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Study Title and Description

One-day versus four-day antibiotic treatment for acute right colonic uncomplicated diverticulitis: A randomized clinical trial.



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 One-day versus four-day antibiotic treatment for acute right colonic uncomplicated diverticulitis: A randomized clinical trial.
Author Park JH., Park HC., Lee BH.
Country Department of Surgery, Hallym University College of Medicine, Anyang, Korea.
Year 2019
Numbers Pubmed ID: 31290747

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: Cephalosporin + Metronidazole 1-day group
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2 Antibiotics: Cephalosporin + Metronidazole 4-day group
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Design Details
Question... Follow Up Answer Follow-up Answer
Specific KQ KQ 2b: Antibiotics (acute)
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Study Design RCT
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Country ... Specify Other ... Korea
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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 2011
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2014
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Inclusion criteria aged >18 years who were admitted to the emergency room or outpatient clinics of our university medical center with suspected right colonic uncomplicated diverticulitis; then patients with right colonic uncomplicated diverticulitis confirmed by CT were included in the study
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Exclusion criteria an abscess >3 cm in diameter, Hinchey II diseases or worse, ongoing antibiotic therapy from other hospital, pregnancy, or cephalosporin allergy
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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 Inflamed diverticulum, phlegmon formation (Hinchey Ia), and small (≤3 cm) pericolic abscess formation (partial Hinchey Ib) were considered to be consistent with the diagnosis of CT-based uncomplicated diverticulitis
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Note/Comment about Design (or overall study)
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Baseline Characteristics
Question Antibiotics: Cephalosporin + Metronidazole Antibiotics: Cephalosporin + Metronidazole Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant race/ethnicity characteristics Male 54.0 Male 55.1
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Participant Age - Continuous data (in years) Mean 42.0 Mean 40.2
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SD 11.1 SD 11.2
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Participant Age - Categorical data No data entered.
Participants with Un/Complicated Diverticulitis Uncomplicated diverticulitis 100 Uncomplicated diverticulitis 100
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Specific Complications of Diverticulitis No data entered.
Number of Prior Episodes of Diverticulitis (categorical) 0 100 0 100
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History of (Prior) Complicated Diverticulitis No 100 No 100
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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
P-Value
Outcome: Hospitalization (or re-hospitalization) for diverticulitis (avoidance)      Population: All Participants Between-Arm Comparisons
Time Point Measure Antibiotics: Cephalosporin + Metronidazole Antibiotics: Cephalosporin + Metronidazole Comparison Measure Antibiotics: Cephalosporin + Metronidazole vs. Antibiotics: Cephalosporin + Metronidazole


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N Analyzed 87 89 0.502
Counts 8 11
Percentage 9.2 12.4
P-Value
Outcome: Recurrence of diverticulitis      Population: All Participants Between-Arm Comparisons
Time Point Measure Antibiotics: Cephalosporin + Metronidazole Antibiotics: Cephalosporin + Metronidazole Comparison Measure Antibiotics: Cephalosporin + Metronidazole vs. Antibiotics: Cephalosporin + Metronidazole


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N Analyzed 87 89 0.762
Counts 9 8
Percentage 10.3 9.0
P-Value
Outcome: Treatment failure      Population: All Participants Between-Arm Comparisons
Time Point Measure Antibiotics: Cephalosporin + Metronidazole Antibiotics: Cephalosporin + Metronidazole Comparison Measure Antibiotics: Cephalosporin + Metronidazole vs. Antibiotics: Cephalosporin + Metronidazole


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N Analyzed 87 89 0.493
Counts 15 19
Percentage 17.2 21.3


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 Low
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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. Low
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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. Low
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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.
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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.