.2
SD
Median
Max
Min


2 days

N Analyzed 314 309
Mean 37.0 37.0
SD
Median
Max
Min


3 days

N Analyzed 314 309
Mean 36.9 36.8
SD
Median
Max
Min


4 days

N Analyzed 314 309
Mean 37.0 37.0
SD
Median
Max
Min


5 days

N Analyzed 314 309
Mean 37.0 37.0
SD
Median
Max
Min


1-5 days

N Analyzed of net difference 0.343
Mean
SD
Median
Max
Min
P-Value P-Value P-Value P-Value P-Value P-Value P-Value Mean Difference (Net)
Outcome: Diverticulitis-related morbidities      Population: All Participants Between-Arm Comparisons
Time Point Measure Antibiotics: Multiple (discretionary or undefined) Placebo Antibiotics: Multiple (discretionary or undefined) Placebo Comparison Measure Antibiotics: Multiple (discretionary or undefined) vs. Placebo


0 days

N Analyzed 314 309
Mean 2.63 2.56
SD
Median
Max
Min


1 days

N Analyzed 314 309
Mean 2.36 2.36
SD
Median
Max
Min


2 days

N Analyzed 314 309
Mean 1.65 1.79
SD
Median
Max
Min


3 days

N Analyzed 314 309
Mean 1.31 1.38
SD
Median
Max
Min


4 days

N Analyzed 314 309
Mean 1.11 1.11
SD
Median
Max
Min


5 days

N Analyzed 314 309
Mean 1.18 1.23
SD
Median
Max
Min


1-5 days

N Analyzed 0.041
Mean 0.2
SD
Median
Max
Min
P-Value
Outcome: Quality of life      Population: All Participants Between-Arm Comparisons
Time Point Measure Antibiotics: Multiple (discretionary or undefined) Placebo Antibiotics: Multiple (discretionary or undefined) Placebo Comparison Measure Antibiotics: Multiple (discretionary or undefined) vs. Placebo


Median 11 years

N Analyzed 281 275 0.469
Mean 0.834 0.819
SD
Median
Max
Min


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
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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 Low
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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 High Open trial
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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 Open trial
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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. High Open trial
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Q20: Cochrane - Incomplete outcome data (attrition bias): Attrition bias due to amount, nature or handling of incomplete outcome data Low
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Q21: Cochrane - Selective Reporting (reporting bias): Reporting bias due to selective outcome reporting Low
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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
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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. High Open trial
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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.