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Study Title and Description

Prospective randomized clinical trial assessing the efficacy of a short course of intravenously administered amoxicillin plus clavulanic acid followed by oral antibiotic in patients with uncomplicated acute 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 Prospective randomized clinical trial assessing the efficacy of a short course of intravenously administered amoxicillin plus clavulanic acid followed by oral antibiotic in patients with uncomplicated acute diverticulitis.
Author Ribas Y., Bombardó J., Aguilar F., Jovell E., Alcantara-Moral M., Campillo F., Lleonart X., Serra-Aracil X.
Country Department of Surgery, Consorci Sanitari de Terrassa, Carretera de Torrebonica s/n, Terrassa, Spain. ribas.yolanda@gmail.com
Year 2010
Numbers Pubmed ID: 20526718

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: Amoxicillin + Clavulanate antibiotics intravenously administered at first and then orally administered when symptoms improved (pain decrease, less tenderness, and absence of fever)
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2 Antibiotics: Amoxicillin + Clavulanate antibiotics intravenously administered
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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 ... Spain
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Funder Non-industry (fully)
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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 NR
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NR
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Inclusion criteria a clinical diagnosis of uncomplicated acute diverticulitis, which was confirmed by a computed tomography (CT) scan within 24–48 h
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Exclusion criteria (1) immunocompromised patients, (2) patients under 18 years of age, (3) pregnant women, (4) clinical suspicion or CT confirmation of complicated acute diverticulitis, (5) Karnofsky performance score less than 50%, or (6) allergy to penicillin
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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 The clinical diagnosis of sigmoid diverticulitis was suggested in patients with abdominal pain localized to the left lower quadrant and tenderness upon physical examination. The presence of fever, change in bowel habits, dysuria, urinary frequency and urgency, as well as leukocytosis was also taken into account to reach the diagnosis of diverticulitis.
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Note/Comment about Design (or overall study)
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Baseline Characteristics
Question Antibiotics: Amoxicillin + Clavulanate Antibiotics: Amoxicillin + Clavulanate Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant race/ethnicity characteristics Male 52 Male 52
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Participant Age - Continuous data (in years) Mean 56 Mean 56
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95% CI 50-62 95% CI 45-57
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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) No data entered.
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 duration of symptoms (mean 77 hours) duration of symptoms (mean 47 hours)
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Number of Prior Episodes of Diverticulitis (continuous) Mean 1.2 Mean 1.5
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95% CI 0.9-1.5 95% CI 0.9-2.1
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Results & Comparisons


Results Data
P-Value
Outcome: Treatment failure      Population: All Participants Between-Arm Comparisons
Time Point Measure Antibiotics: Amoxicillin + Clavulanate Antibiotics: Amoxicillin + Clavulanate Comparison Measure Antibiotics: Amoxicillin + Clavulanate vs. Antibiotics: Amoxicillin + Clavulanate


Enter a numeric value or title (required) years

N Analyzed 22 22 1.000
Counts 2 1
Percentage 9.1 4.5


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. 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.