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Inclusion and exclusion criteria:
Consecutive patients undergoing open elective colonic surgery at Manukau Surgical Centre were invited to participate in this study. These patients were managed within an Enhanced Recovery After Surgery (ERAS) program, where other factors which may influence POF are controlled.(285-287) Discharge criteria were the ability to pass flatus, eat and drink without discomfort and maintain adequate analgesia with oral medications alone. Previously established exclusion criteria for our ERAS program included American Society of Anaesthesiologists score (ASA) greater than or equal to IV, a requirement for a stoma, inability to speak English and cognitive impairment.(285-287) For this study in particular, patients receiving steroids or other immunosuppressant medications were also excluded. Ethical approval from regional and local ethics committees was obtained.
Outcome measures
Fatigue was measured preoperatively, and at days 3, 7, 30 and 60 using the IdentityConsequence Fatigue Scale (ICFS). The ICFS is a validated, multi-dimensional measure which has been specifically designed to measure fatigue and return to normal activity in surgical patients.(24, 281, 288) A surgical drain (15 F Blake drain, Johnson & Johnson, Somerville, NJ) was left in the peritoneal cavity at the conclusion of the operation. Plasma samples were taken preoperatively and on the morning of day 1 simultaneously with a sample of drain fluid. This time was chosen, because peritoneal IL-6 levels peak at this time.(87) The samples were collected in buffered Sodium Citrate tubes.
Power calculation and statistical analysis
Based on previous data,(24, 281, 288) we calculated that in order to reduce day 30 ICFS scores by 50% with a type I error of 0.05 and a type II error of 0.2, 30 patients would be required in each arm of the study. We aimed to include 70 to allow for possible drop outs. Results were analysed using SPSS® for Windows® version 14.0 (SPSS, Chicago, Illinois, USA). Relationships between groups were assessed using the χ2 test for binary outcomes and continuous variables were compared using the Mann–Whitney U test. Correlations were expressed using Spearman’s rho (correlation coefficient). Statistical significance was accepted at the 0.05 level.
Post-Operative Fatigue
Figure 5 and Figure 6 show that there were no differences in the baseline scores for Post Operative Fatigue (POF) or Fatigue Consequence (FC) as measured by ICFS. POF increased in both groups reaching a maximum at day 3 and declined gradually thereafter. POF and FC were significantly less for the Dexamethasone group on days 3 and 7. These differences were not maintained at days 30 or 60. Total fatigue Score and Total fatigue Consequence as measured by Area Under The Curve were significantly smaller for the Dex group.
Cytokine levels
At the time of sample collection on the morning of day 1, there was no difference in the volume of drain fluid between the Dexamethasone (160 mls, 40-450) and the Placebo (150 mls, 20-400) groups (P=0.455). Table 28 shows that there was a strong trend towards reduced concentration of plasma and peritoneal cytokines in the Dexamethasone group. The data were not normally distributed and non-parametric statistics were used. The difference between the groups reached statistical significance for peritoneal IL-6 and IL-13 and plasma levels of IL-6 and IL-8. There were significant correlations between plasma IL-6 concentrations and POF and FC from day 3 to day 60 in both placebo and Dexamethasone groups (Table 29).
Other clinical outcomes:
Patients in the Dexamethasone group had significantly lower VAS nausea scores at days 1, 2 and 3 (Table 31). Subjective VAS vomiting scores and the number of daily vomiting episodes were significantly lower for the Dexamethasone group on day 1. There was no difference in antiemetic use between the two groups (Table 30), but patients in the Dexamethasone group passed flatus 1 day earlier (2 vs. 3 days, P=0.013). Median pain scores at rest and while coughing were significantly lower for the Dexamethasone group at day 3 only (Table 32). There were no differences the use of epidurals or oral analgesia use between the two groups at any time point (Table 30). At days 1 and 2 there was a small but statistically significant difference in the subjective VAS sleep scores between the 2 groups, favouring the Dexamethasone group (Table 32).
Table of Contents :
- Abstract
- Dedications
- Acknowledgements
- Acknowledgements
- Table of Contents
- Table of Figures
- List of Tables
- Glossary
- Chapter 1 : Overview of Post Operative Fatigue
- Introduction
- Why is POF important?
- Assessment of Fatigue
- OBJECTIVE CORRELATES WITH POF
- Cardiovascular fitness
- Fatigue and nutrition
- Fatigue and Musculoskeletal changes
- Fatigue and biochemical markers
- Fatigue and type of operation
- Fatigue and Psychological factors
- Aetiology of POF
- Fatigue and nutrition
- Fatigue and Physical Fitness
- Fatigue and Psychological Theory
- Fatigue and Inflammatorily Cytokines: A Hypothesis
- Prevention and Treatment of POF
- Summary
- Chapter 2 : Overview of Enhanced Recovery After Surgery Pathways
- Introduction
- Pre-Operative Care
- Information
- Pre-habilitation
- Alcohol, Smoking and Surgery
- Nutritional Support
- Pre-Operative Fasting
- Mechanical bowel preparation
- Environmental factors
- Nursing Care
- Intra-Operative
- Prophylactic Antibiotics
- Perioperative Oxygen Therapy
- Epidural anaesthesia
- The Choice of Incision
- Laparoscopic Surgery
- Prophylactic Use of Drains
- Prophylactic Use of Nasogastric Tubes
- Intra-Operative Fluid therapy
- Post-Operative
- Post Operative Nausea and Vomiting
- Early Oral Feeding and post-operative dietary supplementation
- Balanced analgesia
- Postoperative Urinary Drainage
- Conclusion
- Chapter 3 : Materials and Methods
- Chapter 4 : A Prospective Study on Clinical Benefits of ERAS
- Chapter 5 : Can ERAS Influence Post Operative Fatigue? – A prospective Study
- Chapter 6 : Double Blinded Randomised Trial on the Influence of Dexamethasone on Post Operative Fatigue
- Chapter 7 : Conclusion
- Chapter 8 : Appendix
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Multimodal Interventions for Improving Convalescence Following Major Colonic Surgery