Advanced Search

Study Preview



Study Title and Description

Randomized, prospective comparison of cefoxitin and gentamicin-clindamycin in the treatment of acute colonic 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?
  • Comments Comments (
    0
    ) |

Primary Publication Information
  • Comments Comments (
    0
    ) |
TitleData
Title Randomized, prospective comparison of cefoxitin and gentamicin-clindamycin in the treatment of acute colonic diverticulitis.
Author Kellum JM., Sugerman HJ., Coppa GF., Way LR., Fine R., Herz B., Speck EL., Jackson D., Duma RJ.
Country Department of Surgery, Medical College of Virginia, Virginia Commonwealth University, Richmond.
Year -- Not Found --
Numbers Pubmed ID: 1638578

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 Antibiotics: Gentamicin-Clindamycin
  • Comments Comments (
    0
    ) |
2 Antibiotics: Cefoxitin
  • Comments Comments (
    0
    ) |

Design Details
Question... Follow Up Answer Follow-up Answer
Specific KQ KQ 2b: Antibiotics (acute)
  • Comments Comments (
    0
    ) |
Study Design RCT
  • Comments Comments (
    0
    ) |
Country USA
  • Comments Comments (
    0
    ) |
Study name
  • Comments Comments (
    0
    ) |
Associated articles
  • Comments Comments (
    0
    ) |
ClinicalTrials.gov identifier
  • Comments Comments (
    0
    ) |
Start and end years of the Study NR
  • Comments Comments (
    0
    ) |
NR
  • Comments Comments (
    0
    ) |
Inclusion criteria Acute diverticulitis considered present if there was abdominal tenderness, signs of infection (fever or leukocytosis), radiological, surgical or pathological evidence.
  • Comments Comments (
    0
    ) |
Exclusion criteria creatinine >/= 3mg/dl
  • Comments Comments (
    0
    ) |
Specific population? No (all comers)
  • Comments Comments (
    0
    ) |
Was diverticulitis diagnosed with CT? ... Unclear/Multiple methods (explain) ... Multiple: CT or water/barium enema
  • Comments Comments (
    0
    ) |
If NRCS, what analytic method was used to account for differences between study arms?
  • Comments Comments (
    0
    ) |
How was diverticulitis diagnosed Acute diverticulitis considered present if there was abdominal tenderness, signs of infection (fever or leukocytosis), radiological, surgical or pathological evidence.
  • Comments Comments (
    0
    ) |
Note/Comment about Design (or overall study)
  • Comments Comments (
    0
    ) |


Baseline Characteristics
Question Antibiotics: Gentamicin-Clindamycin Antibiotics: Cefoxitin Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant race/ethnicity characteristics Not reported Not reported Not reported
  • Comments Comments (
    0
    ) |
Participant Age - Continuous data (in years) Mean 60.8 Mean 64.5
  • Comments Comments (
    0
    ) |
SE 3 SE 2
  • Comments Comments (
    0
    ) |
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 Not reported Not reported
  • Comments Comments (
    0
    ) |
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: Elective surgical treatment      Population: All Participants
Time Point Measure Antibiotics: Gentamicin-Clindamycin Antibiotics: Cefoxitin


Enter a numeric value or title (required) years

N Analyzed 21 30
Counts 0 6
Percentage 0 20
Outcome: Urgent or emergency surgery      Population: All Participants
Time Point Measure Antibiotics: Gentamicin-Clindamycin Antibiotics: Cefoxitin


Enter a numeric value or title (required) years

N Analyzed 21 30
Counts 2 2
Percentage 9.5 6.67


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 label
  • 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 label
  • 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
  • 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
  • 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.