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Study Title and Description

Conservative Treatment in Diverticulitis Patients with Pericolic Extraluminal Air and the Role of Antibiotic 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 Conservative Treatment in Diverticulitis Patients with Pericolic Extraluminal Air and the Role of Antibiotic Treatment.
Author XXX_Bolkenstein HE., van Dijk ST., Consten ECJ., Heggelman BGF., Hoeks CMA., Broeders IAMJ., Boermeester MA., Draaisma WA.
Country University of Twente, 5, Drienerlolaan, 7522, NB, Enschede, The Netherlands. he.bolkenstein@meandermc.nl.
Year 2019
Numbers Pubmed ID: 30859428

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: Multiple (discretionary or undefined) For the patients from the retrospective cohort, they were assigned to antibiotic treatment group if antibiotic treatment had been started within 24 h after presentation. For DIABOLO study, IV amoxicillin–clavulanic acid was chosen as broad-spectrum antibiotic treatment of choice.
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2 No intervention (non-placebo) Observational treatment
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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 ... Netherlands
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Funder Non-industry (fully)
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Study name
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Associated articles 27686365, 30807455
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ClinicalTrials.gov identifier
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Start and end years of the Study 2005
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2017
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Inclusion criteria Uncomplicated diverticulitis(only modifies Hinchey 1A) with pericolic air on CT
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Exclusion criteria signs of sepsis, clinical or radiologic evidence of abscess or diffuse peritonitis, emergency surgery, abscess drainage within 24 h after presentation
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if not an RCT, what was the directionality? Retrospective
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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? Multi variable logistic regression
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How was diverticulitis diagnosed This study included all patients with an uncomplicated diverticulitis (only modified Hinchey 1A)17–19 with pericolic air on CT.
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Note/Comment about Design (or overall study) This study obtains 39 participants from DIABOLO study and 70 patients from the retrospective single centre cohort.
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Baseline Characteristics
Question Antibiotics: Multiple (discretionary or undefined) No intervention (non-placebo) Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant race/ethnicity characteristics Male 73 Male 61 Male 67
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Participant Age - Continuous data (in years) Mean 55 Mean 52 Mean 53
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SD 12 SD 11 SD 11
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Participant Age - Categorical data No data entered.
Participants with Un/Complicated Diverticulitis No data entered.
Specific Complications of Diverticulitis No data entered.
Number of Prior Episodes of Diverticulitis (categorical) No data entered.
History of (Prior) Complicated Diverticulitis Yes 9 Yes 10 Yes 9
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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

No Results found.

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
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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
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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
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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.
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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.
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Q20: Cochrane - Incomplete outcome data (attrition bias): Attrition bias due to amount, nature or handling of incomplete outcome data
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Q21: Cochrane - Selective Reporting (reporting bias): Reporting bias due to selective outcome reporting
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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?
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Q24: NHLBI - Was the test/service/intervention clearly described and delivered consistently across the study population?
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Q25: NHLBI - Were the outcome measures prespecified, clearly defined, valid, reliable, and assessed consistently across all study participants?
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Quality Rating
No quality rating data was found.