Fast Track Rehabilitation For Elective Colonic Surgery In Germany


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Fast Track Rehabilitation For Elective Colonic Surgery In Germany

  1. 1. Int J Colorectal Dis (2008) 23:93–99 DOI 10.1007/s00384-007-0374-z ORIGINAL ARTICLE “Fast-track” rehabilitation for elective colonic surgery in Germany—prospective observational data from a multi-centre quality assurance programme W. Schwenk & N. Günther & P. Wendling & M. Schmid & W. Probst & K. Kipfmüller & B. Rumstadt & M. K. Walz & R. Engemann & T. Junghans & “Fast-track” Colon II Quality Assurance Group Accepted: 26 July 2007 / Published online: 18 August 2007 # Springer-Verlag 2007 was high (epidural analgesia 86,6%, early oral feeding and Abstract Background The results of “Fast-track” colonic surgery in mobilisation on the day of surgery 85.5 and 85.4%). an unselected population outside of specialised units has Surgical morbidity was observed in 148 patients (14.1%) been unknown yet. and general morbidity in 95 patients (9.1%), while Materials and methods Data from 24 German hospitals mortality was 0.8%. Predefined discharge criteria were performing “Fast-track” rehabilitation as the standard peri- met within 5 (1–83) days after surgery, but because of operative care for patients undergoing elective colonic economical restraints in the German DRG system, patients resection were collected in a prospective multi-centre study were discharged only after 8 (3–83) days. Re-admission conducted between April 2005 and September 2006 to rate was 3.9%. Conclusion “Fast-track” rehabilitation for elective colonic evaluate local and general morbidity. Results One thousand and forty-seven patients undergoing resection was safe and feasible in German hospitals of all elective “fast-track” colonic resection were included. sizes and yielded a low general morbidity and re-admission Compliance to essential parts of “fast-track” rehabilitation rate. Post-operative recovery was enhanced, but discharge from hospital was delayed because of economical reasons. A complete list of all centres contributing patients to the “Fast-track” Colon II-Quality Assurance programme is given at the end of the manuscript. W. Schwenk (*) : N. Günther : T. Junghans K. Kipfmüller General-, Visceral-, Vascular- and Thoracic Surgery, Klinik für Allgemein- und Viszeralchirurgie, Charité Campus Mitte, Universitymedicine Berlin, Sankt-Marien Hospital, Charitéplatz 1, Mülheim an der Ruhr, Germany 10117 Berlin, Germany e-mail: B. Rumstadt Klinik für Allgemein- und Viszeralchirurgie, P. Wendling Diakoniekrankenhaus Mannheim, Chirurgische Klinik I, Krankenhaus Bad Soden, Mannheim, Germany Kliniken des Main-Taunus-Kreises GmbH, Bad Soden, Germany M. K. Walz Klinik für Chirurgie und Zentrum für Minimal Invasive Chirurgie, M. Schmid Klinikum Essen Mitte, Klinik für Allgemein- und Viszeralchirurgie, Essen, Germany Westpfalz-Klinikum GmbH Standort III Kirchheimbolanden, Kirchheimbolanden, Germany R. Engemann Chirurgische Klinik I Allgemein-, Viszeral- und Gefäßchirurgie, W. Probst Klinikum Aschaffenburg, Klinik für Allgemein- und Viszeralchirurgie, Aschaffenburg, Germany Ammerland Klinik GmbH, Westerstede, Germany
  2. 2. 94 Int J Colorectal Dis (2008) 23:93–99 Keywords Colonic resection . Peri-operative treatment . Materials and methods Multi-modal therapy . Morbidity . Hospital stay . Fast-track Study design The quality assurance programme “Fast- track” Colon II was designed as a prospective multi- centre study. German hospitals with surgeons known to Introduction perform “Fast-track” rehabilitation as standard care in Since the first multi-modal peri-operative clinical path- elective colonic surgery were invited to participate (see way based on the best scientific evidence available was Appendix). Between March 2005 and October 2006, 25 published by Kehlet et al in 1995 [1], “Fast-track” hospitals of all sizes from small hospitals in rural parts of rehabilitation or “ERAS” (“enhanced recovery after Germany to major university hospitals participated in the surgery”) was successfully adopted by several centres in quality assurance programme on a purely voluntary basis. the UK, Scandinavia and Germany [1–3]. All published Until October 2005, the total number of patients included “Fast-track” rehabilitation series achieved the same into this study was 1,047. After informed consent, all results: enhanced post-operative patient recovery, dimin- patients agreed to participate in this prospective study. ished