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Study Title and Description

Is there anything we can modify among factors associated with morbidity following elective laparoscopic sigmoidectomy 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 Is there anything we can modify among factors associated with morbidity following elective laparoscopic sigmoidectomy for diverticulitis?
Author Silva-Velazco J., Stocchi L., Costedio M., Gorgun E., Kessler H., Remzi FH.
Country Department of Colorectal Surgery, Digestive Disease Institute, Cleveland Clinic, 9500 Euclid Ave/A30, Cleveland, OH, 44195, USA.
Year 2016
Numbers Pubmed ID: 26541732

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
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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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Study Design 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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Funder Non-industry (fully)
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Study name
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Associated articles
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ClinicalTrials.gov identifier
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Start and end years of the Study 1992
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2013
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Inclusion criteria elective, restorative procedures for sigmoid diverticulitis performed using a minimally invasive approach
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Exclusion criteria disease presentations requiring urgent surgery
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if not an RCT, what was the directionality? Prospective
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Specific population? No (all comers)
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Was diverticulitis diagnosed with CT? CT
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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 diverticulitis was radiologically confirmed in 1032 patients (97.5 %), while outside preoperative imaging was not available in our institutional records in the remaining 27 patients
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Note/Comment about Design (or overall study) subgroups not extracted: ASA1; ASA 3; ASA 4; Conversion to open; Steroid use; Rectal transection technique; Linear stapler under direct vision; Knife transection; Operative experience (C20 cases); Operative time (per 30-min increments); Loop ileostomy creation
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Baseline Characteristics
Question Elective surgery Total Comments
AnswerFollow-up AnswerFollow-up
Participant race/ethnicity characteristics Male 52
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Participant Age - Continuous data (in years) Mean 55
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SD 12
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Participant Age - Categorical data No data entered.
Participants with Un/Complicated Diverticulitis Complicated diverticulitis 27
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Specific Complications of Diverticulitis Preoperative percutaneous abscess drainage
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6
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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 6-8 weeks
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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 - Unplanned (re)hospitalization (CD IV)      Population: All Participants
Time Point Measure Elective surgery


30 days

N Analyzed 1059
Counts 120
Percentage 11
Outcome: AE - 30 day mortality (post-surgical, CD V)      Population: All Participants
Time Point Measure Elective surgery


30 days

N Analyzed 1059
Counts 2
Percentage 0.19
Outcome: AE - Serious (SAE)      Population: All Participants
Time Point Measure Elective surgery


30 days

N Analyzed 1059
Counts 296
Percentage 28
note
Outcome: AE - Serious (SAE)      Population: BMI 30-35
Time Point Measure Elective surgery


30 days

N Analyzed 1059
note vs BMI<30: OR 1.31 (95% CI 0.93, 1.84) P=0.12
Outcome: AE - Serious (SAE)      Population: BMI >= 35
Time Point Measure Elective surgery


30 days

N Analyzed 1059
note vs BMI<30: OR 1.05 (95% CI 0.68, 1.60) P=0.84
Outcome: AE - Serious (SAE)      Population: Complicated diverticulitis
Time Point Measure Elective surgery


30 days

N Analyzed 1059
note vs. uncomplicated diverticulitis OR 1.32 (95% CI 0.96, 1.82) P=0.08
Outcome: AE - Return to OR or unplanned procedure (CD III)      Population: All Participants
Time Point Measure Elective surgery


30 days

N Analyzed 1059
Counts
Percentage 3.7
Outcome: AE - Return to OR or unplanned procedure (CD III)      Population: BMI 30-35
Time Point Measure Elective surgery


30 days

N Analyzed 1059
note vs BMI<30: OR 1.33 (95% CI 0.69, 2.55) P=0.39
Outcome: AE - Return to OR or unplanned procedure (CD III)      Population: BMI >= 35
Time Point Measure Elective surgery


30 days

N Analyzed 1059
note vs BMI<30: OR 2.30 (95% CI 1.16, 4.55) P=0.017
Outcome: AE - Return to OR or unplanned procedure (CD III)      Population: Complicated diverticulitis
Time Point Measure Elective surgery


30 days

N Analyzed 1059
note vs uncomplicated diverticulitis: OR 2.37 (95% CI 1.36, 4.11) P=0.002
Outcome: AE - Return to OR or unplanned procedure (CD III)      Population: All Participants
Time Point Measure Elective surgery


30 days

N Analyzed 1059
Counts 64
Percentage 6


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 Unclear Lumping of AE outcomes into a single outcome could be problematic
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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.