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Study Title and Description

Prospective randomized trial comparing short-term antibiotic therapy versus standard therapy for acute uncomplicated sigmoid diverticulitis.



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?
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Primary Publication Information
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TitleData
Title Prospective randomized trial comparing short-term antibiotic therapy versus standard therapy for acute uncomplicated sigmoid diverticulitis.
Author Schug-Pass C., Geers P., Hügel O., Lippert H., Köckerling F.
Country Department of Surgery, Center for Minimally Invasive Surgery, Vivantes Hospital Spandau, Neue Bergstrasse 6, 13585 Berlin, Germany. christine.schug-pass@vivantes.de
Year 2010
Numbers Pubmed ID: 20140619

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 Antibiotic: Ertapenem 4 days
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2 Antibiotic: Ertapenem 7 days
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Design Details
Question... Follow Up Answer Follow-up Answer
Specific KQ KQ 2b: Antibiotics (acute)
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KQ 2b: Antibiotics (acute)
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Study Design RCT
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RCT
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Country Germany
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Germany
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Funder Industry (fully or in part)
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Study name
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Associated articles
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ClinicalTrials.gov identifier NCT00097734
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Start and end years of the Study 2004
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2008
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Inclusion criteria Age 18-75 yo. Has at least 2 of following symptoms: fever, abdominal resistance, leukocyte >10,000/μl, CRP (≥20 and ≥ 2 mg/dl), detection of sigmoid diverticulitis using contrast medium. CT evidence. Conservative Tx possible.
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Exclusion criteria Study Tx or other betalactam. Hypersensitivity to betalactam. Immunosuppressant use. Antibiotic Tx within 2 weeks before enrollment. Incurable hematological/oncological diseases. Pregnancy. Existing sigmoid diverticulitis requiring surgery.
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if not an RCT, what was the directionality? Prospective
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Specific population? No (all comers)
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Was diverticulitis diagnosed with CT? CT
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If NRCS, what analytic method was used to account for differences between study arms?
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Baseline Characteristics
Question Antibiotic: Ertapenem Antibiotic: Ertapenem Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant race/ethnicity characteristics Male 54 Male 55.4 Male 54.7
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Participant Age - Continuous data (in years) Mean 60.6 Mean 58.5 Mean 59.4
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SD 12.2 SD 11.9 SD 12.1
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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: Adverse event - any      Population: All Participants
Time Point Measure Antibiotic: Ertapenem Antibiotic: Ertapenem


Baseline N/A

N Analyzed 50 56
Counts 3 0
Percentage 5.1 0
Outcome: AE - Allergic reaction (major)      Population: All Participants
Time Point Measure Antibiotic: Ertapenem Antibiotic: Ertapenem


Baseline N/A

N Analyzed 50 56
Counts 1 0
Percentage 2 0
Outcome: Adverse event - headache      Population: All Participants
Time Point Measure Antibiotic: Ertapenem Antibiotic: Ertapenem


Baseline N/A

N Analyzed 50 56
Counts 2 0
Percentage 4 0
Outcome: AE - Serious (SAE)      Population: All Participants
Time Point Measure Antibiotic: Ertapenem Antibiotic: Ertapenem


Baseline N/A

N Analyzed 50 56
Counts 0 0
Percentage 0 0
P-Value
Outcome: Treatment success rate      Population: All Participants Between-Arm Comparisons
Time Point Measure Antibiotic: Ertapenem Antibiotic: Ertapenem Comparison Measure Antibiotic: Ertapenem vs. Antibiotic: Ertapenem


1 months

N Analyzed 50 56 N.S.
Counts 47 54
Percentage 94 96.4
P-Value
Outcome: Additional antibiotic therapy      Population: All Participants Between-Arm Comparisons
Time Point Measure Antibiotic: Ertapenem Antibiotic: Ertapenem Comparison Measure Antibiotic: Ertapenem vs. Antibiotic: Ertapenem


1 years

N Analyzed 39 49 N.S.
Counts 4 3
Percentage 10.3 6.1
P-Value
Outcome: Recurrence      Population: All Participants Between-Arm Comparisons
Time Point Measure Antibiotic: Ertapenem Antibiotic: Ertapenem Comparison Measure Antibiotic: Ertapenem vs. Antibiotic: Ertapenem


1 years

N Analyzed 40 48 N.S.
Counts 3 5
Percentage 7.5 10.4
P-Value
Outcome: Diverticulitis-related morbidities      Population: All Participants Between-Arm Comparisons
Time Point Measure Antibiotic: Ertapenem Antibiotic: Ertapenem Comparison Measure Antibiotic: Ertapenem vs. Antibiotic: Ertapenem


