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Study Title and Description

Laparoscopic sigmoid colectomy for complicated diverticulitis is safe: review of 576 consecutive colectomies.



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 Laparoscopic sigmoid colectomy for complicated diverticulitis is safe: review of 576 consecutive colectomies.
Author Bhakta A., Tafen M., Glotzer O., Canete J., Chismark AD., Valerian BT., Stain SC., Lee EC.
Country Department of Surgery, Albany Medical College, 43 New Scotland Avenue, Mail Code MC-194, Albany, NY, 12208-3479, USA. bhaktaa@mail.amc.edu.
Year 2016
Numbers Pubmed ID: 26275534

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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Study Design Other single group study (for harms only)
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Country USA
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Funder Non-industry (fully)
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Study name Albany Medical Center 2001-13
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Associated articles
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ClinicalTrials.gov identifier
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Start and end years of the Study 2001
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2013
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Inclusion criteria diverticulitis requiring elective surgery
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Exclusion criteria none
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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? No imaging
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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 defined as either a physician-documented or self-reported episode of left lower quadrant abdominal pain and tenderness, with or without fever and leukocytosis.
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Note/Comment about Design (or overall study)
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Baseline Characteristics
Question Elective surgery Total Comments
AnswerFollow-up AnswerFollow-up
Participant race/ethnicity characteristics Male 47
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Participant Age - Continuous data (in years) Mean 55.7
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Participant Age - Categorical data No data entered.
Participants with Un/Complicated Diverticulitis Complicated diverticulitis 24.1
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Uncomplicated diverticulitis 75.9
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Specific Complications of Diverticulitis 8.3
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perforated diverticulitis
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0.7
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stricture
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3.6
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immunocompromised
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0.5
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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 Not reported
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Note/Comment about baseline characteristics No data entered.
Number of Prior Episodes of Diverticulitis (continuous) Mean 3.1
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Range 1, 12
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Results & Comparisons


Results Data
Outcome: AE - Infection requiring Abx (CD II)      Population: All Participants
Time Point Measure Elective surgery


mean 12 months

N Analyzed 576
Counts
Percentage 2.3
Outcome: AE - Infection requiring Abx (CD II)      Population: simple diverticulitis
Time Point Measure Elective surgery


mean 12 months

N Analyzed 437
Counts
Percentage 2.1
Outcome: AE - Infection requiring Abx (CD II)      Population: complicated diverticulitis
Time Point Measure Elective surgery


mean 12 months

N Analyzed 139
Counts
Percentage 3.6
Outcome: AE - Clostridioides difficile (C diff) infection      Population: All Participants
Time Point Measure Elective surgery


mean 12 months

N Analyzed 576
Counts
Percentage 3.0
Outcome: AE - Clostridioides difficile (C diff) infection      Population: simple diverticulitis
Time Point Measure Elective surgery


mean 12 months

N Analyzed 437
Counts
Percentage 2.9
Outcome: AE - Clostridioides difficile (C diff) infection      Population: complicated diverticulitis
Time Point Measure Elective surgery


mean 12 months

N Analyzed 139
Counts
Percentage 2.9
Outcome: AE - Return to OR or unplanned procedure (CD III)      Population: All Participants
Time Point Measure Elective surgery


mean 12 months

N Analyzed 576
Counts
Percentage 1.8
Outcome: AE - Return to OR or unplanned procedure (CD III)      Population: simple diverticulitis
Time Point Measure Elective surgery


mean 12 months

N Analyzed 437
Counts
Percentage 1.6
Outcome: AE - Return to OR or unplanned procedure (CD III)      Population: complicated diverticulitis
Time Point Measure Elective surgery


mean 12 months

N Analyzed 139
Counts
Percentage 2.9
Outcome: AE - Return to OR or unplanned procedure (CD III)      Population: All Participants
Time Point Measure Elective surgery


mean 12 months

N Analyzed 576
Counts
Percentage 2.1
Outcome: AE - Return to OR or unplanned procedure (CD III)      Population: simple diverticulitis
Time Point Measure Elective surgery


mean 12 months

N Analyzed 437
Counts
Percentage 2.3
Outcome: AE - Return to OR or unplanned procedure (CD III)      Population: complicated diverticulitis
Time Point Measure Elective surgery


mean 12 months

N Analyzed 139
Counts
Percentage 1.4
Outcome: AE - Ileus      Population: All Participants
Time Point Measure Elective surgery


mean 12 months

N Analyzed 576
Counts
Percentage 3.8
Outcome: AE - Ileus      Population: simple diverticulitis
Time Point Measure Elective surgery


mean 12 months

N Analyzed 437
Counts
Percentage 3.2
Outcome: AE - Ileus      Population: complicated diverticulitis
Time Point Measure Elective surgery


mean 12 months

N Analyzed 139
Counts
Percentage 8.6


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 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.