FT SURGERY IN SPAIN: ON THE WAY TO IMPLEMENTATION?

Department Colorectal Surgery ZARAGOZA UNIVERSITY HOSPITAL. SPAIN FT SURGERY IN SPAIN: ON THE WAY TO IMPLEMENTATION? JOSE-M RAMIREZ, MD, PhD Zaragoza. Spain

Anaesthesiologist Gen. Surgeon Vasc. Surgeon Cardiac surgery Orthopedic surgery Neurosurgery

Section of Colorectal Surgery (1993) Protocol for Colorectal Cancer 1998 Up-dated (Laparoscopic surgery): 2001 2004 2006 2.006: 141 patients (Mean age 69 (43-89)) *NBCAP (21.356 cases) * National Bowel Cancer Audit Project. ACPGBI. Report 2007 Post-op. Mortality (<30 days) Permanent Stoma rate (PSR) Length Hospital stay (mean days) 4% 29,6 10 <5% 28,3 <12

Fast Track protocol Enhanced recovery program Enhanced surgical treatment

FAST-TRACK SURGERY : Structured pathway Evidence-Based Surgical Care and the Evolution of Fast-Track Surgery Henrik Kehlet, Douglas W. Wilmore. Ann Surg 2008;248: 189–198 Mortality Morbidity Hospital stay =

Hospital Do Mexoeiro. Vigo Hospital de Calahorra Hospital Universitario Zaragoza Hospital Mutua de Terrasa. Hospital General de Valencia Hospital Universitario de Elche Hospital Son Llatzer. Mallorca Hospital Clínico de Madrid Hospital Greg. Marañón. Madrid Hospital La Paz. Madrid Complejo Hospitalario La Mancha Madrid, April 2008 >400 <400 >900 >400 >400 <400 <400 >900 >900 >900 <400

AIMS: What are our pre-fast track colorectal surgery results? ¿What are the difficulties to implant a FT program? Once implanted. Degree of Protocol compliance Outcome of the protocol. To offer others our knowledge and experience. Spanish Working Group In Fast-Track Surgery

11 Centres Control Group: Retrospective Study (Six months) Prospective Study: Intention to treat Inclusion criteria: Colorectal cancer Open or Laparocopy Older than 18 y.o. Exclusion criteria: ASA IV Ostomy Previous CRT

According to the Best available evidence we will: Preoperative Counseling. Informed consent signed No bowel preparation 4 CHR (Nutricia preop) drinks on the day before No Sedation 2 CHR (Nutricia preop) 3 h. before surgery Prophylactic PONV medication Epidural anesthesia Oxigenation Prevention of Hypothermia Goal-directed fluidotherapy (Cardio-Q) NO Nasogastric tube NO drains Early mobilization Early oral liquids

ON LINE. RECORDING DATA SYSTEM

April June Starting point Working plan November First audit 100 patients Hospital Do Mexoeiro. Vigo Hospital de Calahorra Hospital Universitario Zaragoza Hospital Mutua de Terrasa. Hospital General de Valencia Hospital Universitario de Elche Hospital Son Llatzer. Mallorca Hospital Clínico de Madrid Hospital Greg. Marañón. Madrid Hospital La Paz. Madrid Complejo Hospitalario La Mancha 10 5 15 10 15 5 5 15 10 10 5

April November Involved Hospital. Hospitals Including data 62 patients

Preoperative Counseling. Informed consent signed No bowel preparation 4 CHR (Nutricia preop) drinks on the day before No Sedation 2 CHR (Nutricia preop) 2 h. before surgery Prophylactic PONV medication Epidural anesthesia Oxigenation Prevention of Hypothermia Goal-directed fluidotherapy (Cardio-Q) NO Nasogastric tube NO drains Early mobilization Early oral liquids ¿What are the difficulties to implant a FT program?

CIRUGIA COLO-RECTAL PROGRAMA DE REHABILITACIÓN PRECOZ INFORMACIÓN ÚTIL

BASSE L, HJORT JAKOBSON D ET AL. A clinical pathway to accelerate recovery after colonic resection. Ann Surg 2000: 232: 51-57 BASSE L, THORBOL J E.ET al. Colonic surgery with accelerated rehabilitation or conventional care. Dis Colon Rectum 2004; 47:271-278. GRIEF R, AKCA O ET AL. Supplemental perioperative oxygen to reduce the incidence of surgical wound infection. Outcomes Research Group. N Engl J Med 2000; 342: 161-167 GUENAGA KF, MATOS D, CASTRO AA ET AL. Mechanical bowel preparation for elective colorectal surgery. Cochrane database Syst Rev 2003; (2) CDOO1544 KEHLET H, DAHL J B. Anaesthesia, surgery, and challenges in postoperative recovery. Lancet 2003; 362: 1921-1928 KEHLET H, WILMORE D W.. Multimodal strategies to improve surgical outcome. Am J Surg 2002; 183: 630-641. LINDGREN P G, NORDGREN S R ET AL. Midline or transverse abdominal incision for right sided colon cancer-a randomized trial. Colorectal Dis 2001;3: 46-50 LJUNGQUIST O, NYGREN J, THORELL A. Modulation of post-operative insulin resistance by pre-operative carbohydrate loading. Proc Nutr Soc 2002; 61: 329-336. MERAD F, HAY J M ET AL. Is prophylactic pelvic drainage useful after elective rectal or anal anastomosis? A multicenter controlled randomized trial. French Association for Surgical Research. Surgery 1999; 125: 529-535 MONAGLE J ET AL 2003. ANZ J Surg 2003 RATNARAJ J, KABON B ET AL. Supplemental oxygen and carbon dioxide each increase subcutaneous and intestinal intramural oxygenation. Anesth Analg 2004; 99: 207-211 WILMORE DW, KEHLET H. Recent advances: management of patients in fast track surgery. BMJ 2001; 322: 473-476 FEARON KCH, LJUNGQVIST O., VON MEYENFENFELDT M, et al. Enhanced recovery after surgery: a consensus review of clinical care for patients undergoing colonic resection. Clinical Nutrition 2005; 24: 466-477 SCHWENK W, NEUDECKER J, RAUE W, et al. Fast track rehabilitation after rectal cancer resection. Int J Colorectal Dis 2006; 21: 547-553.

