EAL

CI: Initiation of Enteral Nutrition (2012)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To investigate the feasibility and efficacy of immediate post-operative enteral feeding (TEN) in patients with non-traumatic intestinal perforation and peritonitis.

Inclusion Criteria:

All patients with non-traumatic intestinal perforation and peritonitis treated in the surgical unit during the year-long study.

Exclusion Criteria:

Cardiac, renal or hepatic failure at time of admission
Operated on somewhere other than study’s hospital.

Description of Study Protocol:

All patients underwent laparotomy for peritonitis and were then randomly assigned to the study or control group. A jejunostomy feeding tube was placed in those assigned to the study group. All were evaluated with hematologic, biochemical and radiologic tests and assigned a sepsis severity score based on Elebute and Stoner.
Post-operative control patients received intravenous fluids and electrolyte supplements as needed
The study group received EN post-op as follows:
- 12 to 24 hours at 1:3 ratio of saline and 5% dextrose at 100ml per hour
- 24 to 48 hours 1.0L of half-strength formula at 50ml per hours
- 48 to 72 hours 2L full-strength per 24 hours
Feeding was decreased or stopped if patient experienced abdominal pain or distention and restarted after 12 hours. EN formula was milk-based and produced by hospital staff. Once bowel activity returned, oral feeding resumed. Tube feeding was stopped when oral intake was sufficient.
Nutritional status was evaluated at admission, day four and day 7
Nutritional needs were estimated using the Harris-Benedict equation
Nitrogen output was measured by estimating 24-hour urinary urea. Input was calculated from diet consumed, plasma and albumin supplements.

Data Collection Summary:

Anthropometric indices (weight, triceps skin fold, mid-arm circumference), weight loss and serum albumin levels were measured. Cause of death and length of hospital (LOS) were also examined.

Description of Actual Data Sample:

43 patients met entry criteria and were included in the study (21 patients in study group and 22 in control group).

Summary of Results:

Study group had higher sepsis scores than the control group (P<0.05)
Anthropometric and serum albumin levels did not reveal any changes during study
13 patients in the control group developed complications vs. 11 in the study group
22 septic complications in control vs. eight in study group (P<0.05)
Eight patients died during the study
- Four patients from control group (ulcer and ileal perforations)
- Four patients from study group (gastric, jejunal and ileal perforations)
All but one patient reached caloric requirement by day four post-op
Study group achieved positive nitrogen balance by day three post-op and the control group remained in negative nitrogen balance through out study
No significant difference in LOS.

Author Conclusion:

TEN patients had a significantly higher sepsis scores leading to an initial disadvantage, but better outcomes were observed in these patients than in the control patients. This study shows that TEN is feasible and beneficial to patients with peritonitis.

Funding Source:

University/Hospital:

PGIMER-Postgraduate Institute of Medical Education and Research (India)

Reviewer Comments:

Randomization not well defined.
Not blinded.

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")?	N/A
4.	Was method of handling withdrawals described?		Yes
	4.1.	Were follow-up methods described and the same for all groups?	N/A
	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?	N/A
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?	Yes
	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)?	Yes
	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?	???
	10.2.	Was the study free from apparent conflict of interest?	Yes