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Study Title and Description

Risk factors for mortality and morbidity after elective sigmoid resection for diverticulitis: prospective multicenter multivariate analysis of 582 patients.



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 Risk factors for mortality and morbidity after elective sigmoid resection for diverticulitis: prospective multicenter multivariate analysis of 582 patients.
Author Pessaux P., Muscari F., Ouellet JF., Msika S., Hay JM., Millat B., Fingerhut A., Flamant Y.
Country Department of Digestive Surgery, Centre Hospitalier Universitaire, 4 rue Larrey, 49 000 Angers, France. pessauxpchuangers@yahoo.fr
Year 2004
Numbers Pubmed ID: 14639493

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 elective laparotomy for colon or rectal resection for diverticulitis
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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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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 ... Specify Other ... France
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Funder Not reported (or unclear)
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Study name French Association for Surgical Research
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Associated articles
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ClinicalTrials.gov identifier
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Start and end years of the Study 1985
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1998
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Inclusion criteria elective sigmoid resection by laparotomy at least 1.5 month after an acute episode of diverticulitis, followed by primary anastomosis with or without protective stoma.
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Exclusion criteria prior colon resection, emergency resection, surgery without resection, resection without primary anastomosis, and patients undergo- ing laparoscopic 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) ...
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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 NR
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Note/Comment about Design (or overall study) Start and end years of the study (actually the year of publication)
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Baseline Characteristics
Question Elective surgery Total Comments
AnswerFollow-up AnswerFollow-up
Participant race/ethnicity characteristics Male 46.6
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Participant Age - Continuous data (in years) No data entered.
Participant Age - Categorical data <58
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37.5
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59-75
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45.8
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>76
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16.7
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Participants with Un/Complicated Diverticulitis Not reported
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Specific Complications of Diverticulitis No data entered.
Number of Prior Episodes of Diverticulitis (categorical) Not reported
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History of (Prior) Complicated Diverticulitis Not reported
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KQ 4: Time Since Last Episode of Diverticulitis Range >1.5 months
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Note/Comment about baseline characteristics No data entered.
Number of Prior Episodes of Diverticulitis (continuous) Not reported
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Results & Comparisons


Results Data
Outcome: AE - 30 day mortality (post-surgical, CD V)      Population: All Participants
Time Point Measure Elective surgery


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N Analyzed 582
Counts 7
Percentage 1.2
Outcome: Morbidity      Population: All Participants
Time Point Measure Elective surgery


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N Analyzed 582
Counts 145
Percentage 24.9
Outcome: AE - Sepsis (CD IV)      Population: All Participants
Time Point Measure Elective surgery


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N Analyzed 582
Counts 9
Percentage 1.5
Outcome: AE - Acute Renal Failure      Population: All Participants
Time Point Measure Elective surgery


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N Analyzed 582
Counts 4
Percentage 0.7
Outcome: AE - Infection requiring Abx (CD II)      Population: All Participants
Time Point Measure Elective surgery


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N Analyzed 582
Counts 8
Percentage 1.4
Outcome: AE - Infection requiring Abx (CD II)      Population: All Participants
Time Point Measure Elective surgery


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N Analyzed 582
Counts 5
Percentage 1.8
Outcome: AE - Infection requiring Abx (CD II)      Population: All Participants
Time Point Measure Elective surgery


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N Analyzed 582
Counts 29
Percentage 5.0
Outcome: AE - Major pulmonary event (CD IV)      Population: All Participants
Time Point Measure Elective surgery


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N Analyzed 582
Counts 26
Percentage 4.5
Outcome: AE - Major pulmonary event (CD IV)      Population: All Participants
Time Point Measure Elective surgery


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N Analyzed 582
Counts 1
Percentage 0.2
Outcome: AE - DVT      Population: All Participants
Time Point Measure Elective surgery


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N Analyzed 582
Counts 4
Percentage 0.7
Outcome: AE - Major cardiac event (CD IV)      Population: All Participants
Time Point Measure Elective surgery


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N Analyzed 582
Counts 5
Percentage 0.9
Outcome: AE - Stroke (CD IV)      Population: All Participants
Time Point Measure Elective surgery


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N Analyzed 582
Counts 3
Percentage 0.5
Outcome: AE - Major pulmonary event (CD IV)      Population: All Participants
Time Point Measure Elective surgery


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N Analyzed 582
Counts 10
Percentage 1.7
Outcome: AE - Return to OR or unplanned procedure (CD III)      Population: All Participants
Time Point Measure Elective surgery


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N Analyzed 582
Counts 9
Percentage 1.5


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.
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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.