1 years

N Analyzed 40 48 N.S.
Counts 1 1
Percentage 2.5 2.1
P-Value
Outcome: Parenteral nutrition      Population: All Participants Between-Arm Comparisons
Time Point Measure Antibiotic: Ertapenem Antibiotic: Ertapenem Comparison Measure Antibiotic: Ertapenem vs. Antibiotic: Ertapenem


5 days

N Analyzed 50 56 <0.001
Counts 3 47
Percentage 6 83.9
P-Value
Outcome: Diverticulitis-related morbidities      Population: All Participants Between-Arm Comparisons
Time Point Measure Antibiotic: Ertapenem Antibiotic: Ertapenem Comparison Measure Antibiotic: Ertapenem vs. Antibiotic: Ertapenem


1 years

N Analyzed 43 48 N.S.
Counts 1 0
Percentage 2.3 0
P-Value
Outcome: Abscess      Population: All Participants Between-Arm Comparisons
Time Point Measure Antibiotic: Ertapenem Antibiotic: Ertapenem Comparison Measure Antibiotic: Ertapenem vs. Antibiotic: Ertapenem


1 years

N Analyzed 43 48 N.S.
Counts 1 0
Percentage 2.3 0
P-Value
Outcome: Surgery performed      Population: All Participants Between-Arm Comparisons
Time Point Measure Antibiotic: Ertapenem Antibiotic: Ertapenem Comparison Measure Antibiotic: Ertapenem vs. Antibiotic: Ertapenem


1 years

N Analyzed 43 48 N.S.
Counts 16 21
Percentage 37.2 42.9
P-Value
Outcome: Length of hospital (or intensive care unit) stay      Population: All Participants Between-Arm Comparisons
Time Point Measure Antibiotic: Ertapenem Antibiotic: Ertapenem Comparison Measure Antibiotic: Ertapenem vs. Antibiotic: Ertapenem


Baseline days

N Analyzed 50 56 0.002
Mean 7.8 9.7
SD 2.8 3.2
SE


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 Unclear Information regarding random sequence is not provided.
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Q15: Cochrane - Allocation concealment (selection bias): Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment Unclear Information regarding allocation concealment is not provided.
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Q16: Cochrane - Blinding of participants (performance bias): Performance bias due to knowledge of the allocated interventions by participants during the study High Open-label
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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-label
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Q18: Cochrane - FOR OBJECTIVE OUTCOMES - Blinding of outcome assessor (detection bias): Detection bias due to knowledge of the allocated interventions by outcome assessors. No Open-label
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Q20: Cochrane - Incomplete outcome data (attrition bias): Attrition bias due to amount, nature or handling of incomplete outcome data Low Reasons for missing outcome data was provided in Table 3. The percentage of drop-outs and withdrawals do not exceed 20%.
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Q21: Cochrane - Selective Reporting (reporting bias): Reporting bias due to selective outcome reporting Unclear Study protocol is unavailable, but expected outcomes were reported.
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Q22: Cochrane - Other Bias: Bias due to problems not covered elsewhere in the table. If yes, describe them in the Notes. Low Study appears to be free of other sources of bias.
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Q1: ROBINS-I 1.1 Is there potential for confounding of the effect of intervention in this study?
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Q3: ROBINS-I 1.4. Did the authors use an appropriate analysis method that controlled for all the important confounding domains?
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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?
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Q5: ROBINS-I 1.6. Did the authors control for any post-intervention variables that could have been affected by the intervention?
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Q6: ROBINS-I - Risk of bias judgement for BIAS DUE TO CONFOUNDING
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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?
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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?
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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?
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Q10: ROBINS-I 2.4. Do start of follow-up and start of intervention coincide for most participants?
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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?
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Q13: ROBINS-I - Risk of bias judgement for BIAS IN SELECTION OF PARTICIPANTS INTO THE STUDY
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Q2: Did the study divide the follow up time of each individual participant into the different interventions?
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Q11: Did the start and follow up calendar years coincide for most participants in the study?
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Q19: Cochrane - FOR SUBJECTIVE OUTCOMES - Blinding of outcome assessor (detection bias): Detection bias due to knowledge of the allocated interventions by outcome assessors. No Open-label
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Q23: NHLBI - Were eligibility/selection criteria for the study population prespecified and clearly described?
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Q24: NHLBI - Was the test/service/intervention clearly described and delivered consistently across the study population?
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Q25: NHLBI - Were the outcome measures prespecified, clearly defined, valid, reliable, and assessed consistently across all study participants?
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Quality Rating
No quality rating data was found.