Study Preview
Study Title and Description
Uncomplicated diverticulitis, more complicated than we thought.
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 | Uncomplicated diverticulitis, more complicated than we thought. |
Author | XXXBoostrom SY., Wolff BG., Cima RR., Merchea A., Dozois EJ., Larson DW. |
Country | Division of Colon and Rectal Surgery, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USA. |
Year | 2012 |
Numbers |
Pubmed ID: 22696233 |
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 | Arm 1: Acute resolving uncomplicated diverticulitis | |
2 | Elective surgery | Arm2: Chronic/ smoldering uncomplicated diverticulitis | |
3 | Elective surgery | Arm3: Atypical uncomplicated diverticulitis |
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 | Not reported (or unclear) | ||
Study name | Mayo Clinic, Rochester | ||
Associated articles | |||
ClinicalTrials.gov identifier | |||
Start and end years of the Study | 2005 | ||
2009 | |||
Inclusion criteria | patients who underwent sigmoid resection for a diagnosis of diverticulitis | ||
Exclusion criteria | emergent resection | ||
if not an RCT, what was the directionality? | Retrospective | ||
Specific population? | No (all comers) | ||
Was diverticulitis diagnosed with CT? ... | Unclear/Multiple methods (explain) ... | ||
If NRCS, what analytic method was used to account for differences between study arms? | |||
How was diverticulitis diagnosed | Acute resolving uncomplicated diverticulitis is defined as discrete episodes of left lower quadrant abdominal pain, fever, leukocytosis, and evidence of inflammation on imaging that resolve with conservative management. Chronic/ smoldering uncomplicated diverticulitis is defined as symptoms of left lower quadrant abdominal pain and evidence of inflammation (elevated white blood cell count, fever, CT evidence of inflammation) that does not improve with the traditional antibiotic regimen, or re-exacerbation with cessation of antibiotics, for at least 3 months’ duration. Atypical uncomplicated diverticulitis is defined as symptoms of left lower quadrant pain and possible alterations in bowel habits for a period of at least 3 months; however, other clinical and radiographic evidence of diverticulitis is not present. | ||
Note/Comment about Design (or overall study) |
Baseline Characteristics
Question | Elective surgery | Elective surgery | Elective surgery | Total | Comments | ||||
---|---|---|---|---|---|---|---|---|---|
Answer | Follow-up | Answer | Follow-up | Answer | Follow-up | Answer | Follow-up | ||
Participant race/ethnicity characteristics | Male | 45 | Male | 38 | Male | 37 | |||
Participant Age - Continuous data (in years) | Median | 63 | Median | 66 | Median | 64 | |||
Participant Age - Categorical data | No data entered. | ||||||||
Participants with Un/Complicated Diverticulitis | No data entered. | ||||||||
Specific Complications of Diverticulitis | No data entered. | ||||||||
Number of Prior Episodes of Diverticulitis (categorical) | No data entered. | ||||||||
History of (Prior) Complicated Diverticulitis | No data entered. | ||||||||
KQ 4: Time Since Last Episode of Diverticulitis | No data entered. | ||||||||
Note/Comment about baseline characteristics | Duration of symptoms ranged from 3 months to 3 years (mean 7.5 months) | Duration of symptoms in the atypical group ranged from 3 months to 18 years (mean 21.9 months) | |||||||
Number of Prior Episodes of Diverticulitis (continuous) | Median | 3 | |||||||
Range | 1-15 |
Results & Comparisons
Results Data
Outcome: Diverticulitis-related morbidities Population: All Participants | ||||
---|---|---|---|---|
Time Point | Measure | Elective surgery | Elective surgery | Elective surgery |
30 days |
N Analyzed | 564 | 66 | 54 |
Counts | 199 | 22 | 26 | |
Percentage | 35.3 | 33.3 | 48.1 |
Outcome: AE - Return to OR or unplanned procedure (CD III) Population: All Participants | ||||
---|---|---|---|---|
Time Point | Measure | Elective surgery | Elective surgery | Elective surgery |
Enter a numeric value or title (required) years |
N Analyzed | 564 | 66 | 54 |
Counts | 8 | 0 | 1 | |
Percentage | 1.4 | 0 | 1.9 |
Outcome: AE - Bleed requiring transfusion (CD II) Population: All Participants | ||||
---|---|---|---|---|
Time Point | Measure | Elective surgery | Elective surgery | Elective surgery |
Enter a numeric value or title (required) years |
N Analyzed | 564 | 66 | 54 |
Counts | 28 | 1 | 0 | |
Percentage | 5.0 | 1.5 | 0 |
Outcome: AE - Acute Renal Failure Population: All Participants | ||||
---|---|---|---|---|
Time Point | Measure | Elective surgery | Elective surgery | Elective surgery |
Enter a numeric value or title (required) years |
N Analyzed | 564 | 66 | 54 |
Counts | 5 | 0 | 0 | |
Percentage | 0.9 | 0 | 0 |
Outcome: AE - Infection requiring Abx (CD II) Population: All Participants | ||||
---|---|---|---|---|
Time Point | Measure | Elective surgery | Elective surgery | Elective surgery |
Enter a numeric value or title (required) years |
N Analyzed | 564 | 66 | 54 |
Counts | 12 | 1 | 1 | |
Percentage | 2.1 | 1.5 | 1.9 |
Outcome: AE - Major cardiac event (CD IV) Population: All Participants | ||||
---|---|---|---|---|
Time Point | Measure | Elective surgery | Elective surgery | Elective surgery |
Enter a numeric value or title (required) years |
N Analyzed | 564 | 66 | 54 |
Counts | 9 | 2 | 2 | |
Percentage | 1.6 | 3.0 | 3.7 |
Outcome: AE - Stroke (CD IV) Population: All Participants | ||||
---|---|---|---|---|
Time Point | Measure | Elective surgery | Elective surgery | Elective surgery |
Enter a numeric value or title (required) years |
N Analyzed | 564 | 66 | 54 |
Counts | 2 | 0 | 0 | |
Percentage | 0.4 | 0 | 0 |
Outcome: AE - Major pulmonary event (CD IV) Population: All Participants | ||||
---|---|---|---|---|
Time Point | Measure | Elective surgery | Elective surgery | Elective surgery |
Enter a numeric value or title (required) years |
N Analyzed | 564 | 66 | 54 |
Counts | 8 | 0 | 0 | |
Percentage | 1.4 | 0 | 0 |
Outcome: AE - 30 day mortality (post-surgical, CD V) Population: All Participants | ||||
---|---|---|---|---|
Time Point | Measure | Elective surgery | Elective surgery | Elective surgery |
Enter a numeric value or title (required) years |
N Analyzed | 564 | 66 | 54 |
Counts | 2 | 0 | 0 | |
Percentage | 0.4 | 0 | 0 |
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 | Low | ||
Q22: Cochrane - Other Bias: Bias due to problems not covered elsewhere in the table. If yes, describe them in the Notes. | |||
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.