Study Preview
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? |
Primary Publication Information
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 | |
2 | Antibiotic: Ertapenem | 7 days |
Question... Follow Up | Answer | Follow-up Answer | |
---|---|---|---|
Specific KQ | KQ 2b: Antibiotics (acute) | ||
KQ 2b: Antibiotics (acute) | |||
Study Design | RCT | ||
RCT | |||
Country | Germany | ||
Germany | |||
Funder | Industry (fully or in part) | ||
Study name | |||
Associated articles | |||
ClinicalTrials.gov identifier | NCT00097734 | ||
Start and end years of the Study | 2004 | ||
2008 | |||
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. | ||
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. | ||
if not an RCT, what was the directionality? | Prospective | ||
Specific population? | No (all comers) | ||
Was diverticulitis diagnosed with CT? | CT | ||
If NRCS, what analytic method was used to account for differences between study arms? |
Baseline Characteristics
Question | Antibiotic: Ertapenem | Antibiotic: Ertapenem | Total | Comments | |||
---|---|---|---|---|---|---|---|
Answer | Follow-up | Answer | Follow-up | Answer | Follow-up | ||
Participant race/ethnicity characteristics | Male | 54 | Male | 55.4 | Male | 54.7 | |
Participant Age - Continuous data (in years) | Mean | 60.6 | Mean | 58.5 | Mean | 59.4 | |
SD | 12.2 | SD | 11.9 | SD | 12.1 | ||
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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. | |
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. | |
Q16: Cochrane - Blinding of participants (performance bias): Performance bias due to knowledge of the allocated interventions by participants during the study | High | Open-label | |
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 | |
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 | |
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%. | |
Q21: Cochrane - Selective Reporting (reporting bias): Reporting bias due to selective outcome reporting | Unclear | Study protocol is unavailable, but expected outcomes were reported. | |
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. | |
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. | No | Open-label | |
Q23: NHLBI - Were eligibility/selection criteria for the study population prespecified and clearly described? | |||
Q24: NHLBI - Was the test/service/intervention clearly described and delivered consistently across the study population? | |||
Q25: NHLBI - Were the outcome measures prespecified, clearly defined, valid, reliable, and assessed consistently across all study participants? |
Quality Rating
No quality rating data was found.