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Study Title and Description

Antibiotics alone instead of percutaneous drainage as initial treatment of large diverticular abscess.



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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4 KEY QUESTION 4 KQ 4: What are the effects, comparative effects, and harms of pharmacological interventions (e.g., mesalamine), non-pharmacological interventions (e.g., medical nutrition therapy), and elective surgery to prevent recurrent diverticulitis? • Do the (comparative) effects and harms vary by patient characteristics, course of illness, or other factors?
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Primary Publication Information
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TitleData
Title Antibiotics alone instead of percutaneous drainage as initial treatment of large diverticular abscess.
Author XXX - EXCLUDED - Elagili F., Stocchi L., Ozuner G., Kiran RP.
Country Department of Colorectal Surgery, Digestive Disease Institute, Cleveland Clinic, 9500 Euclid Avenue, A-30, Cleveland, OH, 44195, USA, elagilf@ccf.org.
Year 2015
Numbers Pubmed ID: 25417122

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 IR: Percutaneous drainage
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Design Details
Question... Follow Up Answer Follow-up Answer
Specific KQ KQ 2c: Interventional radiology (acute)
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KQ 2c: Interventional radiology (acute)
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KQ 2c: Interventional radiology (acute)
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Study Design Other single group study (for harms only)
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Country USA
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USA
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USA
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Funder Not reported (or unclear)
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Study name Cleveland Clinic Digestive Disease Institute 1994-2012
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Associated articles 25172167
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ClinicalTrials.gov identifier
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Start and end years of the Study 1994
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2012
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Inclusion criteria abscess of >=3 cm diameter on CT associated with sigmoid diverticulitis
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Exclusion criteria requirement of urgent surgery
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if not an RCT, what was the directionality? Retrospective
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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 Both diagnosis and diameter measurement of the diverticular abscess were based on computed tomography (CT) imaging.
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Note/Comment about Design (or overall study)
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Baseline Characteristics
Question IR: Percutaneous drainage Total Comments
AnswerFollow-up AnswerFollow-up
Participant race/ethnicity characteristics Male 54
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Participant Age - Continuous data (in years) Median 56.5
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Range 25-85
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Participant Age - Categorical data No data entered.
Participants with Un/Complicated Diverticulitis Complicated diverticulitis 100
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Specific Complications of Diverticulitis diameter of at least 3 cm
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100
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Number of Prior Episodes of Diverticulitis (categorical) 0 39
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>=2 61
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History of (Prior) Complicated Diverticulitis Not reported
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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: Mortality - All-cause (non-AE)      Population: All Participants
Time Point Measure IR: Percutaneous drainage


4-6 weeks

N Analyzed 114
Counts 3
Percentage 2.6
Outcome: Diverticulitis-related morbidities      Population: All Participants
Time Point Measure IR: Percutaneous drainage


4-6 weeks

N Analyzed 114
Counts 51
Percentage 45
Outcome: Diverticulitis-related morbidities      Population: All Participants
Time Point Measure IR: Percutaneous drainage


4-6 weeks

N Analyzed 114
Counts 16
Percentage 14
Outcome: Morbidity      Population: All Participants
Time Point Measure IR: Percutaneous drainage


4-6 weeks

N Analyzed 114
Counts 42
Percentage 37
Outcome: Failure of treatment      Population: All Participants
Time Point Measure IR: Percutaneous drainage


48 hours

N Analyzed 114
Counts 21
Percentage 18.4
Outcome: Success of treatment      Population: All Participants
Time Point Measure IR: Percutaneous drainage


48 hours

N Analyzed 114
Counts 92
Percentage 80.7


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
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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
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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
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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.
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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.
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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.
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Q23: NHLBI - Were eligibility/selection criteria for the study population prespecified and clearly described? Yes
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Q24: NHLBI - Was the test/service/intervention clearly described and delivered consistently across the study population? Yes
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Q25: NHLBI - Were the outcome measures prespecified, clearly defined, valid, reliable, and assessed consistently across all study participants? Yes
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Quality Rating
No quality rating data was found.