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? |
Primary Publication Information
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 | |
2 | Elective surgery | Laparoscopic procedure |
Question... Follow Up | Answer | Follow-up Answer | |
---|---|---|---|
Specific KQ | KQ 4c: Surgery (recur prev) | ||
Study Design | Other single group study (for harms only) | ||
Country | USA | ||
Funder | Not reported (or unclear) | ||
Study name | ACS-NSQIP 2005-08 | ||
Associated articles | 26116319, 27120447 | ||
ClinicalTrials.gov identifier | |||
Start and end years of the Study | 2005 | ||
2008 | |||
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. | ||
Exclusion criteria | Defined by the NSQIP to have undergone emergency surgery. Definition includes patients who had surgery within 12 hours of admission. | ||
if not an RCT, what was the directionality? | Retrospective | ||
Was diverticulitis diagnosed with CT? ... | Unclear/Multiple methods (explain) ... | ICD-9 codes | |
If NRCS, what analytic method was used to account for differences between study arms? | |||
How was diverticulitis diagnosed | Diverticular disease were identified by ICD-9 codes | ||
Note/Comment about Design (or overall study) |
Baseline Characteristics
Question | Elective surgery | Elective surgery | Total | Comments | |||
---|---|---|---|---|---|---|---|
Answer | Follow-up | Answer | Follow-up | Answer | Follow-up | ||
Participant race/ethnicity characteristics | Male | 46.9 | Male | 49.1 | |||
White | 79.2 | White | 83.5 | ||||
Black | 6.9 | Black | 3.4 | ||||
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 | ||||
Participant Age - Continuous data (in years) | Mean | 59.2 | Mean | 55.6 | |||
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
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 |
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 |
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 |
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 |
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 | |||
Q15: Cochrane - Allocation concealment (selection bias): Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment | |||
Q16: Cochrane - Blinding of participants (performance bias): Performance bias due to knowledge of the allocated interventions by participants during the study | |||
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. | |||
Q18: Cochrane - FOR OBJECTIVE OUTCOMES - Blinding of outcome assessor (detection bias): Detection bias due to knowledge of the allocated interventions by outcome assessors. | |||
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. | |
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. | |
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. | |
Q1: ROBINS-I 1.1 Is there potential for confounding of the effect of intervention in this study? | |||
Q3: ROBINS-I 1.4. Did the authors use an appropriate analysis method that controlled for all the important confounding domains? | |||
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? | |||
Q5: ROBINS-I 1.6. Did the authors control for any post-intervention variables that could have been affected by the intervention? | |||
Q6: ROBINS-I - Risk of bias judgement for BIAS DUE TO CONFOUNDING | |||
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? | |||
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? | |||
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? | |||
Q10: ROBINS-I 2.4. Do start of follow-up and start of intervention coincide for most participants? | |||
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? | |||
Q13: ROBINS-I - Risk of bias judgement for BIAS IN SELECTION OF PARTICIPANTS INTO THE STUDY | |||
Q2: Did the study divide the follow up time of each individual participant into the different interventions? | |||
Q11: Did the start and follow up calendar years coincide for most participants in the study? | |||
Q19: Cochrane - FOR SUBJECTIVE OUTCOMES - Blinding of outcome assessor (detection bias): Detection bias due to knowledge of the allocated interventions by outcome assessors. | |||
Q23: NHLBI - Were eligibility/selection criteria for the study population prespecified and clearly described? | Yes | ||
Q24: NHLBI - Was the test/service/intervention clearly described and delivered consistently across the study population? | Yes | ||
Q25: NHLBI - Were the outcome measures prespecified, clearly defined, valid, reliable, and assessed consistently across all study participants? | Yes |
Quality Rating
No quality rating data was found.