Post operative nutritional supplementation and early feeding: an evidence based view of current treatment Steven Thomas University Hospitals Bristol

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1 Post operative nutritional supplementation and early feeding: an evidence based view of current treatment Steven Thomas University Hospitals Bristol Stephen Lewis Derriford Hospital Plymouth

2 Structure Early postoperative enteral nutrition Perioperative enteral supplements and ERAS Perioperative optimization gum and immunofeeding Post discharge feeding Future studies

3 Early post operative feeding after GI surgery BMJ 2001;323:

4 Early enteral nutrition within 24h of colorectal surgery versus later commencement of feeding for postoperative complications Henning Keinke Andersen1, Stephen J Lewis2, Steve Thomas3 1Building 11 B, Colorectal Cancer Group, Copenhagen, Denmark. 2Dept of Gastroenterology, Level 7, DerrifordHospital, Plymouth, UK. 3Department of Maxillofacial Surgery, Bristol Dental Hospital, Bristol, UK Contact address: Henning Keinke Andersen, Building 11 B, Colorectal Cancer Group, 23 Bispebjerg Bakke, Copenhagen, DK 2400 CPH NV, Denmark. HAND0010@bbh.regionh.dk. Editorial group: Cochrane Colorectal Cancer Group. Publication status and date: New search for studies and content updated (no change to conclusions), published in Issue 2, Review content assessed as up-to-date: 9 January 2011.

5 Wound infection Pneumonia Abdominal abscess

6 Anastomotic dehiscence Vomiting

7 Mortality

8 Length of stay

9 Patients treated according to the ERAS programme were eating 3 days earlier than the patients traditionally treated (p < 0.000). Two days after surgery 65% of the ERAS patients were eating normal food versus 7% of the pre-eras patients.

10 Structure Early postoperative enteral nutrition Perioperative enteral supplements and ERAS Perioperative optimization gum and immunofeeding Post discharge feeding Future studies

11 Preoperative carbohydrate treatment for enhancing recovery after elective surgery Mark D Smith 1,*, John McCall 2, Lindsay Plank 3, G Peter Herbison 4, Mattias Soop 5, Jonas Nygren 6 Editorial Group: Cochrane Anaesthesia Group Published Online: 15 JUN 2011

12 A randomised placebo controlled trial of preoperative carbohydrate drinks and early postoperative nutritional supplement drinks in colorectal surgery Lidder P, Thomas S, Fleming S, Hosie K, Shaw S, Lewis S Funded by a research award from Numico Research Wageningen, Netherlands

13 Insulin resistance as a determinant of post operative outcome Surgery induces a catabolic response with release of stress hormones and inflammatory mediators Results in cellular dysfunction and a loss of insulin sensitivity Insulin resistance has been related to post-operative complications and length of hospital stay IR measured by hyperinsulinaemic-euglycaemic clamp or HOMA-IR. Due to the differences in estimates made by these two instruments the data from each will be analaysed separately in meta-analysis.

14 Interventions and primary outcome Homeostatic model assessment (HOMA). HOMA has been widely employed in clinical research to assess insulin sensitivity. IR was assessed using HOMA as the product of fasting insulin (microu/l) and fasting plasma glucose (mmol/l) levels divided by 22.5 Insulin tolerance test (ITT). ITT measures the decline in serum glucose after an IV bolus of insulin (0.1U/kg) is administered. Insulin and glucose levels are sampled each 90s over the following 15 minutes. The faster the decline in glucose concentration, the more insulin sensitive the subject is. The short ITT yielded a good correlation with the euglycemic clamp. Some of the drawbacks of this method include the supraphysiologic insulin dose used and also the fact that the test does not differentiate peripheral versus hepatic insulin resistance.

15 Interventions and primary outcome Hyperinsulinemic Euglycemic Clamp It is regarded as being the gold standard to quantify insulin sensitivity in vivo. It measures the steady- state amount of glucose metabolized per unit of body weight during a whole-body exposure to a predetermined amount of insulin, while maintaining the plasma glucose within the euglycemic range, the variables of interest, glucose and insulin are clamped and therefore can be manipulated independently. This technique involves a primed continuous infusion of insulin while maintaining euglycemia (e.g., around 90 mg/dl) by infusing a variable amount of glucose. The more glucose infused per unit of time, the more sensitive the individual is to insulin. The hyperinsulinemic euglycemic clamp assumes that, as a result of insulin and glucose infusion, endogenous hepatic glucose production (HGP) is completely inhibited.

