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Study Title and Description

Risk of Emergency Surgery or Death After Initial Nonoperative Management of Complicated Diverticulitis in Scotland and Switzerland.



Key Questions Addressed
4 KEY QUESTION 4 KQ 4: What are the effects, comparative effects, and harms of pharmacological interventions (e.g., mesalamine), non-pharmacological interventions (e.g., medical nutrition therapy), and elective surgery to prevent recurrent diverticulitis? • Do the (comparative) effects and harms vary by patient characteristics, course of illness, or other factors?
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Primary Publication Information
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TitleData
Title Risk of Emergency Surgery or Death After Initial Nonoperative Management of Complicated Diverticulitis in Scotland and Switzerland.
Author von Strauss und Torney M., Moffa G., Kaech M., Haak F., Riss S., Deutschmann E., Bucher HC., Kettelhack C., Paterson HM.
Country Clarunis, Department of Visceral Surgery, University Centre for Gastrointestinal and Liver Diseases, St. Clara Hospital and University Hospital Basel, Basel, Switzerland.
Year 2020
Numbers Pubmed ID: 32401298

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 Elective surgery
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Design Details
Question... Follow Up Answer Follow-up Answer
Specific KQ KQ 4c: Surgery (recur prev)
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Study Design Other single group study (for harms only)
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Country UK
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Other ... Switzerland
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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 2005
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2015
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Inclusion criteria (ICD-10) diagnosis of primary colonic diverticulitis or diverticulosis in combination with a complication of acute diverticulitis as the primary diagnosis (eg, peritonitis or sepsis), who underwent elective interval resection.
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Exclusion criteria
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Specific population? ... Population specified... ... complicated diverticulitis
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Was diverticulitis diagnosed with CT? ... Unclear/Multiple methods (explain) ...
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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 ICD code
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Note/Comment about Design (or overall study)
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Baseline Characteristics
Question Elective surgery Total Comments
AnswerFollow-up AnswerFollow-up
Participant race/ethnicity characteristics Male NR
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Participant Age - Continuous data (in years) Mean NR
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Participant Age - Categorical data NR
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Participants with Un/Complicated Diverticulitis Complicated diverticulitis 100
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Specific Complications of Diverticulitis NR
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Number of Prior Episodes of Diverticulitis (categorical) Not reported
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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) Not reported
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Results & Comparisons


Results Data
Outcome: AE - 30 day mortality (post-surgical, CD V)      Population: All Participants
Time Point Measure Elective surgery


median 57 months

N Analyzed 30
Counts 3511
Percentage 0.85
Outcome: AE - Return to OR or unplanned procedure (CD III)      Population: All Participants
Time Point Measure Elective surgery


median 57 months

N Analyzed 159
Counts 3511
Percentage 4.53
note (Emerg op or death) minus (death)


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
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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
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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
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Q20: Cochrane - Incomplete outcome data (attrition bias): Attrition bias due to amount, nature or handling of incomplete outcome data No
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Q21: Cochrane - Selective Reporting (reporting bias): Reporting bias due to selective outcome reporting No
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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
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Q1: ROBINS-I 1.1 Is there potential for confounding of the effect of intervention in this study? No
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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? Not Applicable
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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? No
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Q6: ROBINS-I - Risk of bias judgement for BIAS DUE TO CONFOUNDING No
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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 Whole study was initial conservative treatment. We eval only those with subsequent surgery.
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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? 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?
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Q13: ROBINS-I - Risk of bias judgement for BIAS IN SELECTION OF PARTICIPANTS INTO THE STUDY No
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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? Yes
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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? No
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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.