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Study Title and Description

Mild colonic diverticulitis can be treated without antibiotics. A case-control study.



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 Mild colonic diverticulitis can be treated without antibiotics. A case-control study.
Author de Korte N., Kuyvenhoven JP., van der Peet DL., Felt-Bersma RJ., Cuesta MA., Stockmann HB.
Country Department of Surgery, Kennemer Gasthuis, Haarlem, The Netherlands. ndekorte@yahoo.com
Year 2012
Numbers Pubmed ID: 21689302

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)
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2 No intervention (non-placebo)
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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 ... The Netherlands
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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
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Start and end years of the Study 2001
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2007
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Inclusion criteria Image-confirmed acute mild diverticulitis of the sigmoid colon in which the decision (implied based on review of charts) was made to treat conservatively
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Exclusion criteria NR
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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) ... CT or U/S
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If NRCS, what analytic method was used to account for differences between study arms? logistic regression
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How was diverticulitis diagnosed image confirmed acute mild based on Ambrosetti or Hinchey 1a criteria
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Note/Comment about Design (or overall study)
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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 36 Male 29
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Participant Age - Continuous data (in years) Mean 63 Mean 61
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Range 34–94 Range 27–92
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Participant Age - Categorical data No data entered.
Participants with Un/Complicated Diverticulitis Complicated diverticulitis 100 Complicated diverticulitis 100
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Specific Complications of Diverticulitis 'One patient underwent successful percutaneous drainage of an abscess and later had an elective laparoscopic sigmoid resection'
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0.4
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Number of Prior Episodes of Diverticulitis (categorical) Not reported Not reported Not reported
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History of (Prior) Complicated Diverticulitis Not reported Not reported Not reported
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KQ 4: Time Since Last Episode of Diverticulitis Not reported Not reported Not reported
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Note/Comment about baseline characteristics No data entered.
Number of Prior Episodes of Diverticulitis (continuous) Not reported Not reported Not reported
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Results & Comparisons


Results Data
P-Value
Outcome: Treatment failure-surgery and/or percutaneous drainage      Population: All Participants Between-Arm Comparisons
Time Point Measure Antibiotics: Multiple (discretionary or undefined) No intervention (non-placebo) Comparison Measure ERROR vs. ERROR


mean 50 (range 12–100) months

 N Analyzed 81 191 0.350
Counts 5 7
P-Value
Outcome: Urgent or emergency surgery      Population: All Participants Between-Arm Comparisons
Time Point Measure Antibiotics: Multiple (discretionary or undefined) No intervention (non-placebo) Comparison Measure Antibiotics: Multiple (discretionary or undefined) vs. No intervention (non-placebo)


mean 50 (range 12–100) months

 N Analyzed 81 191
Counts 3 6
Outcome: Diverticulitis-related morbidities      Population: All Participants
Time Point Measure Antibiotics: Multiple (discretionary or undefined) No intervention (non-placebo)


mean 50 (range 12–100) months

 N Analyzed 81 191
Counts 2 1
P-Value
Outcome: Recurrence of diverticulitis      Population: All Participants Between-Arm Comparisons
Time Point Measure Antibiotics: Multiple (discretionary or undefined) No intervention (non-placebo) Comparison Measure Antibiotics: Multiple (discretionary or undefined) vs. No intervention (non-placebo)


mean 50 (range 12–100) months

 N Analyzed 81 191 0.055
Counts 12 14
P-Value
Outcome: Mortality - All-cause (non-AE)      Population: All Participants Between-Arm Comparisons
Time Point Measure Antibiotics: Multiple (discretionary or undefined) No intervention (non-placebo) Comparison Measure Antibiotics: Multiple (discretionary or undefined) vs. No intervention (non-placebo)


mean 50 (range 12–100) months

 N Analyzed 81 191 0.508
Counts 1 1
Outcome: Diverticulitis-related morbidities      Population: All Participants
Time Point Measure Antibiotics: Multiple (discretionary or undefined) No intervention (non-placebo)


mean 50 (range 12–100) months

 N Analyzed 81 191
Counts 1 3
P-Value
Outcome: Diverticulitis-related morbidities      Population: All Participants Between-Arm Comparisons
Time Point Measure Antibiotics: Multiple (discretionary or undefined) No intervention (non-placebo) Comparison Measure ERROR vs. ERROR


mean 50 (range 12–100) months

 N Analyzed 81 191
Counts 4 4
P-Value
Outcome: Diverticulitis-related morbidities      Population: All Participants Between-Arm Comparisons
Time Point Measure Antibiotics: Multiple (discretionary or undefined) No intervention (non-placebo) Comparison Measure Antibiotics: Multiple (discretionary or undefined) vs. No intervention (non-placebo)


mean 50 (range 12–100) months

 N Analyzed 81 191 0.347
Counts 5 7
P-Value
Outcome: Length of hospital (or intensive care unit) stay      Population: All Participants Between-Arm Comparisons
Time Point Measure Antibiotics: Multiple (discretionary or undefined) No intervention (non-placebo) Comparison Measure Antibiotics: Multiple (discretionary or undefined) vs. No intervention (non-placebo)


mean 50 (range 12–100) months

 N Analyzed 81 191 0.666
Mean 7 7
SD
SE


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 Patients not blinded
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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 personnel knew treatment status
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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. Yes Patient data was made anonymous after being entered in to the database
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Q20: Cochrane - Incomplete outcome data (attrition bias): Attrition bias due to amount, nature or handling of incomplete outcome data No Figure 1 flowchart indicates no loss of patients (unclear if accurate)
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Q21: Cochrane - Selective Reporting (reporting bias): Reporting bias due to selective outcome reporting Unsure
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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? Yes case-control. Two hospitals recruited pts - one with an antibiotic protocol, the other without. In both, decision to give antibiotic was made by treating physician
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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? Yes Logistic multiple regression (NB, only for outcome of recurrence)
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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? Yes
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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 Yes Moderate risk of bias - likely some, but several important confounders were identified, appear to have been measured validity, and were used for adjustment
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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 Selected based on prospectively coded hospital registry ICD-9 codes for diverticulitis. Inclusion criteria confirmed with diagnostic information (CT and Hinchey criteria) pre-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? 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? No
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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
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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. Yes Patient data was made anonymous after being entered in to the database
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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 Somewhat, for conservative diet treatment, but no information given about antibiotic regimens
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Q25: NHLBI - Were the outcome measures prespecified, clearly defined, valid, reliable, and assessed consistently across all study participants? No Vague and potentially partially subjective based on need for clinical care (need for surgery, need for drainage)
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Quality Rating
Guideline Used Overall Rating