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Study Title and Description

Prospective randomized clinical trial of uncomplicated right-sided colonic diverticulitis: antibiotics versus no antibiotics.



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 Prospective randomized clinical trial of uncomplicated right-sided colonic diverticulitis: antibiotics versus no antibiotics.
Author Kim JY., Park SG., Kang HJ., Lim YA., Pak KH., Yoo T., Cho WT., Shin DW., Kim JW.
Country Department of Surgery, Dongtan Sacred Heart Hospital, Hallym University College of Medicine, 40, Sukwoo-Dong, Hwaseong-Si, Gyeonggi-Do, 445-170, Republic of Korea.
Year 2019
Numbers Pubmed ID: 31267222

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 Placebo admitted, administered IV fluids, and given bowel rest for at least 3 days (and up to 5 days)
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2 Antibiotics: Cephalosporin + Metronidazole
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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 ... 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 NCT02314013
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Start and end years of the Study 2014
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2018
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Inclusion criteria (1) age 18–80 years; (2) right-sided colonic diverticulitis (cecum, ascending colon, or proximal transverse colon); and (3) uncomplicated diverticulitis (grade Ia)
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Exclusion criteria (1) age < 18 or > 80 years; (2) distaltransverse, left-sided, or sigmoid colonic diverticulitis; (3) complicated colonic diverticulitis (grades Ib, II, III, or IV); (4) sepsis; (5) systemic inflammatory response syndrome (SIRS); (6) immunocompromised patients (taking corticosteroid or immunosuppressive drugs, transplantation, or chronic renal failure with hemodialysis); (7) allergy to quinolone antibiotics; (8) pregnant or lactating patients; (9) American Society of Anesthesiologists (ASA) score > 3; (10) social, psychiatric, or cognitive impairment
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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 intravenous (IV) contrast–enhanced computed tomography (CT) was performed to confirm the diagnosis. Uncomplicated diverticulitis is defined as grade Ia and complicated diverticulitis includes grades Ib, II, III, and IV.
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Note/Comment about Design (or overall study)
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Baseline Characteristics
Question Placebo Antibiotics: Cephalosporin + Metronidazole Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant race/ethnicity characteristics Male 57.8 Male 65.6
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Participant Age - Continuous data (in years) Mean 38.9 Mean 37.9
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SD 9.5 SD 8.4
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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) Not reported Not reported
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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
Outcome: Treatment failure      Population: All Participants Between-Arm Comparisons
Time Point Measure Placebo Antibiotics: Cephalosporin + Metronidazole Comparison Measure Placebo vs. Antibiotics: Cephalosporin + Metronidazole


Enter a numeric value or title (required) years

N Analyzed 64 61 0.619
Counts 3 1
Percentage 4.7 1.6
P-Value
Outcome: Recurrence of diverticulitis      Population: All Participants Between-Arm Comparisons
Time Point Measure Placebo Antibiotics: Cephalosporin + Metronidazole Comparison Measure Placebo vs. Antibiotics: Cephalosporin + Metronidazole


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N Analyzed 64 61 0.690
Counts 5 6
Percentage 7.8 9.8
P-Value
Outcome: Length of hospital (or intensive care unit) stay      Population: All Participants Between-Arm Comparisons
Time Point Measure Placebo Antibiotics: Cephalosporin + Metronidazole Comparison Measure ERROR vs. ERROR


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N Analyzed 64 61 0.985
Mean 5.3 5.3
SD 0.8 0.8


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
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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
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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
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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.