post-operative fatigue, prevention of post-operative ileus and accelerated recovery with patients being dis- Peri-operative therapy Before hospitals were allowed to charged from hospital within 2 to 5 days after surgery [1, enter patients into this study, the chairman of each department provided detailed information on the “Fast- 3–6]. Most important, post-operative general morbidity was reduced from more than 20% under “traditional” peri- track” programme used. Information concerning peri- operative care [7–11] to 10% or less with “Fast-track” operative care was entered into a 15-page questionnaire rehabilitation [1, 3–7]. with 79 items covering pre-operative patient preparation, Critics of “Fast-track” rehabilitation may argue that all operative technique in conventional and laparoscopic reports of successful “Fast-track” programmes came from surgery, anaesthesia and analgesia, post-operative care, major specialised units and that implementation in smaller hospital discharge and re-admission. All chairmen also declared that “Fast-track” rehabilitation was the standard or less specialised units may be difficult if not impossible. To evaluate whether “Fast-track” rehabilitation for colonic peri-operative care programme in their department and resection can be applied to an unselected patient population agreed to enter all patients undergoing elective colonic outside of specialised centres, in 2005, a quality assurance surgery into the database. Details of the peri-operative programme (Qualitätssicherungsmaßnahme “Fast-track” II- clinical “Fast-track” pathway for elective colonic resection Kolon) was initiated in Germany. are given in Table 1. Table 1 Protocol for peri-operative “Fast-track” rehabilitation in elective colonic surgery in the German Quality Assurance Programme “Fast- track” Colon II Time Procedure Pre-operative Informed consent, discuss discharge on postoperative day 5-7 when feasible Intra-operative Non-opioid analgesia after induction of anaesthesia; thoracic combined EDA (LA/opioid; level Th6–Th8), transverse laparotomy when feasible, 5 trocar-laparoscopy or laparoscopic assisted procedure, avoid intraperitoneal drains, extract nasogastric tube at extubation Day of surgery Admit to regular nursing floor via PACU continuous EDA (LA/opioid), basal i.v. non-opioid analgesia, avoid systemic opioids, limit post-operative i.v.-fluids to 500 cm3; drink 1,500 cm3, if orthostatic dysregulation occurs add 500–1,000 cm3 of crystalloids i.v, 2 protein drinks; magnesium oxide 3×300 mg per day until first bowel movement; short walk outside of room, mobilized to chair for 2 h Post-operative day 1 Continuous EDA (LA/opioid), avoid systemic opioids, basal oral non-opioid analgesia, regular hospital food, drink >1,500 cm3; mobilized out of bed up to 8 h, walk outside of room twice; extract urinary catheter Terminate EDA in the morning, basal i.v. non-opioid analgesia, regular hospital food, drink >1,500 cm3; fully Post-operative day 2 mobilise from post-operative day 3 Continue as on day 2, until patient is discharged Post-operative day 8 (if already Outpatient clinic; extract skin staples; discuss result of histological examination, plan adjuvant therapy if discharged) needed EDA Epidural analgesia, LA local anaesthetics, PACU post-anaesthesia care unit, EDC epidural catheter, CVL central venous catheter
  3. 3. Int J Colorectal Dis (2008) 23:93–99 95 χ2 test or Fisher’s exact test. All continuous data are Peri-operative course Patients submitted to participating hospitals and scheduled for an elective colonic resection presented as median (range), and comparisons were per- were included into the prospective documentation. Exclu- formed according to the type of distribution using t test or sion criteria were emergency surgery or urgent operation Mann–Whitney U test. p values less than 0.05 were within 24 h after admission to the hospital, mechanic ileus, considered statistically significant. perforation or abscess with septic inflammatory response syndrome, age less than 18 years, pregnancy and patient refusal to participate in the prospective data collection. Results Indications to surgery as well as the surgical technique (laparoscopic or open) were at the surgeon’s discretion. For Patients, operative and peri-operative treatment From each patient, a standardised questionnaire containing 81 April 2005 to September 2006, 1,047 patients undergoing elective colonic resection with “Fast-track” rehabilitation items relating to epidemiological