Advanced Search

Study Preview



Study Title and Description

Multicentre study of non-surgical management of diverticulitis with abscess formation.



Key Questions Addressed
2 KEY QUESTION 2 KQ 2: What are the benefits and harms of various treatment options for the treatment of acute diverticulitis? KQ 2a. For patients with acute uncomplicated diverticulitis, what are the effectiveness and harms of hospitalization versus outpatient management of the acute episode? • Do the effects and harms vary by patient characteristics, presentation or course of illness, or other factors? KQ 2b. For patients with acute uncomplicated or complicated diverticulitis, what are the effects, comparative effects, and harms of antibiotics? • Do the effects and harms vary between patients with complicated or uncomplicated diverticulitis? • Do the (comparative) effects and harms vary by route of administration of antibiotics, type of antibiotic, and duration of course of antibiotics? • Do the (comparative) effects and harms vary by patient characteristics, presentation or course of illness, or other factors? KQ 2c. For patients with acute complicated diverticulitis, what are the effects and harms of interventional radiology procedures compared with conservative management? • Do the effects and harms vary by patient characteristics, presentation or course of illness, or other factors?
  • Comments Comments (
    0
    ) |

Primary Publication Information
  • Comments Comments (
    0
    ) |
TitleData
Title Multicentre study of non-surgical management of diverticulitis with abscess formation.
Author Lambrichts DPV., Bolkenstein HE., van der Does DCHE., Dieleman D., Crolla RMPH., Dekker JWT., van Duijvendijk P., Gerhards MF., Nienhuijs SW., Menon AG., de Graaf EJR., Consten ECJ., Draaisma WA., Broeders IAMJ., Bemelman WA., Lange JF.
Country Department of Surgery, Erasmus Medical Centre, Rotterdam, the Netherlands.
Year 2019
Numbers Pubmed ID: 30811050

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 IR: Percutaneous drainage
  • Comments Comments (
    0
    ) |
2 IR: No percutaneous drainage
  • Comments Comments (
    0
    ) |

Design Details
Question... Follow Up Answer Follow-up Answer
Specific KQ KQ 2c: Interventional radiology (acute)
  • Comments Comments (
    0
    ) |
KQ 2c: Interventional radiology (acute)
  • Comments Comments (
    0
    ) |
KQ 2c: Interventional radiology (acute)
  • Comments Comments (
    0
    ) |
Study Design Nonrandomized comparative study (NRCS)
  • Comments Comments (
    0
    ) |
Nonrandomized comparative study (NRCS)
  • Comments Comments (
    0
    ) |
Nonrandomized comparative study (NRCS)
  • Comments Comments (
    0
    ) |
Country ... Specify Other ... Netherlands
  • Comments Comments (
    0
    ) |
Funder Not reported (or unclear)
  • Comments Comments (
    0
    ) |
Study name Erasmus Medical Centre, Rotterdam and Academic Medical Centre, Amsterdam
  • Comments Comments (
    0
    ) |
Associated articles
  • Comments Comments (
    0
    ) |
ClinicalTrials.gov identifier
  • Comments Comments (
    0
    ) |
Start and end years of the Study 2008
  • Comments Comments (
    0
    ) |
2015
  • Comments Comments (
    0
    ) |
Inclusion criteria first episode of Complicated diverticulitis with abscess (Hinchey 1b or II)
  • Comments Comments (
    0
    ) |
Exclusion criteria perforated diverticulitis with peritonitis (Hinchey III or IV), signs of sepsis or concurrent fistula formation
  • Comments Comments (
    0
    ) |
if not an RCT, what was the directionality? Retrospective
  • Comments Comments (
    0
    ) |
Was diverticulitis diagnosed with CT? CT
  • Comments Comments (
    0
    ) |
If NRCS, what analytic method was used to account for differences between study arms? Multivariable logistic regression
  • Comments Comments (
    0
    ) |
How was diverticulitis diagnosed CT
  • Comments Comments (
    0
    ) |
Note/Comment about Design (or overall study)
  • Comments Comments (
    0
    ) |


Baseline Characteristics
Question IR: Percutaneous drainage IR: No percutaneous drainage Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant race/ethnicity characteristics Male 62.6 Male 58.1 Male 59.3
  • Comments Comments (
    0
    ) |
Participant Age - Continuous data (in years) Mean 63 Mean 60 Mean 61
  • Comments Comments (
    0
    ) |
SD 13 SD 13 SD 13
  • Comments Comments (
    0
    ) |
Participant Age - Categorical data No data entered.
Participants with Un/Complicated Diverticulitis Complicated diverticulitis 100 Complicated diverticulitis 100 Complicated diverticulitis 100
  • Comments Comments (
    0
    ) |
Specific Complications of Diverticulitis NR NR NR
  • Comments Comments (
    0
    ) |
100 100 100
  • Comments Comments (
    0
    ) |
Number of Prior Episodes of Diverticulitis (categorical) Other_1 (include definition in %) At least 1 = 38.3% Other_1 (include definition in %) At least 1 = 28.0% Other_1 (include definition in %) At least 1 = 30.6%
  • Comments Comments (
    0
    ) |
History of (Prior) Complicated Diverticulitis Not reported Not reported Not reported
  • Comments Comments (
    0
    ) |
KQ 4: Time Since Last Episode of Diverticulitis Not reported Not reported Not reported
  • Comments Comments (
    0
    ) |
Note/Comment about baseline characteristics No data entered.
Number of Prior Episodes of Diverticulitis (continuous) No data entered.



