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Study Title and Description

Uncomplicated diverticulitis, more complicated than we thought.



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 Uncomplicated diverticulitis, more complicated than we thought.
Author XXXBoostrom SY., Wolff BG., Cima RR., Merchea A., Dozois EJ., Larson DW.
Country Division of Colon and Rectal Surgery, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USA.
Year 2012
Numbers Pubmed ID: 22696233

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 Arm 1: Acute resolving uncomplicated diverticulitis
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2 Elective surgery Arm2: Chronic/ smoldering uncomplicated diverticulitis
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3 Elective surgery Arm3: Atypical uncomplicated diverticulitis
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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 USA
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Funder Not reported (or unclear)
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Study name Mayo Clinic, Rochester
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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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2009
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Inclusion criteria patients who underwent sigmoid resection for a diagnosis of diverticulitis
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Exclusion criteria emergent resection
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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? ... 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 Acute resolving uncomplicated diverticulitis is defined as discrete episodes of left lower quadrant abdominal pain, fever, leukocytosis, and evidence of inflammation on imaging that resolve with conservative management. Chronic/ smoldering uncomplicated diverticulitis is defined as symptoms of left lower quadrant abdominal pain and evidence of inflammation (elevated white blood cell count, fever, CT evidence of inflammation) that does not improve with the traditional antibiotic regimen, or re-exacerbation with cessation of antibiotics, for at least 3 months’ duration. Atypical uncomplicated diverticulitis is defined as symptoms of left lower quadrant pain and possible alterations in bowel habits for a period of at least 3 months; however, other clinical and radiographic evidence of diverticulitis is not present.
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Note/Comment about Design (or overall study)
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Baseline Characteristics
Question Elective surgery Elective surgery Elective surgery Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant race/ethnicity characteristics Male 45 Male 38 Male 37
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Participant Age - Continuous data (in years) Median 63 Median 66 Median 64
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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 No data entered.
KQ 4: Time Since Last Episode of Diverticulitis No data entered.
Note/Comment about baseline characteristics Duration of symptoms ranged from 3 months to 3 years (mean 7.5 months) Duration of symptoms in the atypical group ranged from 3 months to 18 years (mean 21.9 months)
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Number of Prior Episodes of Diverticulitis (continuous) Median 3
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Range 1-15
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Results & Comparisons


Results Data
Outcome: Diverticulitis-related morbidities      Population: All Participants
Time Point Measure Elective surgery Elective surgery Elective surgery


30 days

N Analyzed 564 66 54
Counts 199 22 26
Percentage 35.3 33.3 48.1
Outcome: AE - Return to OR or unplanned procedure (CD III)      Population: All Participants
Time Point Measure Elective surgery Elective surgery Elective surgery


Enter a numeric value or title (required) years

N Analyzed 564 66 54
Counts 8 0 1
Percentage 1.4 0 1.9
Outcome: AE - Bleed requiring transfusion (CD II)      Population: All Participants
Time Point Measure Elective surgery Elective surgery Elective surgery


Enter a numeric value or title (required) years

N Analyzed 564 66 54
Counts 28 1 0
Percentage 5.0 1.5 0
Outcome: AE - Acute Renal Failure      Population: All Participants
Time Point Measure Elective surgery Elective surgery Elective surgery


Enter a numeric value or title (required) years

N Analyzed 564 66 54
Counts 5 0 0
Percentage 0.9 0 0
Outcome: AE - Infection requiring Abx (CD II)      Population: All Participants
Time Point Measure Elective surgery Elective surgery Elective surgery


Enter a numeric value or title (required) years

N Analyzed 564 66 54
Counts 12 1 1
Percentage 2.1 1.5 1.9
Outcome: AE - Major cardiac event (CD IV)      Population: All Participants
Time Point Measure Elective surgery Elective surgery Elective surgery


Enter a numeric value or title (required) years

N Analyzed 564 66 54
Counts 9 2 2
Percentage 1.6 3.0 3.7
Outcome: AE - Stroke (CD IV)      Population: All Participants
Time Point Measure Elective surgery Elective surgery Elective surgery


Enter a numeric value or title (required) years

N Analyzed 564 66 54
Counts 2 0 0
Percentage 0.4 0 0
Outcome: AE - Major pulmonary event (CD IV)      Population: All Participants
Time Point Measure Elective surgery Elective surgery Elective surgery


Enter a numeric value or title (required) years

N Analyzed 564 66 54
Counts 8 0 0
Percentage 1.4 0 0
Outcome: AE - 30 day mortality (post-surgical, CD V)      Population: All Participants
Time Point Measure Elective surgery Elective surgery Elective surgery


Enter a numeric value or title (required) years

N Analyzed 564 66 54
Counts 2 0 0
Percentage 0.4 0 0


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 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.