Study Preview
Study Title and Description
The impact of delaying elective resection of diverticulitis on laparoscopic conversion rate.
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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Comments (0) | - Post/View
| Title | The impact of delaying elective resection of diverticulitis on laparoscopic conversion rate. |
| Author | Simianu V, Sinanan M, Bastawrous A, Billingham R, Fichera A, Florence M, Herzig D, Johnson E, Steele S, Thirlby R, Flum D |
| Country | SCOAP-CERTAIN Collaborative |
| Year | 2015 |
| Numbers |
Pubmed ID: 25773308 |
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 |
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| 1 | Elective surgery |
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| Question... Follow Up | Answer | Follow-up Answer | |
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| 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 | Surgical Care and Outcomes Assessment Program (SCOAP) |
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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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| 2013 |
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| Inclusion criteria | underwent laparoscopic colon resection for diverticulitis |
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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? ... | Unclear/Multiple methods (explain) ... | not reported |
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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 | ||
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| Answer | Follow-up | Answer | Follow-up | ||
| Participant race/ethnicity characteristics | Male | 47 |
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| White | 87.2 |
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| Participant Age - Continuous data (in years) | Mean | 57.8 |
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| SD | 12.7 |
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| Participant Age - Categorical data | No data entered. | ||||
| Participants with Un/Complicated Diverticulitis | Not reported | 100 |
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| Specific Complications of Diverticulitis | Colovesicular fistula |
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| 8.7 |
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| Current GI bleed |
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| 2.3 |
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| Stricture |
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| 4.4 |
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| Other fistula |
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| 3.8 |
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| Number of Prior Episodes of Diverticulitis (categorical) | 0 | 13.9 |
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| 1 | 15.2 |
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| 2 | 14.5 |
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| >=3 | 52.5 (3-10) |
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| Other_1 (include definition in %) | 4.0 (>10) |
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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 - Serious (SAE) Population: All Participants | ||
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| Time Point | Measure | Elective surgery |
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30 days |
N Analyzed | 1790 |
| Counts | 139 | |
| Percentage | 7.8 | |
| Outcome: AE - Return to OR or unplanned procedure (CD III) Population: All Participants | ||
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| Time Point | Measure | Elective surgery |
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30 days |
N Analyzed | 1790 |
| Counts | 210 | |
| Percentage | 11.7 | |
Quality Dimensions
| Dimension | Value | Notes | Comments |
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| 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 | other | 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.
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