CI: Initiation of Enteral Nutrition (2012)

Study Design:
- Click here for explanation of classification scheme.
Quality Rating:
Research Purpose:
To determine whether a period of starvation after gastrointestinal surgery is provides any benefit. 
Inclusion Criteria:
  1. Randomized Clinical Control Trials (RCT) comparing any type of enteral feeding started within 24 hours after surgery to “nil by mouth” management.
  2. Patients had undergone elective gastrointestinal surgery.
  3. Patients were randomly allocated to receive either enteral feeding within 24 hours or nil by mouth treatment with the introduction of fluids and diet as tolerated.
Exclusion Criteria:
  1. Trials other than RCT.
  2. Trials including patients who had undergone surgeries other than elective gastrointestinal surgery.
  3. Patients were not randomly selected to receive enteral feeding within 24 hours or nil by mouth treatment with the introduction of fluids and diet as tolerated.
Description of Study Protocol:
Trials for this review were identified through computerized searches using Pub Med, Embase, and the Cochrane controlled trials register.
Each study was examined and researchers recorded data regarding the site of surgery, whether an intestinal anastomosis was formed, whether the pathology was benign or malignant, the type of feed used, and the method of administration of the feed. 
Outcomes related to the method of feed were also recorded.  These included infection of any type, anastomotic dehiscence, vomiting, mortality, and length of stay. 
Data Collection Summary:
  1. Anastomotic dehiscence
  2. Infection of any type
  3. Pneumonia
  4. Intra-abdominal abscess
  5. Vomiting
  6. Mortality
  7. Length of hospital stay
Description of Actual Data Sample:

13 randomized control trials were included. 

Two were excluded because information on pertinent outcomes was not reported. 

929 total patients included.

Summary of Results:
Methodological Quality
Overall concealment of allocation of treatment was poor. 
Anastomotic Dehiscence
 7 trials showed that early feeding led to a reduction in risk. 
  • Sager et al, (0.33)
  • Reissman et al (0.34)
  • Beier-Holgersen et al (0.50)
  • Ortiz et al (0.50)
  • Heslin et al (0.76)
  •  Hartsell et al (0.33)
  •  Watters et al 0.27)
Risk of Infection
The risk for infection was obtained from all but two trials.  The combine relative risk for the remaining 9 trials was 0.72 which is a significant reduction in the risk of infection. 
Similar reductions were found for wound infection and pneumonia.
  An increase in the risk of vomiting was noted in the early enteral feeding group.  (1.27, 1.01 to 1.61, P=0.045)
Mortality was reported in 9 of the 11 studies.  10 deaths occurred in the control group and 4 deaths in the early enteral feeding groups. 
(RR 0.48, 0.18 to 1.29 P=0.15)
Length of Hospital Stay
Early enteral feeding group mean length of stay was 6.2 to 14.0 days compared to the control group’s 6.8 to 19.0 days.  There was a significant reduction of 0.84 day (0.36 to 1.33 days, P = 0.001).
Author Conclusion:
There does not appear to be evidence suggesting any benefits of the “nil by mouth” belief. 
Enteral feeding may be beneficial for these patients.
Data is insufficient to come to a definite conclusion; there is a good case for a sufficiently powered and performed clinical trial to assess the use of early enteral feedings in this type of patient. 
This is an area where evidence is lacking; more research in this area is needed to make an evidence-based decision.
Funding Source:
Reviewer Comments:
The majority of the articles reviewed were limited, and had inadequate or unclear allocation concealment.  Intention to treat was lacking in most trials.
Additional unpublished data was obtained for six of the trials; Researchers did not indicate whether all needed data was obtained for all of the trials. 
Data regarding infection and mortality was missing from two of the studied trials. 
Researchers did not describe whether the review was adequately performed with two independent reviewers analyzing material.
Quality Criteria Checklist: Review Articles
Relevance Questions
  1. Will the answer if true, have a direct bearing on the health of patients? Yes
  2. Is the outcome or topic something that patients/clients/population groups would care about? Yes
  3. Is the problem addressed in the review one that is relevant to dietetics practice? Yes
  4. Will the information, if true, require a change in practice? Yes
Validity Questions
  1. Was the question for the review clearly focused and appropriate? Yes
  2. Was the search strategy used to locate relevant studies comprehensive? Were the databases searched and the search termsused described? Yes
  3. Were explicit methods used to select studies to include in the review? Were inclusion/exclusion criteria specified andappropriate? Wereselectionmethods unbiased? Yes
  4. Was there an appraisal of the quality and validity of studies included in the review? Were appraisal methodsspecified,appropriate, andreproducible? Yes
  5. Were specific treatments/interventions/exposures described? Were treatments similar enough to be combined? Yes
  6. Was the outcome of interest clearly indicated? Were other potential harms and benefits considered? Yes
  7. Were processes for data abstraction, synthesis, and analysis described? Were they applied consistently acrossstudies and groups? Was thereappropriate use of qualitative and/or quantitative synthesis? Was variation in findings among studies analyzed? Were heterogeneity issued considered? If data from studies were aggregated for meta-analysis, was the procedure described? No
  8. Are the results clearly presented in narrative and/or quantitative terms? If summary statistics are used, are levels ofsignificance and/or confidence intervals included? Yes
  9. Are conclusions supported by results with biases and limitations taken into consideration? Are limitations ofthe review identified anddiscussed? Yes
  10. Was bias due to the review's funding or sponsorship unlikely? Yes