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Study Title and Description

Short-term Intravenous Antibiotic Treatment in Uncomplicated Diverticulitis Does Not Increase the Risk of Recurrence Compared to Long-term Treatment.



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 Short-term Intravenous Antibiotic Treatment in Uncomplicated Diverticulitis Does Not Increase the Risk of Recurrence Compared to Long-term Treatment.
Author Scarpa CR., Buchs NC., Poncet A., Konrad-Mugnier B., Gervaz P., Morel P., Ris F.
Country Clinic for Visceral and Transplantation Surgery, Department of Surgery, University Hospital of Geneva, Geneva, Switzerland.
Year 2015
Numbers Pubmed ID: 25960972

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: short course IV
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2 Antibiotics: long course IV
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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 Nonrandomized comparative study (NRCS)
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Country ... Specify Other ... Switzerland
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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 NCT01015378
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Start and end years of the Study 2007
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2012
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Inclusion criteria 1st episode CT-confirmed uncomplicated diverticulitis requiring hospitalization
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Exclusion criteria complicated diverticulitis (Hinchey-Ib class and above), <18 yrs of age, chronic IBD or a tumor
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if not an RCT, what was the directionality? Prospective
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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? none; crude w/long-term outcome (only these of potential interest)
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How was diverticulitis diagnosed physical examination and laboratory tests revealing an inflammatory syndrome and was confirmed by using an abdominal CT scan
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Note/Comment about Design (or overall study)
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Baseline Characteristics
Question Antibiotics: short course IV Antibiotics: long course IV Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant race/ethnicity characteristics Male 47.8 Male 51.0
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Participant Age - Continuous data (in years) Median 55.5 Median 60 Median 56
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Range 24–81 Range 30–86 Range 24–85
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Participant Age - Categorical data No data entered.
Participants with Un/Complicated Diverticulitis Uncomplicated diverticulitis 100 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 0 100
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History of (Prior) Complicated Diverticulitis No 100 No 100 No 100
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KQ 4: Time Since Last Episode of Diverticulitis No data entered.
Note/Comment about baseline characteristics although not randomized into groups (and uneven in number), inflammation characteristics (fever, leukocyte count, CRP) appear balanced although not randomized into groups (and uneven in number), inflammation characteristics (fever, leukocyte count, CRP) appear balanced
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Number of Prior Episodes of Diverticulitis (continuous) No data entered.



Results & Comparisons


Results Data
P-Value
Outcome: Recurrence of diverticulitis      Population: All Participants Between-Arm Comparisons
Time Point Measure Antibiotics: short course IV Antibiotics: long course IV Comparison Measure Antibiotics: short course IV vs. Antibiotics: long course IV


50+/- 17 months (range 19-89) months

 N Analyzed 46 210 0.772
Counts 11 52
Outcome: Emergency surgical resection      Population: All Participants
Time Point Measure Antibiotics: short course IV Antibiotics: long course IV


50+/- 17 months (range 19-89) months

 N Analyzed 46 210
Counts 0 5
Outcome: Elective surgical treatment      Population: All Participants
Time Point Measure Antibiotics: short course IV Antibiotics: long course IV


50+/- 17 months (range 19-89) months

 N Analyzed 46 210
Counts 4 41


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 Not Applicable
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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 Not Applicable
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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 No No mention of blinding; pts likely aware of length of course of treatment
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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. No No mention of blinding; providers likely aware of length of course of treatment
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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. No No mention of blinding; assessors (prob providers) likely aware of length of course of treatment
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Q20: Cochrane - Incomplete outcome data (attrition bias): Attrition bias due to amount, nature or handling of incomplete outcome data No Small loss to follow-up (11 of 282)
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Q21: Cochrane - Selective Reporting (reporting bias): Reporting bias due to selective outcome reporting Yes Clinicialtrials.gov protocol lists 'severity and outcome of recurrent diverticulitis' and evolution in digestive symptoms and quality of life (QoL) as 3 outcomes that are not reported in this report
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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. Yes Ill defined question: not truly a comparison of short vs. long term antibiotics because short course group got 5 day oral regimen
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Q1: ROBINS-I 1.1 Is there potential for confounding of the effect of intervention in this study? Yes choice of treatment at surgeon's discretion; healthier patients may have received shorter course of Abs. Also short course group still got antibiotics (just orally)
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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? No No adjustments made, just compared baseline clinical characteristics (mostly balanced; CRP trend higher in longer term group).
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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? Not Applicable No adjustments made
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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? Not Applicable No adjustments made
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Q6: ROBINS-I - Risk of bias judgement for BIAS DUE TO CONFOUNDING Yes High risk of 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? No All comers; only restricted to those that had follow-up of 12 months or more
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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? Not Applicable
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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? Not Applicable
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Q10: ROBINS-I 2.4. Do start of follow-up and start of intervention coincide for most participants? Yes
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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? Not Applicable
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Q13: ROBINS-I - Risk of bias judgement for BIAS IN SELECTION OF PARTICIPANTS INTO THE STUDY No No apparent selection bias
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Q2: Did the study divide the follow up time of each individual participant into the different interventions? No
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Q11: Did the start and follow up calendar years coincide for most participants in the study? No Prospective cohort following 5 year span
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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. No No mention of blinding; assessors (prob providers) likely aware of length of course of treatment
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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.