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? |
Primary Publication Information
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 |
---|---|---|---|
1 | Elective surgery |
Question... Follow Up | Answer | Follow-up Answer | |
---|---|---|---|
Specific KQ | KQ 4c: Surgery (recur prev) | ||
Study Design | Other single group study (for harms only) | ||
Country | USA | ||
Funder | Non-industry (fully) | ||
Study name | Surgical Care and Outcomes Assessment Program (SCOAP) | ||
Associated articles | |||
ClinicalTrials.gov identifier | |||
Start and end years of the Study | 2010 | ||
2013 | |||
Inclusion criteria | underwent laparoscopic colon resection for diverticulitis | ||
Exclusion criteria | none | ||
if not an RCT, what was the directionality? | Prospective | ||
Specific population? | No (all comers) | ||
Was diverticulitis diagnosed with CT? ... | Unclear/Multiple methods (explain) ... | not reported | |
If NRCS, what analytic method was used to account for differences between study arms? | |||
How was diverticulitis diagnosed | NR | ||
Note/Comment about Design (or overall study) |
Baseline Characteristics
Question | Elective surgery | Total | Comments | ||
---|---|---|---|---|---|
Answer | Follow-up | Answer | Follow-up | ||
Participant race/ethnicity characteristics | Male | 47 | |||
White | 87.2 | ||||
Participant Age - Continuous data (in years) | Mean | 57.8 | |||
SD | 12.7 | ||||
Participant Age - Categorical data | No data entered. | ||||
Participants with Un/Complicated Diverticulitis | Not reported | 100 | |||
Specific Complications of Diverticulitis | Colovesicular fistula | ||||
8.7 | |||||
Current GI bleed | |||||
2.3 | |||||
Stricture | |||||
4.4 | |||||
Other fistula | |||||
3.8 | |||||
Number of Prior Episodes of Diverticulitis (categorical) | 0 | 13.9 | |||
1 | 15.2 | ||||
2 | 14.5 | ||||
>=3 | 52.5 (3-10) | ||||
Other_1 (include definition in %) | 4.0 (>10) | ||||
History of (Prior) Complicated Diverticulitis | Not reported | ||||
KQ 4: Time Since Last Episode of Diverticulitis | Not reported | ||||
Note/Comment about baseline characteristics | No data entered. | ||||
Number of Prior Episodes of Diverticulitis (continuous) | Not reported |
Results & Comparisons
Results Data
Outcome: AE - Serious (SAE) Population: All Participants | ||
---|---|---|
Time Point | Measure | Elective surgery |
30 days |
N Analyzed | 1790 |
Counts | 139 | |
Percentage | 7.8 |
Outcome: AE - Return to OR or unplanned procedure (CD III) Population: All Participants | ||
---|---|---|
Time Point | Measure | Elective surgery |
30 days |
N Analyzed | 1790 |
Counts | 210 | |
Percentage | 11.7 |
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 | |||
Q15: Cochrane - Allocation concealment (selection bias): Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment | |||
Q16: Cochrane - Blinding of participants (performance bias): Performance bias due to knowledge of the allocated interventions by participants during the study | |||
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. | |||
Q18: Cochrane - FOR OBJECTIVE OUTCOMES - Blinding of outcome assessor (detection bias): Detection bias due to knowledge of the allocated interventions by outcome assessors. | |||
Q20: Cochrane - Incomplete outcome data (attrition bias): Attrition bias due to amount, nature or handling of incomplete outcome data | Low | ||
Q21: Cochrane - Selective Reporting (reporting bias): Reporting bias due to selective outcome reporting | other | Low | |
Q22: Cochrane - Other Bias: Bias due to problems not covered elsewhere in the table. If yes, describe them in the Notes. | Low | ||
Q1: ROBINS-I 1.1 Is there potential for confounding of the effect of intervention in this study? | |||
Q3: ROBINS-I 1.4. Did the authors use an appropriate analysis method that controlled for all the important confounding domains? | |||
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? | |||
Q5: ROBINS-I 1.6. Did the authors control for any post-intervention variables that could have been affected by the intervention? | |||
Q6: ROBINS-I - Risk of bias judgement for BIAS DUE TO CONFOUNDING | |||
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? | |||
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? | |||
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? | |||
Q10: ROBINS-I 2.4. Do start of follow-up and start of intervention coincide for most participants? | |||
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? | |||
Q13: ROBINS-I - Risk of bias judgement for BIAS IN SELECTION OF PARTICIPANTS INTO THE STUDY | |||
Q2: Did the study divide the follow up time of each individual participant into the different interventions? | |||
Q11: Did the start and follow up calendar years coincide for most participants in the study? | |||
Q19: Cochrane - FOR SUBJECTIVE OUTCOMES - Blinding of outcome assessor (detection bias): Detection bias due to knowledge of the allocated interventions by outcome assessors. | |||
Q23: NHLBI - Were eligibility/selection criteria for the study population prespecified and clearly described? | Yes | ||
Q24: NHLBI - Was the test/service/intervention clearly described and delivered consistently across the study population? | Yes | ||
Q25: NHLBI - Were the outcome measures prespecified, clearly defined, valid, reliable, and assessed consistently across all study participants? | Yes |
Quality Rating
No quality rating data was found.