AIMS What are our pre-fast track colorectal surgery results? Retrospective study Hospital Clínico de Zaragoza 36 Hospital Universitario de Elche 21 Hospital General Universitario de Valencia 27 Hospital La Mancha Centro - Alcázar de San Juan 21 Hospital Universitario La Paz 28 Hospital Mutua de Tarrasa 23 Hospital Do Maxoeiro - Vigo 24 Hospital Fundación de Calahorra 27 Hospital de Igualada 21 Hospital de Alzira 22 TOTAL 240

Patient Characteristics (September 2009) Overall morbidity: 37% Mean Stay: 13 days ± SD. 13,731 (4-40) Restrospective N=240 Mean Age 65,1(43-89) ASA I-II III 65% 35% Gender Males 64% Laparoscopy 41% Type operation Right hemicolectomy Sigmoid resection Rectal resection Subtotal/total resection Other 25% 34% 24% 8% 9% W. Infection Bleeding Death ileus anastomotic leak

Outcome of the protocol AIMS Prospective (Intention to treat) study Hospital Clínico de Zaragoza 77 Hospital Universitario de Elche 8 Hospital General Universitario de Valencia 52 Hospital San Llatzer de Palma de Mallorca 7 Hospital La Mancha Centro - Alcázar de San Juan 16 Hospital Clínico San Carlos 26 Hospital Mutua de Tarrasa 14 Hospital Do Maxoeiro - Vigo 20 Hospital Fundación de Calahorra 14 Hospital de Igualada 10 TOTAL 234

Protocol outcome Restrospective N=240 Prospective N=234 p Mean Age 65,1(43-89) 67,1 (38-89) ns ASA I-II III 65% 35% 70% 30% ns Gender Males 64% Males 60% Laparoscopy 41% 54% P=0.06 Type operation Right hemicolectomy Sigmoid resection Rectal resection Subtotal/total resection Other 25% 34% 24% 8% 9% 36% 27% 20% 6% 11% ns

Mean Stay: 7 days (3-45) Prospective Study Overall morbidity: 28 %

Protocol outcome Restrospective N=240 Prospective N=234 p Mean Age 65,1(43-89) 67,1 (38-89) ns ASA I-II III 65% 35% 70% 30% ns Gender Males 64% Males 60% Laparoscopy 41% 54% P=0.06 Mor bidity Hospital stay Re-admision 37% 13 days 2% 28% 7 days 3,5% P: 0.06 P<0.05 ns

Preoperative Counseling 95% No bowel preparation 90% 4 CHRich Drinks day before 92% No Sedation 90% 2 CHRich Drinks 2 h. before surgery 60% Prophylactic PONV medication 75% Epidural anesthesia 55% Hiperoxigenation 67% Goal-directed Fluids (Cardio-Q) 45% No hypothermia 70% No NG tube 80% No drains 78% Early mobilization 70% Early oral intake (fluids) 49% AIMS Degree of accomplishment (June 2009 -189 patients) Per patient: 8,4 out of 14 evaluated items

Preoperative Counseling 100% 95% No bowel preparation 95% 90% 4 CHRich Drinks day before 95% 92% No Sedation 87% 90% 2 CHRich Drinks 2 h. before surgery 75% 60% Prophylactic PONV medication 80% 75% Epidural anesthesia 50% 55% Hiperoxigenation 70% 67% Goal-directed Fluids (Cardio-Q) 72% 45% No hypothermia 75% 70% No NG tube 72% 80% No drains 72% 78% Early mobilization 80% 70% Early oral intake (fluids) 56% 49% Degree of Protocol Compliance in FT patients per evaluated modality June 2009 Oct. 2008 A Logistic Regression study Degree of Protocol compliance

Preoperative Counseling 95% No bowel preparation 90% 4 CHRich Drinks day before 92% No Sedation 90% 2 CHRich Drinks 2 h. before surgery 60% Prophylactic PONV medication 75% Epidural anesthesia 55% Hiperoxigenation 67% Goal-directed Fluids (Cardio-Q) 45% No hypothermia 70% No NG tube 80% No drains 78% Early mobilization 70% Early oral intake (fluids) 49% Recommended Recommended Recommended Recommended Recommended Recommended Degree of Protocol compliance Highly recommended Highly recommended Highly recommended Highly recommended Mandatory Mandatory Mandatory Mandatory

To offer knowledge and experience. AIMS

Anaesthesiologist General surgeon Vascular surgeon Cardiac surgeon Orthopedic surgeon Neuro-surgeon

FT SURGERY IN SPAIN: ON THE WAY TO IMPLEMENTATION?

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FT SURGERY IN SPAIN: ON THE WAY TO IMPLEMENTATION?