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Study Title and Description

Relationship Between Diverticular Disease and Incisional Hernia After Elective Colectomy: a Population-Based Study.



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 Relationship Between Diverticular Disease and Incisional Hernia After Elective Colectomy: a Population-Based Study.
Author Perez NP., Chang DC., Goldstone RN., Bordeianou L., Ricciardi R., Cavallaro PM.
Country Department of Surgery, Massachusetts General Hospital, 55 Fruit St, GRB-425, Boston, MA, 02114, USA. npperez@mgh.harvard.edu.
Year 2020
Numbers Pubmed ID: 32748338

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 Colectomy
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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 New York (NY) Statewide Planning and Research Cooperative System (SPARCS)
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Associated articles
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ClinicalTrials.gov identifier
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Start and end years of the Study 2010
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2016
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Inclusion criteria 18 years old and older, undergoing elective open or laparoscopic sigmoid or left hemicolectomy (by ICD-9 code) for diverticulitis (by ICD-9 code)
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Exclusion criteria index colectomy were excluded, as well as patients with colon cancer who had been noted to have diverticular disease at any point prior to their colectomy. prior abdominal surgeries, concurrent stoma creations, hernia repairs, or surgeries of the liver, spleen, pancreas, kidneys, or uterus during their index colectomy, abdominal operations during their index admission after their index colectomy, organ space abscess, anastomotic leak, or wound disruption/infection within 30 days after index colectomy; inflammatory bowel disease; chemotherapy within 6 months prior to or after index colectomy; radiation therapy any time prior to or within 6 months after index colectomy; history of rectal, anal, or prostate cancer; and history of congenital abdominal wall defect.
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Specific population? No (all comers)
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Was diverticulitis diagnosed with CT? ... Unclear/Multiple methods (explain) ... NR
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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)
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Baseline Characteristics
Question Elective surgery Total Comments
AnswerFollow-up AnswerFollow-up
Participant race/ethnicity characteristics Male 50.1
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White 81.7
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Black 3.9
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Hispanic/Latino 7.1
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Asian 0.4
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Participant Age - Continuous data (in years) Mean 55.9
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95% CI 55.6, 56.2
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Participant Age - Categorical data No data entered.
Participants with Un/Complicated Diverticulitis Not reported
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Specific Complications of Diverticulitis 100
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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) Not reported
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Results & Comparisons


Results Data
Outcome: AE - Return to OR or unplanned procedure (CD III)      Population: All Participants
Time Point Measure Elective surgery


1 years

N Analyzed 6811
Counts 129
Percentage 1.9


3 years

N Analyzed 6811
Counts 272
Percentage 4.0


5 years

N Analyzed 6811
Counts 334
Percentage 4.9


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
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Q21: Cochrane - Selective Reporting (reporting bias): Reporting bias due to selective outcome reporting
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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.