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Study Title and Description

Outcomes of laparoscopic versus open colectomy in elective surgery for diverticulitis.



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 Outcomes of laparoscopic versus open colectomy in elective surgery for diverticulitis.
Author Masoomi H., Buchberg B., Nguyen B., Tung V., Stamos MJ., Mills S.
Country Department of Surgery, University of California Irvine Medical Center, 333 City Boulevard West, Suite 850, Orange, CA 92868, USA.
Year 2011
Numbers Pubmed ID: 21732208

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 surgery
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2 Elective surgery Laparoscopy
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Design Details
Question... Follow Up Answer Follow-up Answer
Specific KQ KQ 4c: Surgery (recur prev)
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KQ 4c: Surgery (recur prev)
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KQ 4c: Surgery (recur prev)
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KQ 4c: Surgery (recur prev)
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KQ 4c: Surgery (recur prev)
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KQ 4c: Surgery (recur prev)
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KQ 4c: Surgery (recur prev)
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Study Design Other single group study (for harms only)
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Other single group study (for harms only)
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Other single group study (for harms only)
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Other single group study (for harms only)
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Other single group study (for harms only)
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Country USA
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USA
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USA
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USA
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USA
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USA
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USA
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Funder Non-industry (fully)
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Study name Nationwide Inpatient Sample (2002-2007)
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Associated articles Other studies: 18639223, 27422847
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ClinicalTrials.gov identifier
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Start and end years of the Study 2002
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2007
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Inclusion criteria Hospitalizations resulting from elective colon resection were identified with ICD procedure code and then divided into open surgery and laparoscopy groups.
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Exclusion criteria Urgent colon 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) ... patients included using ICD codes for elective colon resections
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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 All discharges with International Classification of Disease (ICD) procedure codes [sigmoidectomy (45.76) or anterior resection (48.62, 48.63)] with a primary diagnosis of diverticulitis (codes 562.11 and 562.13) were selected from 2002 to 2007; those patients with the admission code for an elective operation were identified and utilized in the study.
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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 47.1 Male 47.4
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White 89 White 84.9
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Black 3.4 Black 3.7
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Hispanic/Latino 4.9 Hispanic/Latino 8.8
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Asian 0.3 Asian 0.1
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Participant Age - Continuous data (in years) Mean 57 Mean 55
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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
Outcome: Conversion to (or occurrence of) complicated diverticulitis      Population: All Participants
Time Point Measure Elective surgery Elective surgery


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N Analyzed 110172 14562
Percentage 1.15 0.63
Outcome: Conversion to (or occurrence of) complicated diverticulitis      Population: All Participants
Time Point Measure Elective surgery Elective surgery


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N Analyzed 110172 14562
Percentage 23.79 17.34
Outcome: Mortality - Diverticulitis-related      Population: All Participants
Time Point Measure Elective surgery Elective surgery


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N Analyzed 110172 14562
Percentage 0.54 0.13


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. Low
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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.