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Study Title and Description

Laparoscopy improves short-term outcomes after surgery for diverticular disease.



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 Laparoscopy improves short-term outcomes after surgery for diverticular disease.
Author Russ AJ., Obma KL., Rajamanickam V., Wan Y., Heise CP., Foley EF., Harms B., Kennedy GD.
Country Department of Surgery, Section of Colon and Rectal Surgery, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin 53972, USA.
Year 2010
Numbers Pubmed ID: 20193685

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 Open procedure
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2 Elective surgery Laparoscopic procedure
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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 ACS-NSQIP 2005-08
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Associated articles 26116319, 27120447
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ClinicalTrials.gov identifier
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Start and end years of the Study 2005
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2008
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Inclusion criteria Emergency and nonemergency cardiac and noncardiac surgery. Diverticular disease were identified by ICD-9 codes and then categorized based on procedure type using CPT codes.
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Exclusion criteria Defined by the NSQIP to have undergone emergency surgery. Definition includes patients who had surgery within 12 hours of admission.
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if not an RCT, what was the directionality? Retrospective
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Was diverticulitis diagnosed with CT? ... Unclear/Multiple methods (explain) ... ICD-9 codes
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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 Diverticular disease were identified by ICD-9 codes
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Note/Comment about Design (or overall study)
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Baseline Characteristics
Question Elective surgery Elective surgery Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant race/ethnicity characteristics Male 46.9 Male 49.1
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White 79.2 White 83.5
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Black 6.9 Black 3.4
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Other (or specific) race/ethnicity 1 - include race/ethnicity in parentheses 14 Other (or specific) race/ethnicity 1 - include race/ethnicity in parentheses 13.2
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Participant Age - Continuous data (in years) Mean 59.2 Mean 55.6
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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 No data entered.
Number of Prior Episodes of Diverticulitis (continuous) No data entered.



Results & Comparisons


Results Data
P-Value Odds Ratio (OR) 95% CI low 95% CI high Adj. Odds Ratio (OR) Adj. 95% CI low Adj. 95% CI high
Outcome: AE - Sepsis (CD IV)      Population: All Participants Between-Arm Comparisons
Time Point Measure Elective surgery Elective surgery Comparison Measure Elective surgery vs. Elective surgery


Enter a numeric value or title (required) years

 N Analyzed 3468 3502 <0.0001
Percentage 4.5 2.2 0.662
0.485
0.902
0.659
0.483
0.901
P-Value Odds Ratio (OR) 95% CI low 95% CI high Adj. Odds Ratio (OR) Adj. 95% CI low Adj. 95% CI high
Outcome: AE - Sepsis (CD IV)      Population: All Participants Between-Arm Comparisons
Time Point Measure Elective surgery Elective surgery Comparison Measure Elective surgery vs. Elective surgery


Enter a numeric value or title (required) years

 N Analyzed 3468 3502 <0.0001
Percentage 4.5 2.2 0.429
0.249
0.74
0.44
0.255
0.762
P-Value
Outcome: AE - Bleed requiring transfusion (CD II)      Population: All Participants Between-Arm Comparisons
Time Point Measure Elective surgery Elective surgery Comparison Measure Elective surgery vs. Elective surgery


Enter a numeric value or title (required) years

 N Analyzed 3468 3502 <0.0001
Percentage 6.7 0.9
P-Value
Outcome: AE - 30 day mortality (post-surgical, CD V)      Population: All Participants Between-Arm Comparisons
Time Point Measure Elective surgery Elective surgery Comparison Measure Elective surgery vs. Elective surgery


30 days

 N Analyzed 3468 3502 0.0004
Percentage 1.1 0.4
P-Value Odds Ratio (OR) 95% CI low 95% CI high Adj. Odds Ratio (OR) Adj. 95% CI low Adj. 95% CI high
Outcome: AE - Major pulmonary event (CD IV)      Population: All Participants Between-Arm Comparisons
Time Point Measure Elective surgery Elective surgery Comparison Measure Elective surgery vs. Elective surgery


N/A years

 N Analyzed 3468 3502 0.0039
Percentage 0.8 0.3 0.503
0.234
1.078
0.487
0.226
1.047


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 No Missing outcome data was <30% for long-term follow-up and reasons for missing data were well described.
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Q21: Cochrane - Selective Reporting (reporting bias): Reporting bias due to selective outcome reporting No Study protocol is not available; however, it seems that all outcomes of interest were reported.
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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 Study appears to be free of other sources of bias.
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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.