Results & Comparisons


Results Data
Adj. Odds Ratio (OR) Adj. 95% CI low Adj. 95% CI high Adj. P-Value
Outcome: Treatment failure      Population: All Participants Between-Arm Comparisons
Time Point Measure IR: Percutaneous drainage IR: No percutaneous drainage Comparison Measure IR: Percutaneous drainage vs. IR: No percutaneous drainage


30 days

N Analyzed 115 332 1.47
Counts 41 79 0.81
Percentage 35.7 23.8 2.68
0.185
Adj. Odds Ratio (OR) Adj. 95% CI low Adj. 95% CI high Adj. P-Value
Outcome: Treatment failure      Population: Hinchey Ib Between-Arm Comparisons
Time Point Measure IR: Percutaneous drainage IR: No percutaneous drainage Comparison Measure IR: Percutaneous drainage vs. IR: No percutaneous drainage


30 days

N Analyzed 18 197
Counts 6 44
Percentage 33.3 22.3
0.359
Adj. Odds Ratio (OR) Adj. 95% CI low Adj. 95% CI high Adj. P-Value
Outcome: Treatment failure      Population: Hinchey II Between-Arm Comparisons
Time Point Measure IR: Percutaneous drainage IR: No percutaneous drainage Comparison Measure IR: Percutaneous drainage vs. IR: No percutaneous drainage


30 days

N Analyzed 97 135
Counts 35 35
Percentage 36 25.9
0.149
Adj. Odds Ratio (OR) Adj. 95% CI low Adj. 95% CI high Adj. P-Value Adj. Odds Ratio (OR) Adj. 95% CI low Adj. 95% CI high Adj. P-Value
Outcome: Mortality - All-cause (non-AE)      Population: All Participants Between-Arm Comparisons
Time Point Measure IR: Percutaneous drainage IR: No percutaneous drainage Comparison Measure IR: Percutaneous drainage vs. IR: No percutaneous drainage


30 days

N Analyzed 115 332
Counts 2 3
Percentage 1.7 0.9
0.607


6 years

N Analyzed 115 332
Counts 12 16
Percentage 10.4 4.8
0.048
Adj. Odds Ratio (OR) Adj. 95% CI low Adj. 95% CI high Adj. P-Value Adj. Odds Ratio (OR) Adj. 95% CI low Adj. 95% CI high Adj. P-Value
Outcome: Mortality - All-cause (non-AE)      Population: Hinchey Ib Between-Arm Comparisons
Time Point Measure IR: Percutaneous drainage IR: No percutaneous drainage Comparison Measure IR: Percutaneous drainage vs. IR: No percutaneous drainage


30 days

N Analyzed 18 197
Counts 0 3
Percentage 0 1.5
1.00


6 years

N Analyzed 18 197
Counts 2 8
Percentage 1 4.1
0.263
Adj. Odds Ratio (OR) Adj. 95% CI low Adj. 95% CI high Adj. P-Value Adj. Odds Ratio (OR) Adj. 95% CI low Adj. 95% CI high Adj. P-Value
Outcome: Mortality - All-cause (non-AE)      Population: Hinchey II Between-Arm Comparisons
Time Point Measure IR: Percutaneous drainage IR: No percutaneous drainage Comparison Measure IR: Percutaneous drainage vs. IR: No percutaneous drainage


30 days

N Analyzed 97 135
Counts 2 0
Percentage 2 0
0.332


6 years

N Analyzed 97 135
Counts 10 8
Percentage 10 5.9
0.270
Adj. Odds Ratio (OR) Adj. 95% CI low Adj. 95% CI high Adj. P-Value Adj. Odds Ratio (OR) Adj. 95% CI low Adj. 95% CI high Adj. P-Value
Outcome: Surgery for diverticulitis, including colostomy (avoidance)      Population: All Participants Between-Arm Comparisons
Time Point Measure IR: Percutaneous drainage IR: No percutaneous drainage Comparison Measure IR: Percutaneous drainage vs. IR: No percutaneous drainage


