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ONC: Nutrition Status and Outcomes in Adult Oncology Patients (2013)

Citation:

Ionescu D, Iancu C, Ion D, Al-Hajjar N, Margarit S, Mocan L, Mocan T, Deac D, Bodea R, Vasian H. Implementing fast-track protocol for colorectal surgery: A prospective randomized clinical trial. World J Surg. 2009 Nov; 33(11): 2,433-2,438.

PubMed ID: 19707815
 
Study Design:
Randomized Controlled Trial
Class:
A - Click here for explanation of classification scheme.
Quality Rating:
Positive POSITIVE: See Quality Criteria Checklist below.
Research Purpose:

To compare a fast-track protocol in colorectal surgery with conventional care in our university hospital with the goal of implementing such a protocol in our daily practice.

Inclusion Criteria:
  • Complete self-ambulation
  • Good tolerance to normal feeding
  • Minor pain controlled with paracetamol and NSAID
  • No surgical complication at the time of discharge.
Exclusion Criteria:
  • Previous abdominal surgery
  • Extensive neoplasm
  • Severe malnutrition
  • Surgery for complications (bowel obstruction)
  • Palliative surgical procedures.
Description of Study Protocol:

Recruitment

Patients who were admitted to hospital between October 2006 and May 2007 for elective open colorectal surgery for neoplasm.

Design

Prospective randomized study.

Blinding Used

Patients were randomly allocated by computer program in two groups:

  • Group One: Patients undergoing open colorectal surgery in a fast-track protocol (FT group)
  • Group Two: Patients undergoing open surgery with a conventional care program (C group).

Intervention

The intervention was the fast-track protocol post-op vs. conventional care post-op. 

  • Fast-track group (FT) included:
    • No bowel prep except fluids 18 hours prior to surgery
    • Mobilization in bed post-surgery
    • Discharge to high-dependency unit post-surgery
    • Fluids as tolerated post-surgery
    • Multi-modal analgesia
    • Prokinetics
    • Walking on day one post-surgery
    • Fluids and solid foods day one post-surgery (yogurt, cheese)
    • Bladder catheter removal day one post-surgery
    • Discharge to surgical floor if possible
    • Normal feeding on day two post-surgery
    • Epidural catheter removed on day two post-surgery (if present)
  • Conventional care (C group) included:
    • Mechanical bowel prep
    • No fluids day of surgery
    • Discharge to high-dependency unit post-surgery
    • Mobilization in bed post-surgery
    • NG tube, no fluids by mouth post-surgery
    • Multi-modal analgesia
    • Walking on day one post-surgery
    • NG tube, no fluids or foods by mouth post-surgery day one
    • Bladder catheter in place
    • Discharge to surgical floor if possible
    • Fluids by mouth if tolerated on day two post-surgery
    • If no bowel passage or fluids not tolerated, NG tube remains in place
    • Remove bladder catheter day two post-surgery
    • Epidural catheter removed on day two post-surgery (if present)
  • Note: 22 FT patients had thoracic epidural catheters placed for analgesia; 23 conventional group patients had thoracic epidural catheters for the same purpose.

Statistical Analysis

  • Statistical analysis performed using SPSS for Windows
  • Sample size calculations were based on a pilot study on 20 patients, considering type one and type two errors
  • Chi-square or Fisher's exact test were used
  • Normality of numerical data was assessed by means of Shapiro-Wilk test results
  • Numerical data were analyzed using Mann-Whitney U test or Student's T-test for independent samples
  • P<0.05 
Data Collection Summary:

Timing of Measurements

 Several variables were measured throughout the post-operative course.

Dependent Variables

  • Intensity of post-operative pain on VAS: Measured every six hours (zero, no pain; five, the worst pain possible)
  • Independent ambulation: Time to complete mobilization out of bed
  • Time to first restoration of bowel function
  • Time to oral intake of both fluids and solid food
  • The incidence of side effects:
    • PONV
    • Shivering
    • Dizziness
    • Fatigue
  • Incidence of post-operative complications:
    • Fistulas
    • Wound infections
    • Cardiorespiratory complications
    • Other complications
  • Length of stay in high-dependency unit (HDU)
  • Hospitalization time.

Independent Variables

Patient admitted for elective open colorectal surgery for neoplasm. 

Description of Actual Data Sample:
  • Initial N: 96 patients (61 males; 35 females)
  • Attrition (final N): 96 patients (61 males; 35 females)
  • Age: Average age for:
    • Group one: 60.94±9.9
    • Group two: 63.1±12.19
  • Anthropometrics: 
    • Patient demographics were similar in the two groups according to age, sex, anesthetic risk, duration of surgery, surgical procedure, and the incidence of coexisting diseases
    • Study groups were similar for the type of surgery; rectosigmoidian resection was the most frequent operation that was performed in study groups
  • Location: Hospital in Romania.
Summary of Results:

Key Findings

  • Patients included in fast-track group have had a significantly shorter time to complete mobilization (P<0.05) and to tolerate earlier feeding (fluid and solid food intake; P<0.05)
  • The length of high dependency unit (HDU) and hospital stay was significantly shorter in fast-track group (HDU stay 0.92±1.11 days vs. 1.77±1.46 days; hospital stay 6.43±3.41 days vs. 9.16±2.67 days; P=0.001 for both)
  • No statistical differences between the incidences of complications in study groups
  • No statistical differences in the incidence of post-operative nausea and vomiting in study groups, although post-operative nausea and vomiting had a smaller incidence in the fast-track group
  • Morphine requirements were significantly higher in the conventional care group (P=0.007)
  • Time to bowel function restoration was significantly shorter in the FT group (P=0.042)
  • Time to bowel function restoration was shorter in the epidural group for both study groups (35 vs. 43 hours in FT; 42 vs. 52 hours in C).
Author Conclusion:

Our fast-track protocol was followed by a significantly reduced hospital stay and better outcome for patients from the point of view of early re-feeding and mobilization. Fast-track protocol did not increase the incidence of complications.

Funding Source:
University/Hospital: A hospital in Romania
Reviewer Comments:
  • Never stated funding sources; it is assumed funding came from the hospital
  • Analysis of data regarding epidural vs. non-epidural patients was post-hoc
  • All FT patients received surgery from the same senior surgeon; all C patients received surgery from another senior surgeon. Although the authors state that both surgeons were similar in experience and results, it is possible that study results were affected by assignment of surgeon.
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? ???
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? 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? 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? Yes
  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? Yes
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? ???
10. Is bias due to study's funding or sponsorship unlikely? No
  10.1. Were sources of funding and investigators' affiliations described? No
  10.2. Was the study free from apparent conflict of interest? ???