16 The hyperinsulinemic-euglycemic clamp technique is the most scientifically sound technique for measuring insulin sensitivity, and it's against this standard that all other tests are usually compared. Because this and similar "clamp" techniques are expensive, time consuming, and labor intensive, they are not very practical Hyperinsulinemic-euglycemic clamp. The gold standard for evaluating insulin sensitivity, this "clamp" technique requires a steady IV infusion of insulin to be administered in one arm. The serum glucose level is "clamped" at a normal fasting concentration by administering a variable IV glucose infusion in the other arm. Numerous blood samplings are then taken to monitor serum glucose so that a steady "fasting" level can be maintained. (In theory, the IV insulin infusion should completely suppress hepatic glucose production and not interfere with the test's ability to determine how sensitive target tissues are to the hormone.) The degree of insulin resistance should be inversely proportional to the glucose uptake by target tissues during the procedure. In other words, the less glucose that's taken up by tissues during the procedure, the more insulin resistant a patient is.

17 Interventions Preoperative participants received 400mls of supplement or placebo 2 hours before surgery Preoperative supplement Nutritcia PreOp (Numico CHO 50kcal per 100ml, 290 mosm/kg, ph 5 Pre-operative placebo (Identically packaged) Acesulfame-K, 0.64g per 100ml citrate, 0 kcal 290 mosm/kg, ph 5 Postoperative participants received 600 mls per day of nutritional supplement or placebo from immediately after their operation until discharge. Postoperative supplement Fortifresh (Nutritcia CHO 150kcal per 100ml, 965 mosm/kg, ph 5 Postoperative placebo (Identically packaged) Acesulfame-K, 0.64g per 100ml citrate, 0 kcal 290 mosm/kg, ph 5

18 Baseline characteristics Group A n=30 Group B n=32 Group C n=31 Group D n=27 (Placebo+ Placebo) (Active+ Placebo) (Placebo +Active) (Active+Active) Age (Years) 73 (63.8, 81) 69.0 (64.0, 73.8) 69.0 (61.0, 77.0) 70.0 (65.0, 78.0) Sex (Male:Female) 15:15 14:16 15:16 17:10 Baseline BMI (KgM -2 ) 25.7 (22.9, 28.2) 25.4 (21.9, 29.0) 25.8 (23.4, 27.9) 25.9 (22.2, 27.4) Recent wt loss (>5%:0-5%:0%) 16:13:1 17:13:2 21:8:2 12:13:2 Energy requirements (Kcal) 1358 (1273, 1544) 1346 (1221, 1553) 1376 (1210, 1451) 1451 (1196, 1626) POSSUM Score 2.55 (1.32, 5.08) 2.52 (1.33, 3.48) 2.82 (1.8, 4.5) 3.17 (1.8, 5.28) Anaesthetic time (min) 175 (124, 216) 150 (130, 200) 160 (135, 225) 170 (150, 200) Surgical time (min) 150 (109, 192) 135 (112, 174) 128 (105, 180) 145 (130, 180) Colectomy: Ant:Left hemi:right hemi:sigmoid 21:0:9:0 17:0:13:2 21:2:7:1 16:3:7:1

19 Enrollment Assessed for eligibility (n= 293 ) Excluded (n=173 ) Not meeting inclusion criteria (n=27) Declined to participate (n=137) Other reasons (n= 9) Randomized (n=120) Allocation Allocated to intervention (n=30) group A Preop - Placebo Postop - Placebo Allocated to intervention (n=32) group B Preop - Active Postop - Placebo Allocated to intervention (n=31) group C Preop - Placebo Postop - Active Allocated to intervention (n=27) group D Preop - Active Postop - Active Follow-Up Lost to follow-up (n= 0) Lost to follow-up (n= 0) Lost to follow-up (n= 0) Lost to follow-up (n= 0) Analysis Analysed (n=30 ) Analysed (n=32) Analysed (n=31 ) Analysed (n=27)

