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Study Title and Description

Antibiotics Do Not Reduce Length of Hospital Stay for Uncomplicated Diverticulitis in a Pragmatic Double-Blind Randomized 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 Antibiotics Do Not Reduce Length of Hospital Stay for Uncomplicated Diverticulitis in a Pragmatic Double-Blind Randomized Trial.
Author Jaung R., Nisbet S., Gosselink MP., Di Re A., Keane C., Lin A., Milne T., Su'a B., Rajaratnam S., Ctercteko G., Hsee L., Rowbotham D., Hill A., Bissett I.
Country Department of Surgery, University of Auckland, Auckland, New Zealand.
Year 2020
Numbers Pubmed ID: 32240832

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: po amoxicillin/clavulanic +- IV cefuroxime & po metronidazole
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2 Placebo
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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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KQ 2b: Antibiotics (acute)
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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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RCT
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RCT
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RCT
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Country ... Specify Other ... New Zealand, Australia
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Funder Non-industry (fully)
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Study name STAND study (Selective Treatment with Antibiotics for Non-complicated Diverticulitis)
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Associated articles
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ClinicalTrials.gov identifier
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Start and end years of the Study 2015
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2019
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Inclusion criteria CT-proven Hinchey 1a uncomplicated acute diverticulitis
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Exclusion criteria ≥2 criteria for Systemic Inflammatory Response Syndrome (SIRS), temperature <36° or >38° C, heart rate >90 beats per minute, respiratory rate >20 breaths per minute or PaCO3 <32mmHg, white cell count <4 or >12 x 10 9/L); were unable to give consent, language barrier or cognitive impairment; previous drug reactions; prior usage of steroids; had been administered regular immunomodulators or biologics within the six months prior to presentation; used regular NSAIDs for greater than a week prior to presentation; had been administered >1 dose of intravenous or >2 doses of oral antibiotics during this illness but prior to enrolment in the study; were pregnant; had an American Society of Anesthesiologists physical status classification (ASA) ≥4; or had CT evidence of complicated acute diverticulitis.
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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 CT
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Note/Comment about Design (or overall study)
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Baseline Characteristics
Question Antibiotics: po amoxicillin/clavulanic +- IV cefuroxime & po metronidazole Placebo Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant race/ethnicity characteristics Male 40 Male 44
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Participant Age - Continuous data (in years) Median 56 (probably median) Median 59
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IQR 53-59 (probably IQR) IQR 57-62
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Participant Age - Categorical data No data entered.
Participants with Un/Complicated Diverticulitis Complicated diverticulitis 0
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Specific Complications of Diverticulitis No data entered.
Number of Prior Episodes of Diverticulitis (categorical) 0 71 0 68
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History of (Prior) Complicated Diverticulitis Not reported
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KQ 4: Time Since Last Episode of Diverticulitis Not reported
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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: Need for procedural intervention      Population: All Participants Between-Arm Comparisons
Time Point Measure Antibiotics: po amoxicillin/clavulanic +- IV cefuroxime & po metronidazole Placebo Comparison Measure ERROR vs. ERROR


30 days

 N Analyzed 84 94 0.1
Counts 2 0
note 1 incorrectly diagnosed as Hinchey 1a instead of complicated. 1 with pneumonia requiring drainage
P-Value P-Value
Outcome: Hospitalization (or re-hospitalization) for diverticulitis (avoidance)      Population: All Participants Between-Arm Comparisons
Time Point Measure Antibiotics: po amoxicillin/clavulanic +- IV cefuroxime & po metronidazole Placebo Comparison Measure ERROR vs. ERROR


1 weeks

 N Analyzed 84 94 0.07
Counts 5 1


30 days

 N Analyzed 84 94 0.3
Counts 5 10
P-Value
Outcome: Mortality - All-cause (non-AE)      Population: All Participants Between-Arm Comparisons
Time Point Measure Antibiotics: po amoxicillin/clavulanic +- IV cefuroxime & po metronidazole Placebo Comparison Measure ERROR vs. ERROR


30 days

 N Analyzed 84 94 0.3
Counts 1 0
note Stroke, unrelated to diverticulitis
Median Difference 25th percentile 75th percentile
Outcome: Length of hospital stay      Population: All Participants Between-Arm Comparisons
Time Point Measure Antibiotics: po amoxicillin/clavulanic +- IV cefuroxime & po metronidazole Placebo Comparison Measure Antibiotics: po amoxicillin/clavulanic +- IV cefuroxime & po metronidazole vs. Placebo


N/A N/A

 N Analyzed 84 94 -5.9
Median 40.0 45.8 -15.5
25th Percentile 24.4 26.5 3.7
75th Percentile 57.6 60.2
P-Value
Outcome: Pain      Population: All Participants Between-Arm Comparisons
Time Point Measure Antibiotics: po amoxicillin/clavulanic +- IV cefuroxime & po metronidazole Placebo Comparison Measure ERROR vs. ERROR


24 hours

 N Analyzed 84 94 0.9
Median 2 3
25th Percentile 1 2
75th Percentile 3 3
Mean 3.2 3.0
95% CI low 2.4 2.3
95% CI high 3.9 3.7


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 No low risk
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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 No low risk
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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 low risk
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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 low risk
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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 low risk
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Q20: Cochrane - Incomplete outcome data (attrition bias): Attrition bias due to amount, nature or handling of incomplete outcome data No low risk
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Q21: Cochrane - Selective Reporting (reporting bias): Reporting bias due to selective outcome reporting No low risk
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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. No low risk
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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. No low risk
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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.