data, pre-operative risk assessment and concomitant diseases, peri-operative thera- were included. The number of participating hospitals py and post-operative course was completed. increased from 1 in April 2005 to 24 in September 2006. Post-operative morbidity included both general post- Detailed information concerning epidemiological data, operative complications and local (surgical) post-operative American Society of Anesthesiologists class, type of complications. General post-operative complications, surgery and operative technique are given in Table 2. Five recorded using the standard questionnaire, were pulmonary hundred and six patients underwent laparoscopic surgery complications (effusion, atelectasis), pneumonia (clinical or (48.3%) and 541 open resection (48.3). In university radiological diagnosis requiring physical and/or medical hospitals, 45.5% of all resections were performed lapa- therapy), cardiac complications (ischaemia, infarction, roscopically, compared to 51.1% of all resections in arrhythmia, heart failure requiring new or changed therapy), university-affiliated hospitals and 41.5% of resections in deep vein thrombosis of the lower extremeties (detected by non-academic hospitals (p=0.04). Tumour resections (n= sonography and/or venography), pulmonary embolism (di- 562, 53.6%) were the most common indication for surgery agnosed by computed tomography scan or scintigraphy), (58.0% in universities, 53.5% in university-affiliated hos- renal complications (increased retention values requiring a pitals, 51.0% in non-academic-hospitals; p=0.55). Open change in therapy) and urinary tract infection (positive surgery was performed in 435 of 562 tumour patients microbiology and clinical signs). Specific post-operative (77.4%; 72.6% university, 77.1% university-affiliated hos- complications recorded were haemorrhage (requiring either pitals, 79.8% non-academic hospitals; p=0.55) but only in any post-operative blood transfusion or re-operation), post- 106 (21.8%) of 485 patients with benign disease (p<0.01; operative ileus (requiring re-operation), paralytic ileus Table 2). Patients undergoing tumour resection were older (abdominal fullness and repeated vomiting requiring inser- (71.0 [16.5–95.0] years) and displayed a higher pre- tion of a nasogastric tube), wound healing impairment operative risk (ASA class III/IV=41.5%) than patients with (suspicious secretion, redness or pain in the wound requiring benign diseases (age=63.6 [26.2–95.0] years; ASA class surgical measures), anastomotic leakage (radiological find- III/IV=25.0%; each p<0.001). Because laparoscopic resec- ing and/or finding at re-operation), faecal fistula, diffuse tion was more often performed for benign disease, age and peritonitis, intra-abdominal or retrorectal abscess and stoma pre-operative risk were lower in laparoscopic patients (age= complications. Mortality rates were calculated based on 63.6 [16.5–94.7] years, ASA class III/IV=24.9%) than in deaths in hospital, including those that occurred within patients who underwent conventional surgery (age=70.6 30 days after discharge. [26.2–95.0] years, ASA class III/IV=41.7%; data not shown; each p<0.001). Sigmoidectomy and right hemicolectomy Data analysis and statistics accounted for most of the procedures (73.6%; Table 2). Epidural analgesia was provided to 907 of 1,047 patients All data were entered into the standardised questionnaire (86.6%), oral liquid feeding on the day of surgery was with each page signed by the surgeon responsible. While achieved in 895 patients (85.5%), and 720 patients (68.7%) original questionnaires remained in each hospital, carbon received regular food on post-operative day 1. Eight hundred copies were sent to the central office of the quality and ninety-four patients (85.4%) underwent mobilisation on assurance program at the Department of General-, Visceral-, the day of surgery. Three hundred and fifteen patients (30.1%) Vascular- and Thoracic Surgery of the Charité Campus Mitte did not receive any post-operative infusions, while infusion in Berlin. All data were entered into a relational database therapy lasted until postoperative day 1 in 382 patients (SPSS 10.0®; SPSS, Chicago, IL). Data analysis was (36.5%). Only 198 patients (18.9%) required any additional performed with SPSS 10.0 and SAS 9.1® (SAS Institute, intravenous fluids after day 1. Patients had their first post- Cary, NC). Categorical data were compared by applying the operative bowel movement on day 2 (0–11; Table 3).
