Advanced Search

Study Preview



Study Title and Description

Randomized clinical trial of elective resection versus observation in diverticulitis with extraluminal air or abscess initially managed conservatively



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?
  • Comments Comments (
    0
    ) |

Primary Publication Information
  • Comments Comments (
    0
    ) |
TitleData
Title Randomized clinical trial of elective resection versus observation in diverticulitis with extraluminal air or abscess initially managed conservatively
Author You K.
Country Division of Colon and Rectal Surgery, State University of New York, Stony Brook, New York, USA
Year 2018
Numbers Pubmed ID: 29683483

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 Placebo Observation
  • Comments Comments (
    0
    ) |
2 Elective surgery
  • Comments Comments (
    0
    ) |

Design Details
Question... Follow Up Answer Follow-up Answer
Specific KQ KQ 4b: Non-Pharmacologic (recur prev)
  • Comments Comments (
    0
    ) |
KQ 4c: Surgery (recur prev)
  • Comments Comments (
    0
    ) |
Study Design RCT
  • Comments Comments (
    0
    ) |
Country USA
  • Comments Comments (
    0
    ) |
Funder Industry (fully or in part)
  • Comments Comments (
    0
    ) |
Study name
  • Comments Comments (
    0
    ) |
Associated articles
  • Comments Comments (
    0
    ) |
ClinicalTrials.gov identifier NCT 01986686
  • Comments Comments (
    0
    ) |
Start and end years of the Study 2011
  • Comments Comments (
    0
    ) |
2016
  • Comments Comments (
    0
    ) |
Inclusion criteria >=18 with a first episode of acute diverticulitis of the sigmoid colon complicated by extraluminal air with or without abscess, first treated with successful non-operative management and colonoscopy negative for malignancy.
  • Comments Comments (
    0
    ) |
Exclusion criteria history of previous diverticulitis of the sigmoid colon; history of diverticulitis of the sigmoid colon, colonic cancer at colonoscopy, immunosuppression, acute diverticulitis of the sigmoid colon complicated by peritonitis and/or distant free air, pregnancy, or inability to sign informed consent.
  • Comments Comments (
    0
    ) |
Specific population? No (all comers)
  • 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?
  • Comments Comments (
    0
    ) |
How was diverticulitis diagnosed Not explicitly described
  • Comments Comments (
    0
    ) |
Note/Comment about Design (or overall study)
  • Comments Comments (
    0
    ) |


Baseline Characteristics
Question Placebo Elective surgery Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant race/ethnicity characteristics Male 63 Male 54
  • Comments Comments (
    0
    ) |
Participant Age - Continuous data (in years) Mean 55.2 Mean 53.3
  • Comments Comments (
    0
    ) |
SD 13.1 SD 13.5
  • Comments Comments (
    0
    ) |
Participant Age - Categorical data No data entered.
Participants with Un/Complicated Diverticulitis Not reported 100 Not reported 1oo
  • Comments Comments (
    0
    ) |
Specific Complications of Diverticulitis Abscess Abscess
  • Comments Comments (
    0
    ) |
42 58
  • Comments Comments (
    0
    ) |
Extraluminal air Extraluminal air
  • Comments Comments (
    0
    ) |
100 100
  • Comments Comments (
    0
    ) |
Number of Prior Episodes of Diverticulitis (categorical) 0 recurrent excluded 0 recurrent excluded
  • Comments Comments (
    0
    ) |
History of (Prior) Complicated Diverticulitis Not reported Not reported
  • Comments Comments (
    0
    ) |
KQ 4: Time Since Last Episode of Diverticulitis Not reported Not reported
  • Comments Comments (
    0
    ) |
Note/Comment about baseline characteristics No data entered.
Number of Prior Episodes of Diverticulitis (continuous) Mean 0 Mean 0
  • Comments Comments (
    0
    ) |



Results & Comparisons


Results Data
Outcome: Mortality - All-cause (non-AE)      Population: All Participants
Time Point Measure Placebo Elective surgery


3 years

N Analyzed 81 26
Counts 0 0
P-Value Adjusted For:
Outcome: Recurrence of diverticulitis      Population: All Participants Between-Arm Comparisons
Time Point Measure Placebo Elective surgery Comparison Measure Placebo vs. Elective surgery


3 years

N Analyzed 81 26 0.009
Counts 26 2 Bonferroni adjustment
Percentage 32 8
Outcome: AE - Return to OR or unplanned procedure (CD III)      Population: All Participants
Time Point Measure Placebo Elective surgery


3 years

N Analyzed 81 26
Counts 0 1
Outcome: AE - Infection requiring Abx (CD II)      Population: All Participants
Time Point Measure Placebo Elective surgery


3 years

N Analyzed 81 26
Counts 0 1
Outcome: AE - Return to OR or unplanned procedure (CD III)      Population: All Participants
Time Point Measure Placebo Elective surgery


3 years

N Analyzed 81 26
Counts 0 0
Outcome: AE - Serious (SAE)      Population: All Participants
Time Point Measure Placebo Elective surgery


3 years

N Analyzed 81 26
Counts 0 1
Percentage
Outcome: AE - Ileus      Population: All Participants
Time Point Measure Placebo Elective surgery


3 years

N Analyzed 26
Counts 1
Percentage
P-Value
Outcome: Length of hospital (or intensive care unit) stay      Population: All Participants Between-Arm Comparisons
Time Point Measure Placebo Elective surgery Comparison Measure Elective surgery vs. Placebo


30 days

N Analyzed 81 26 0.903
Median 5 5.5
25th Percentile 4 4
75th Percentile 8 8.5
Median
25th Percentile
75th Percentile
Outcome: Recurrence of diverticulitis      Population: All Participants
Time Point Measure Placebo Elective surgery


3 years

N Analyzed 81 26
Median 7 11
25th Percentile 3.25 8
75th Percentile 15 14
Median
25th Percentile
75th Percentile


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 Low
  • Comments Comments (
    0
    ) |
Q15: Cochrane - Allocation concealment (selection bias): Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment Low
  • 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 open study
  • 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 open study
  • 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. High open study
  • Comments Comments (
    0
    ) |
Q20: Cochrane - Incomplete outcome data (attrition bias): Attrition bias due to amount, nature or handling of incomplete outcome data Low
  • Comments Comments (
    0
    ) |
Q21: Cochrane - Selective Reporting (reporting bias): Reporting bias due to selective outcome reporting Low
  • 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?
  • Comments Comments (
    0
    ) |
Q3: ROBINS-I 1.4. Did the authors use an appropriate analysis method that controlled for all the important confounding domains?
  • 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?
  • 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?
  • Comments Comments (
    0
    ) |
Q6: ROBINS-I - Risk of bias judgement for BIAS DUE TO CONFOUNDING
  • 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?
  • 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?
  • 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?
  • Comments Comments (
    0
    ) |
Q10: ROBINS-I 2.4. Do start of follow-up and start of intervention coincide for most participants?
  • 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?
  • Comments Comments (
    0
    ) |
Q13: ROBINS-I - Risk of bias judgement for BIAS IN SELECTION OF PARTICIPANTS INTO THE STUDY
  • Comments Comments (
    0
    ) |
Q2: Did the study divide the follow up time of each individual participant into the different interventions?
  • Comments Comments (
    0
    ) |
Q11: Did the start and follow up calendar years coincide for most participants in the study?
  • 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. High open study
  • 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
No quality rating data was found.