Study Preview
Study Title and Description
Outcomes of laparoscopic versus open colectomy in elective surgery for diverticulitis.
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 | Outcomes of laparoscopic versus open colectomy in elective surgery for diverticulitis. |
Author | Masoomi H., Buchberg B., Nguyen B., Tung V., Stamos MJ., Mills S. |
Country | Department of Surgery, University of California Irvine Medical Center, 333 City Boulevard West, Suite 850, Orange, CA 92868, USA. |
Year | 2011 |
Numbers |
Pubmed ID: 21732208 |
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 | Open surgery | |
2 | Elective surgery | Laparoscopy |
Question... Follow Up | Answer | Follow-up Answer | |
---|---|---|---|
Specific KQ | KQ 4c: Surgery (recur prev) | ||
KQ 4c: Surgery (recur prev) | |||
KQ 4c: Surgery (recur prev) | |||
KQ 4c: Surgery (recur prev) | |||
KQ 4c: Surgery (recur prev) | |||
KQ 4c: Surgery (recur prev) | |||
KQ 4c: Surgery (recur prev) | |||
Study Design | Other single group study (for harms only) | ||
Other single group study (for harms only) | |||
Other single group study (for harms only) | |||
Other single group study (for harms only) | |||
Other single group study (for harms only) | |||
Country | USA | ||
USA | |||
USA | |||
USA | |||
USA | |||
USA | |||
USA | |||
Funder | Non-industry (fully) | ||
Study name | Nationwide Inpatient Sample (2002-2007) | ||
Associated articles | Other studies: 18639223, 27422847 | ||
ClinicalTrials.gov identifier | |||
Start and end years of the Study | 2002 | ||
2007 | |||
Inclusion criteria | Hospitalizations resulting from elective colon resection were identified with ICD procedure code and then divided into open surgery and laparoscopy groups. | ||
Exclusion criteria | Urgent colon resection | ||
if not an RCT, what was the directionality? | Retrospective | ||
Specific population? | No (all comers) | ||
Was diverticulitis diagnosed with CT? ... | Unclear/Multiple methods (explain) ... | patients included using ICD codes for elective colon resections | |
If NRCS, what analytic method was used to account for differences between study arms? | |||
How was diverticulitis diagnosed | All discharges with International Classification of Disease (ICD) procedure codes [sigmoidectomy (45.76) or anterior resection (48.62, 48.63)] with a primary diagnosis of diverticulitis (codes 562.11 and 562.13) were selected from 2002 to 2007; those patients with the admission code for an elective operation were identified and utilized in the study. | ||
Note/Comment about Design (or overall study) |
Baseline Characteristics
Question | Elective surgery | Elective surgery | Total | Comments | |||
---|---|---|---|---|---|---|---|
Answer | Follow-up | Answer | Follow-up | Answer | Follow-up | ||
Participant race/ethnicity characteristics | Male | 47.1 | Male | 47.4 | |||
White | 89 | White | 84.9 | ||||
Black | 3.4 | Black | 3.7 | ||||
Hispanic/Latino | 4.9 | Hispanic/Latino | 8.8 | ||||
Asian | 0.3 | Asian | 0.1 | ||||
Participant Age - Continuous data (in years) | Mean | 57 | Mean | 55 | |||
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 | No data entered. | ||||||
Number of Prior Episodes of Diverticulitis (continuous) | No data entered. |
Results & Comparisons
Results Data
Outcome: Conversion to (or occurrence of) complicated diverticulitis Population: All Participants | |||
---|---|---|---|
Time Point | Measure | Elective surgery | Elective surgery |
Enter a numeric value or title (required) years |
N Analyzed | 110172 | 14562 |
Percentage | 1.15 | 0.63 |
Outcome: Conversion to (or occurrence of) complicated diverticulitis Population: All Participants | |||
---|---|---|---|
Time Point | Measure | Elective surgery | Elective surgery |
Enter a numeric value or title (required) years |
N Analyzed | 110172 | 14562 |
Percentage | 23.79 | 17.34 |
Outcome: Mortality - Diverticulitis-related Population: All Participants | |||
---|---|---|---|
Time Point | Measure | Elective surgery | Elective surgery |
Enter a numeric value or title (required) years |
N Analyzed | 110172 | 14562 |
Percentage | 0.54 | 0.13 |
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. | 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.