Advanced Search

Study Preview



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?
  • Comments Comments (
    0
    ) |

Primary Publication Information
  • Comments Comments (
    0
    ) |
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
  • Comments Comments (
    0
    ) |
2 Elective surgery Laparoscopic procedure
  • Comments Comments (
    0
    ) |

Design Details
Question... Follow Up Answer Follow-up Answer
Specific KQ KQ 4c: Surgery (recur prev)
  • Comments Comments (
    0
    ) |
Study Design Other single group study (for harms only)
  • Comments Comments (
    0
    ) |
Country USA
  • Comments Comments (
    0
    ) |
Funder Not reported (or unclear)
  • Comments Comments (
    0
    ) |
Study name ACS-NSQIP 2005-08
  • Comments Comments (
    0
    ) |
Associated articles 26116319, 27120447
  • Comments Comments (
    0
    ) |
ClinicalTrials.gov identifier
  • Comments Comments (
    0
    ) |
Start and end years of the Study 2005
  • Comments Comments (
    0
    ) |
2008
  • Comments Comments (
    0
    ) |
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.
  • Comments Comments (
    0
    ) |
Exclusion criteria Defined by the NSQIP to have undergone emergency surgery. Definition includes patients who had surgery within 12 hours of admission.
  • Comments Comments (
    0
    ) |
if not an RCT, what was the directionality? Retrospective
  • Comments Comments (
    0
    ) |
Was diverticulitis diagnosed with CT? ... Unclear/Multiple methods (explain) ... ICD-9 codes
  • Comments Comments (
    0
    ) |
If NRCS, what analytic method was used to account for differences between study arms?
  • Comments Comments (
    0
    ) |
How was diverticulitis diagnosed Diverticular disease were identified by ICD-9 codes
  • Comments Comments (
    0
    ) |
Note/Comment about Design (or overall study)
  • Comments Comments (
    0
    ) |


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
  • Comments Comments (
    0
    ) |
White 79.2 White 83.5
  • Comments Comments (
    0
    ) |
Black 6.9 Black 3.4
  • Comments Comments (
    0
    ) |
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
  • Comments Comments (
    0
    ) |
Participant Age - Continuous data (in years) Mean 59.2 Mean 55.6
  • Comments Comments (
    0
    ) |
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
  • Comments Comments (
    0
    ) |
Q15: Cochrane - Allocation concealment (selection bias): Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
  • Comments Comments (
    0
    ) |
Q16: Cochrane - Blinding of participants (performance bias): Performance bias due to knowledge of the allocated interventions by participants during the study
  • Comments Comments (
    0
    ) |
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.
  • Comments Comments (
    0
    ) |
Q18: Cochrane - FOR OBJECTIVE OUTCOMES - Blinding of outcome assessor (detection bias): Detection bias due to knowledge of the allocated interventions by outcome assessors.
  • Comments Comments (
    0
    ) |
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.
  • Comments Comments (
    0
    ) |
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.
  • Comments Comments (
    0
    ) |
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.
  • Comments Comments (
    0
    ) |
Q1: ROBINS-I 1.1 Is there potential for confounding of the effect of intervention in this study?
  • Comments Comments (
    0
    ) |
Q3: ROBINS-I 1.4. Did the authors use an appropriate analysis method that controlled for all the important confounding domains?
  • Comments Comments (
    0
    ) |
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?
  • Comments Comments (
    0
    ) |
Q5: ROBINS-I 1.6. Did the authors control for any post-intervention variables that could have been affected by the intervention?
  • Comments Comments (
    0
    ) |
Q6: ROBINS-I - Risk of bias judgement for BIAS DUE TO CONFOUNDING
  • Comments Comments (
    0
    ) |
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?
  • Comments Comments (
    0
    ) |
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?
  • Comments Comments (
    0
    ) |
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?
  • Comments Comments (
    0
    ) |
Q10: ROBINS-I 2.4. Do start of follow-up and start of intervention coincide for most participants?
  • Comments Comments (
    0
    ) |
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?
  • Comments Comments (
    0
    ) |
Q13: ROBINS-I - Risk of bias judgement for BIAS IN SELECTION OF PARTICIPANTS INTO THE STUDY
  • Comments Comments (
    0
    ) |
Q2: Did the study divide the follow up time of each individual participant into the different interventions?
  • Comments Comments (
    0
    ) |
Q11: Did the start and follow up calendar years coincide for most participants in the study?
  • Comments Comments (
    0
    ) |
Q19: Cochrane - FOR SUBJECTIVE OUTCOMES - Blinding of outcome assessor (detection bias): Detection bias due to knowledge of the allocated interventions by outcome assessors.
  • Comments Comments (
    0
    ) |
Q23: NHLBI - Were eligibility/selection criteria for the study population prespecified and clearly described? Yes
  • Comments Comments (
    0
    ) |
Q24: NHLBI - Was the test/service/intervention clearly described and delivered consistently across the study population? Yes
  • Comments Comments (
    0
    ) |
Q25: NHLBI - Were the outcome measures prespecified, clearly defined, valid, reliable, and assessed consistently across all study participants? Yes
  • Comments Comments (
    0
    ) |

Quality Rating
No quality rating data was found.