20 Feed consumed in millilitres (median), and % of normal diet consumed Group A Group B Group C Group D (Placebo+Placebo) (Active+Placebo) (Placebo+Active) (Active+Active) Supplement consumed OD pre (ml) Supplement consumed OD post (ml) Supplement consumed POD1 (ml) Supplement consumed POD2 (ml) Supplement consumed POD3 (ml) Normal diet (%) OD post Normal diet (%) POD Normal diet (%) POD Normal diet (%) POD

21 Interventions and primary outcome A carbohydrate drink was only consumed by 50% of participants in the initial ERAS cohort and by 67% in the improved ERAS adherence cohort. Similarly only 12% of the initial ERAS cohort and 57% of the enhanced adherence cohort took first postoperative day supplements. (Gustafsson et al Arch Surg. 2011;146(5): ) Ersta Hospital in Stockholm, Sweden, is one of the original centers in the European ERAS Study Group. Key components in this protocol were thoracic epidural analgesia (activated before onset of surgery and discontinued on postoperative day 2-4), preoperative oral carbohydrate treatment (a carbohydrate-rich, clear beverage, Nutricia Preop [12.5 g/100 ml 1 carbohydrates, 12% monosaccharides, 12% disaccharides, 76% polysaccharides, 285 mosm/kg 1]; Nu- mico, Zoetermeer, the Netherlands) up until 2 hours prior to surgery, avoidance of preoperative oral bowel prepara- tion and perioperative fluid overloading. Early oral diet (4 hours after surgery) and early mobilization (2 hours out of bed on the day of surgery and then 6 hours daily) were also part of the protocol.

22 Primary endpoint

23 PEFR Hand grip strength Gut permeability C-reactive protein

24 Group A Group B Group C Group D (Placebo+Placebo (Active+Placebo (Placebo+Active (Active+Active ) ) ) ) Total number of complication by type Wound Infection 3 (10) 6 (19) 3 (9) 1 (4) Pneumonia 10 (33) 6 (19) 2 6 (19) 3,4 3 (11) Diarrhoea 1 (3) 0 (0) 0 (0) 1 (4) Septicaemia 1 (3) 1 (3) 2 (6) 1 (4) Anastamotic leak/dehiscence 3 (10) 1 (3) 4 (13) 1 (4) Intra abdominal collection 2 (7) 0 (0) 2 (6) 0 (0) Intestinal obstruction 0 (0) 1 (3) 0 (0) 1 (4) Ileus 2 (7) 4 (13) 3 (9) 3 (11) Stroke / TIA 1 (3) 0 (0) 0 (0) 0 (0) Thrombosis 1 (3) 0 (0) 0 (0) 0 (0) Congestive cardiac failure 2 (7) 5 (16) 0 (0) 3 (11) Myocardial infarction 1 (3) 1 0 (0) 2 (6) 0 (0) Renal failure 0 (0) 0 (0) 1 (3) 1 (4)

25 Group A Group B Group C Group D (Placebo+Placebo) (Active+Placebo) (Placebo+Active) (Active+Active) Number of patients with complications at day % (33 67%) 13 41% (25 58%) 13 42% (26 59%) 10 37% (21 56%) Total number of complications

26 Summary Intakes (even in trial setting) modest Pre + post confers metabolic benefit Difficult to tease out relative value of pre and post Possible impact on clinical outcomes

27 Peri-operative feeding Post-op systematic reviews suggest benefit Pre-op less data but also suggestive of benefit Peri-operative feeding integral part of ERAS Unclear what happens with regard to feeding Unclear if specific feeds confer additional benefit

28

29 Meta-analysis of Postoperative complications ERAS v Traditional care Enhanced recovery after surgery Kishna K Varadhan et al Clinical Nutrition 29(2010)

30 Meta-analysis of Length of stay. ERAS v Traditional care Enhanced recovery after surgery Kishna K Varadhan et al Clinical Nutrition 29(2010)

31 Structure Early postoperative enteral nutrition Perioperative enteral supplements and ERAS Perioperative optimization gum and immunofeeding Post discharge feeding Future studies