30 days

N Analyzed 115 332 1.29
Counts 16 24 0.56
Percentage 13.9 7.2 2.99
0.554


6 years

N Analyzed 115 332 1.08
Counts 37 87 0.69
Percentage 32.2 26.2 1.69
0.736
Adj. Odds Ratio (OR) Adj. 95% CI low Adj. 95% CI high Adj. P-Value Adj. Odds Ratio (OR) Adj. 95% CI low Adj. 95% CI high Adj. P-Value
Outcome: Surgery for diverticulitis, including colostomy (avoidance)      Population: Hinchey Ib Between-Arm Comparisons
Time Point Measure IR: Percutaneous drainage IR: No percutaneous drainage Comparison Measure IR: Percutaneous drainage vs. IR: No percutaneous drainage


30 days

N Analyzed 18 197
Counts 1 10
Percentage 6 5.1
0.693


6 years

N Analyzed 18 197
Counts 6 57
Percentage 33.3 28.9
0.474
Adj. Odds Ratio (OR) Adj. 95% CI low Adj. 95% CI high Adj. P-Value Adj. Odds Ratio (OR) Adj. 95% CI low Adj. 95% CI high Adj. P-Value
Outcome: Surgery for diverticulitis, including colostomy (avoidance)      Population: Hinchey II Between-Arm Comparisons
Time Point Measure IR: Percutaneous drainage IR: No percutaneous drainage Comparison Measure IR: Percutaneous drainage vs. IR: No percutaneous drainage


30 days

N Analyzed 97 135
Counts 15 14
Percentage 15 10.4
0.117


6 years

N Analyzed 97 135
Counts 31 30
Percentage 32 22.2
0.046


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
  • Comments Comments (
    0
    ) |
Q15: Cochrane - Allocation concealment (selection bias): Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
  • Comments Comments (
    0
    ) |
Q16: Cochrane - Blinding of participants (performance bias): Performance bias due to knowledge of the allocated interventions by participants during the study High
  • Comments Comments (
    0
    ) |
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. High
  • Comments Comments (
    0
    ) |
Q18: Cochrane - FOR OBJECTIVE OUTCOMES - Blinding of outcome assessor (detection bias): Detection bias due to knowledge of the allocated interventions by outcome assessors. Unsure Not clear who performed the outcome assessment and whether they were blinded.
  • Comments Comments (
    0
    ) |
Q20: Cochrane - Incomplete outcome data (attrition bias): Attrition bias due to amount, nature or handling of incomplete outcome data Low No missing data on outcomes
  • Comments Comments (
    0
    ) |
Q21: Cochrane - Selective Reporting (reporting bias): Reporting bias due to selective outcome reporting Unclear
  • Comments Comments (
    0
    ) |
Q22: Cochrane - Other Bias: Bias due to problems not covered elsewhere in the table. If yes, describe them in the Notes. Low
  • Comments Comments (
    0
    ) |
Q1: ROBINS-I 1.1 Is there potential for confounding of the effect of intervention in this study? Yes
  • Comments Comments (
    0
    ) |
Q3: ROBINS-I 1.4. Did the authors use an appropriate analysis method that controlled for all the important confounding domains? Yes Multiple regression
  • Comments Comments (
    0
    ) |
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? Not Applicable
  • Comments Comments (
    0
    ) |
Q5: ROBINS-I 1.6. Did the authors control for any post-intervention variables that could have been affected by the intervention? Not Applicable
  • Comments Comments (
    0
    ) |
Q6: ROBINS-I - Risk of bias judgement for BIAS DUE TO CONFOUNDING Low
  • Comments Comments (
    0
    ) |
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? No
  • Comments Comments (
    0
    ) |
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? No
  • Comments Comments (
    0
    ) |
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? No
  • Comments Comments (
    0
    ) |
Q10: ROBINS-I 2.4. Do start of follow-up and start of intervention coincide for most participants? Yes
  • Comments Comments (
    0
    ) |
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? Not Applicable
  • Comments Comments (
    0
    ) |
Q13: ROBINS-I - Risk of bias judgement for BIAS IN SELECTION OF PARTICIPANTS INTO THE STUDY Low
  • Comments Comments (
    0
    ) |
Q2: Did the study divide the follow up time of each individual participant into the different interventions? No
  • Comments Comments (
    0
    ) |
Q11: Did the start and follow up calendar years coincide for most participants in the study? Yes
  • Comments Comments (
    0
    ) |
Q19: Cochrane - FOR SUBJECTIVE OUTCOMES - Blinding of outcome assessor (detection bias): Detection bias due to knowledge of the allocated interventions by outcome assessors. Unsure Not clear who performed the outcome assessment and whether they were blinded.
  • Comments Comments (
    0
    ) |
Q23: NHLBI - Were eligibility/selection criteria for the study population prespecified and clearly described? Yes
  • Comments Comments (
    0
    ) |
Q24: NHLBI - Was the test/service/intervention clearly described and delivered consistently across the study population? Yes
  • Comments Comments (
    0
    ) |
Q25: NHLBI - Were the outcome measures prespecified, clearly defined, valid, reliable, and assessed consistently across all study participants? Yes
  • Comments Comments (
    0
    ) |

Quality Rating
Guideline Used Overall Rating