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Study Title and Description

Laparoscopic "fast-track" sigmoidectomy for diverticulitis disease in Germany. Results of a prospective quality assurance program.



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 "fast-track" sigmoidectomy for diverticulitis disease in Germany. Results of a prospective quality assurance program.
Author Tsilimparis N., Haase O., Wendling P., Kipfmüller K., Schmid M., Engemann R., Schwenk W.
Country Klinik für Allgemein-, Visceral-, Gefäss- und Thoraxchirurgie, Charité- Universitätsmedizin Berlin.
Year 2010
Numbers Pubmed ID: 20812161

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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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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Country Germany
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Germany
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Germany
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Funder Not reported (or unclear)
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Study name Fast-track Kolon II
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Associated articles
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ClinicalTrials.gov identifier
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Start and end years of the Study 2005
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2008
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Inclusion criteria all patients with elective laparoscopic sigma resection for diverticulitis
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Exclusion criteria emergency surgery within 24 hours of admission, ileus, perforation, <18 years old, pregnant
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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 NR
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Note/Comment about Design (or overall study) AEs not extracted: any cardiac, any pulmonary, any renal, any urogenital, any neurological/psychiatric, any catheter related, any thrombotic, subcutaneous wound healing disorder
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Baseline Characteristics
Question Elective surgery Total Comments
AnswerFollow-up AnswerFollow-up
Participant race/ethnicity characteristics Male 42
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Participant Age - Continuous data (in years) Mean 63
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Range 23, 91
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Participant Age - Categorical data <60
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42
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60-69
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33
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>69
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25
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Participants with Un/Complicated Diverticulitis Complicated diverticulitis 0
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Uncomplicated diverticulitis 100
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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 - 30 day mortality (post-surgical, CD V)      Population: All Participants
Time Point Measure Elective surgery


30 days

N Analyzed 846
Counts 2
Percentage 0.2
Outcome: AE - 30 day mortality (post-surgical, CD V)      Population: age <60
Time Point Measure Elective surgery


30 days

N Analyzed 358
Counts 0
Percentage 0
Outcome: AE - 30 day mortality (post-surgical, CD V)      Population: age 60-69
Time Point Measure Elective surgery


30 days

N Analyzed 277
Counts 0
Percentage 0
Outcome: AE - 30 day mortality (post-surgical, CD V)      Population: age >69
Time Point Measure Elective surgery


30 days

N Analyzed 211
Counts 2
Percentage 1
Outcome: Hospitalization (or re-hospitalization) for diverticulitis (avoidance)      Population: All Participants
Time Point Measure Elective surgery


30 days

N Analyzed 846
Counts 33
Percentage 3.9
note P-value for trend across age groups 0.81
Outcome: Hospitalization (or re-hospitalization) for diverticulitis (avoidance)      Population: age <60
Time Point Measure Elective surgery


30 days

N Analyzed 358
Counts 15
Percentage 4.2
Outcome: Hospitalization (or re-hospitalization) for diverticulitis (avoidance)      Population: age 60-69
Time Point Measure Elective surgery


30 days

N Analyzed 277
Counts 9
Percentage 3.3
Outcome: Hospitalization (or re-hospitalization) for diverticulitis (avoidance)      Population: age >69
Time Point Measure Elective surgery


30 days

N Analyzed 211
Counts 9
Percentage 4.3
Outcome: AE - Return to OR or unplanned procedure (CD III)      Population: All Participants
Time Point Measure Elective surgery


NR years

N Analyzed 846
Counts 17
Percentage 2
note P-value across age groups 0.605
Outcome: AE - Return to OR or unplanned procedure (CD III)      Population: age <60
Time Point Measure Elective surgery


NR years

N Analyzed 358
Counts 6
Percentage 1.7
note
Outcome: AE - Return to OR or unplanned procedure (CD III)      Population: age 60-69
Time Point Measure Elective surgery


NR years

N Analyzed 277
Counts 5
Percentage 1.8
note
Outcome: AE - Return to OR or unplanned procedure (CD III)      Population: age >69
Time Point Measure Elective surgery


NR years

N Analyzed 211
Counts 6
Percentage 2.8
note
Outcome: AE - Return to OR or unplanned procedure (CD III)      Population: All Participants
Time Point Measure Elective surgery


NR years

N Analyzed 846
Counts 7
Percentage 0.8
note P-value across age groups 0.042
Outcome: AE - Return to OR or unplanned procedure (CD III)      Population: age <60
Time Point Measure Elective surgery


NR years

N Analyzed 358
Counts 6
Percentage 1.7
note
Outcome: AE - Return to OR or unplanned procedure (CD III)      Population: age 60-69
Time Point Measure Elective surgery


NR years

N Analyzed 277
Counts 1
Percentage 0.4
note
Outcome: AE - Return to OR or unplanned procedure (CD III)      Population: age >69
Time Point Measure Elective surgery


NR years

N Analyzed 211
Counts 0
Percentage 0
note
Outcome: AE - Bleed requiring transfusion (CD II)      Population: All Participants
Time Point Measure Elective surgery


NR years

N Analyzed 846
Counts 6
Percentage 0.7
note P-value across age groups 0.06
Outcome: AE - Bleed requiring transfusion (CD II)      Population: age <60
Time Point Measure Elective surgery


NR years

N Analyzed 358
Counts 2
Percentage 0.6
note
Outcome: AE - Bleed requiring transfusion (CD II)      Population: age 60-69
Time Point Measure Elective surgery


NR years

N Analyzed 277
Counts 0
Percentage 0
note
Outcome: AE - Bleed requiring transfusion (CD II)      Population: age >69
Time Point Measure Elective surgery


NR years

N Analyzed 211
Counts 4
Percentage 1.9
note
Outcome: AE - Ileus      Population: All Participants
Time Point Measure Elective surgery


NR years

N Analyzed 846
Counts 5
Percentage 0.6
note
Outcome: AE - Ileus      Population: age <60
Time Point Measure Elective surgery


NR years

N Analyzed 358
Counts 0
Percentage 0
note
Outcome: AE - Ileus      Population: age 60-69
Time Point Measure Elective surgery


NR years

N Analyzed 277
Counts 3
Percentage 1.1
note
Outcome: AE - Ileus      Population: age >69
Time Point Measure Elective surgery


NR years

N Analyzed 211
Counts 2
Percentage 1
note P across subgroups 0.155
Outcome: AE - Ileus      Population: All Participants
Time Point Measure Elective surgery


NR years

N Analyzed 846
Counts 2
Percentage 0.2
note
Outcome: AE - Ileus      Population: age <60
Time Point Measure Elective surgery


NR years

N Analyzed 358
Counts 0
Percentage 0
note
Outcome: AE - Ileus      Population: age 60-69
Time Point Measure Elective surgery


NR years

N Analyzed 277
Counts 0
Percentage 0
note
Outcome: AE - Ileus      Population: age >69
Time Point Measure Elective surgery


NR years

N Analyzed 211
Counts 2
Percentage 1
note P across subgroups 0.05


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.