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CI: Timing of Enteral Nutrition (2006)

Citation:

Moore, E, Jones, T. Benefits of immediate jejunostomy feeding after major abdominal trauma: A prospective, randomized study, The Journal of Trauma 26.19 (1986): 874-881.

PubMed ID: 3095557
 
Study Design:
Prospective, randomized study
Class:
A - Click here for explanation of classification scheme.
Quality Rating:
Positive POSITIVE: See Quality Criteria Checklist below.
Research Purpose:
To demonstrate differences in the occurrences of sepsis, complications, morbidity, length of stay and total cost between immediate enteral-fed patients post abdominal-injury vs. patients who only received D5W for five days post-operatively.
Inclusion Criteria:
  • Patients requiring emergent laprotomy 
  • Abdominal trauma index (ATI) greater than 15.
Exclusion Criteria:
  • Patients excluded had re-operation, death or transferred to another hospital
  • Ten of the original 75 were excluded from analysis, because of the prohibitive intolerance of jejunal feeding when ATI was greater than 40.
Description of Study Protocol:
  • Control patients were given D5W (100g per day) for five days post-operatively and then on high nitrogen TPN if not tolerating oral diet
  • The enteral group had a needle catheter jejunostomy placed and given elemental tube feeding Vivonex, begun 12 to 18 hours post-operatively. Rate increased at eight-hour intervals to full-strength at 125ml per hour, by a targeted goal of 72 hours.
Data Collection Summary:
  • Length of stay
  • Complications
  • Cost
  • Mortality.
Description of Actual Data Sample:
  • 53 of the original 75 were analyzed because they had ATI less than 40 and more than 15
    • 27 patients in the control group
    • 26 patients in the enteral-fed group
  • No significant differences in comparison to sex, age, injury mechanism, shock or weight.
Summary of Results:
  • 35% of the enteral-fed group analyzed had complications and one had post-operative sepsis. Of the 27 patients in the control group analyzed seven had sepsis and 11 (41%) had complications. 
  • The only significant changes occurred in nitrogen balance at day four (P<0.025) and seven (P<0.001) and TLC on day seven (P<0.05)
  • Septic morbidity was significant greater (P<0.025) in the control group
  • Average hospital length of stay for the control group was 28.6±6.1 days and 25.3±5.8 days for the enteral fed 
  • Hospital cost for the 31 control patients was $609,000 (mean $19,636±$3,396) compared to $505,000 (mean $16,280±$2,146) for the 32 enteral-fed patients.  
Author Conclusion:
  • In patients with heavily contaminated intraperitoneal wounds, enteral feeding significantly reduced the incidence of sepsis
  • Only one major infection occurred in patients with ATI 15 to 40 fed by needle catheter jejunostomy.
 
Funding Source:
University/Hospital: Denver General Hospital, The University of Colorado Health Sciences Center
Reviewer Comments:
  • Design was not blinded
  • Criteria definitions for outcome measures unclear
  • In this study, a clinical significance can be seen in complication occurrence, cost of hospitalization, septic morbidity and cost.
Quality Criteria Checklist: Primary Research
Relevance Questions
  1. Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies) Yes
  2. Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about? Yes
  3. Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice? Yes
  4. Is the intervention or procedure feasible? (NA for some epidemiological studies) Yes
 
Validity Questions
1. Was the research question clearly stated? Yes
  1.1. Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified? Yes
  1.2. Was (were) the outcome(s) [dependent variable(s)] clearly indicated? Yes
  1.3. Were the target population and setting specified? Yes
2. Was the selection of study subjects/patients free from bias? Yes
  2.1. Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study? Yes
  2.2. Were criteria applied equally to all study groups? Yes
  2.3. Were health, demographics, and other characteristics of subjects described? Yes
  2.4. Were the subjects/patients a representative sample of the relevant population? Yes
3. Were study groups comparable? Yes
  3.1. Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT) Yes
  3.2. Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline? Yes
  3.3. Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.) Yes
  3.4. If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis? N/A
  3.5. If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.) N/A
  3.6. If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")? Yes
4. Was method of handling withdrawals described? Yes
  4.1. Were follow-up methods described and the same for all groups? Yes
  4.2. Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.) Yes
  4.3. Were all enrolled subjects/patients (in the original sample) accounted for? Yes
  4.4. Were reasons for withdrawals similar across groups? Yes
  4.5. If diagnostic test, was decision to perform reference test not dependent on results of test under study? Yes
5. Was blinding used to prevent introduction of bias? No
  5.1. In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate? No
  5.2. Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.) No
  5.3. In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded? N/A
  5.4. In case control study, was case definition explicit and case ascertainment not influenced by exposure status? N/A
  5.5. In diagnostic study, were test results blinded to patient history and other test results? N/A
6. Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described? Yes
  6.1. In RCT or other intervention trial, were protocols described for all regimens studied? Yes
  6.2. In observational study, were interventions, study settings, and clinicians/provider described? N/A
  6.3. Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect? Yes
  6.4. Was the amount of exposure and, if relevant, subject/patient compliance measured? Yes
  6.5. Were co-interventions (e.g., ancillary treatments, other therapies) described? No
  6.6. Were extra or unplanned treatments described? No
  6.7. Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups? Yes
  6.8. In diagnostic study, were details of test administration and replication sufficient? N/A
7. Were outcomes clearly defined and the measurements valid and reliable? Yes
  7.1. Were primary and secondary endpoints described and relevant to the question? Yes
  7.2. Were nutrition measures appropriate to question and outcomes of concern? Yes
  7.3. Was the period of follow-up long enough for important outcome(s) to occur? Yes
  7.4. Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures? Yes
  7.5. Was the measurement of effect at an appropriate level of precision? Yes
  7.6. Were other factors accounted for (measured) that could affect outcomes? Yes
  7.7. Were the measurements conducted consistently across groups? Yes
8. Was the statistical analysis appropriate for the study design and type of outcome indicators? Yes
  8.1. Were statistical analyses adequately described and the results reported appropriately? Yes
  8.2. Were correct statistical tests used and assumptions of test not violated? Yes
  8.3. Were statistics reported with levels of significance and/or confidence intervals? Yes
  8.4. Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)? N/A
  8.5. Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)? Yes
  8.6. Was clinical significance as well as statistical significance reported? Yes
  8.7. If negative findings, was a power calculation reported to address type 2 error? N/A
9. Are conclusions supported by results with biases and limitations taken into consideration? Yes
  9.1. Is there a discussion of findings? Yes
  9.2. Are biases and study limitations identified and discussed? Yes
10. Is bias due to study's funding or sponsorship unlikely? Yes
  10.1. Were sources of funding and investigators' affiliations described? Yes
  10.2. Was the study free from apparent conflict of interest? Yes