32 Gum chewing and post operative recovery (International Journal of Surgery 7 (2009) ) Time to flatus Time to stool Length of stay

33 Immunonutrition in gastrointestinal surgery length of post operative stay British Journal of Surgery Volume 98, Issue 1, pages 37-48, 7 OCT 2010

34 Immunonutrition in gastrointestinal surgery - post operative complications British Journal of Surgery Volume 98, Issue 1, pages 37-48, 7 OCT 2010

35 Immunonutrition in gastrointestinal surgery post operative complications Overall complications Post operative infection Pre op Pre op + post op Post op 0.48 (0.34 to 0.69) 0.39 (0.28 to 0.54) 0.46 (0.25 to 0.84) 0.36 (0.24 to 0.56) 0.41 (0.28 to 0.58) 0.53 (0.40 to 0.71) British Journal of Surgery Volume 98, Issue 1, pages 37-48, 7 OCT 2010

36 Immunonutrition in surgery for head and neck cancer Int. J. Oral Maxillofac. Surg. 2009; 38:

37 Immunofeed head and neck cancer and length of stay

38 Immunofeed head and neck cancer and risk of fistula or wound infection

39 hypothesized that inadequate gut function was the prime determinant of outcome rather than the mode of nutritional support per se. GSNs - substances with specific effects on gut function, morphology, ecoflora or physiology, over and above their roles as nutrient substrates on enteral tolerance Multivitamin capsules Probiotic capsules Prebiotic powder Oligofructose Glutamine

40 Placebo Intervention Time to tolerance (h) 214 ( ) 164 ( ) p=0 016 The primary outcome was the time to return of normal gut function. calculated in hours from the start of administration of study preparations to the oral/enteral tolerance of at least 80 per cent of calculated nutritional requirements for a minimum continuous period of 48 h Feed intolerance were determined by documented episodes of vomiting, feed aspiration, severe abdominal pain, distension or bloating that necessitated cessation or alteration to feed administration

41 A prospective multicentre observational study of 207 mixed ICU patients demonstrated that greater energy provision, by means of enteral feeding, was associated with a dose-dependent reduction in infectious complications (particularly after 96h of ICU admission) The findings highlight that the relationship between enteral feed tolerance and clinical outcome is worthy of further investigation.

42 Systematic Review of Postdischarge Oral Nutritional Supplementation in Patients Undergoing GI Surgery Results: Four studies were identified. Postdischarge supplements safe and increased energy intake, protein intake, and weight in patients after discharge from hospital. Little evidence was found that nutritional supplements reduce morbidity or improve quality of life, fatigue, or hand-grip strength. Conclusions: lack of robust data. It is recommended that nutritional supplements be offered to malnourished patients or those at high risk of poor dietary intake at discharge from hospital. Nutr Clin Pract :

43 Preoperative nutritional support There is no role for routine nutritional support in patients undergoing major surgery. Guidelines advocate preoperative nutritional support, preferably enteral, for patients at severe nutritional risk for 7 14 days prior to major surgery (grade A). Huhmann MB, August DA. Nutrition support in surgical oncology. Nutr Clin Pract 2009; 24: Weimann A, Braga M, Harsanyi L, et al. ESPEN Guidelines on enteral nutrition: surgery including organ transplantation. Clin Nutr 2006; 25:

44 Preoperative malnutrition

45 Preoperative malnutrition Cancer cachexia, chewing and swallowing impairments caused by the local tumour or by side effects from oncological treatment can result in malnourishment of head and neck cancer patients. A malnourished patient is at risk for increased morbidity and mortality. Severe malnutrition, defined as >10% weight loss, moderate malnutrition, defined as a weight loss of 5 10% no malnutrition, defined as a weight loss of less than 5%.

46 Preoperative malnutrition The relative risk of dying for a severely malnourished patient is 1.8 times higher than for patients without malnutrition.

47 Malnutrition and quality of life in patients treated for oral or oropharyngeal cancer Head & Neck Volume 33, Issue 4, pages , 7 SEP 2010 DOI: /hed

48 Future research How much feed are people getting/taking in practice? How important is nutrition in enhanced recovery? Are large clinical trials feasible or necessary?