  4. 4. 96 Int J Colorectal Dis (2008) 23:93–99 Table 2 Characteristics of Characteristics Values participating hospitals and in- cluded patient in the prospec- Hospitals (n=24) tive observational quality assurance programme “Fast- Number Percent University hospital 2 8 track” Colon II University affiliated teaching hospital 14 58 Non-academic hospital 8 33 Median Range Number of surgical beds 75 34–158 Number of patients included 41 3–206 Patients (n=1,047) Median Range age (years) 66 20–95 BMI (kg m−2) 26.0 15.4–52.2 Number Percent sex (female) 598 57.2 ASA class III/IV 354 33.8 Concomitant disease Cardiac 498 47.7 Hypertension 363 34.7 Pulmonary 135 12.9 Diabetes mellitus 122 11.7 Renal 51 4.9 Hepatobiliary 21 2.0 Operative technique Conventional 541 51.7 Laparoscopic 506 48.3 Indications for surgery 485a Benign disease 46.4 562b Tumour 53.6 Surgical procedure Sigmoidectomy 552 52.7 Right hemicolectomy 219 20.9 a Left hemicolectomy 94 9.0 106 (21.8%) open and 379 Extended hemicolectomy (left or right) 53 5.1 (78.1%) laparoscopic resections b 435 (77.4%) open and 127 Ileocecal resection 25 2.4 (22.6%) laparoscopic resections Other (i.e. segmental resection, bypass) 104 10.0 Table 3 Parameters of peri- Peri-operative treatment parameter (n=1047) operative treatment and post-operative recovery after Number Percent “Fast-track” colonic resection epidural analgesia 907 86.6 enforced mobilization Median Range 0–2 h on post-operative day 0 0–2 2–8 h on post-operative day 1 0–2 >8 h on post-operative day 2 1-2 Early oral feeding Liquid food on post-operative day 0 0-7 Solid food on post-operative day 1 0-7 i.v. fluids until post-operative day 1 0-43 First post-operative bowel movement on post-operative day 2 0-11 Number Percent Insertion of nasogastric tube post-operative? 52 5.0 Median Range Discharge criteria fulfilled on post-operative day 5 1–83 Discharged on post-operative day 8 1–83
  5. 5. Int J Colorectal Dis (2008) 23:93–99 97 Morbidity, mortality Local (surgical) morbidity was ob- epidural analgesia, early oral feeding and enforced mobi- served in 148 patients (14.1%), with superficial wound lisation on the day of surgery. While post-operative local morbidity was not increased (14.1%), “Fast-track” rehabili- healing impairment being the most common local compli- cation (n=67, 6.4%). Anastomotic leakage occurred in 29 tation achieved its main goal, to reduce the incidence of general complications from more than 20% with “traditional” patients (2.7%), and insertion of a nasogastric tube because of prolonged gastrointestinal dysfunction was indicated in care [7–11] to below 10% (9.1%). 53 patients (4.9%; Table 4). General morbidity was In Germany, Western Europe and the USA, peri- diagnosed in only 95 patients (9.1%). Cardiac complication operative treatment of patients undergoing elective colonic (n=32, 3.1%) was the most common general morbidity surgery is based on traditions rather than the best scientific (Table 4). In the post-operative course, eight patients evidence available [12]. Repeated audits among German (0.8%) died. Six deaths were related to local complications, surgeons demonstrated almost no change in peri-operative while two patients died because of general morbidity only therapy within the last decade of the twentieth century [13]. (pulmonary embolism, myocardial infarction). Furthermore, financial stimuli to improve peri-operative care with the aim of accelerated recovery and early Post-operative hospital stay and rate of re-admission Pre- discharge from the hospital have not been initiated in defined discharge criteria were met within 5 (1–83) days Germany so far. In fact, under the rules and regulations of after surgery, and patients were discharged after 8 (3–83) the German DRG system, a hospital stay of less than 5–7 days days. Forty-one patients (3.9%) were re-admitted 14 (5–35) for elective colonic resection will be punished by a reduced days after discharge for surgical (n=25; 2.6%) and/or reimbursement to the hospital [14]. Given these facts, it seemed very unlikely that “Fast-track” rehabilitation would be medical (n=17; 1.8%) reasons. introduced to German hospitals very fast. Recently, two major quality assurance programmes in Discussion Germany assessed the results of laparoscopic colorectal surgery (Laparoscopic Colorectal Surgery Study Group, This prospective multi-centre German quality assurance LCSSG [8, 15]) or conventional colorectal cancer surgery programme shows that “Fast-track” rehabilitation is feasible (Working Group Colon/Rectum Carcinoma, WGCRC [7, in an unselected group of patients admitted to elective 10]). Both quality assurance programmes were purely colonic resection. Compliance with the “Fast-track” regimen voluntary and performed a prospective data acquisition was high, with more than 85% of all patients receiving from patients undergoing colorectal surgery. There was no Table 4 Local and general Total (n=1,047) morbidity, mortality after elec- tive “Fast-track” rehabilitation Number Percent for elective colonic resection Surgical complications Patients 143 13.7 Incidents Subcutaneous wound infection 67 6.4 Anastomotic leakage 29 2.8 Bleeding (re-operation) 21 2.0 Fascial dehiscence 11 1.1 Ileus (re-operation) 5 0.5 Small bowel lesion 2 0.3 General complications Patients 95 9.1 Incidents Cardiac 32 3.1 Pulmonary 27 2.6 Renal 20 1.9 Neurological/psychiatric 19 1.8 Urinary tract 14 1.4 Catheter related 3 0.3 Hepatic 3 0.3 Mortality 8 0.8
  6. 6. 98 Int J Colorectal Dis (2008) 23:93–99 to a “Fast-track” rehabilitation can be high in a broad range on-site monitoring, and indications for surgery as well as the surgical technique used were at the responsible of hospitals and (3) general morbidity after elective colonic surgeon’s discretion. “Fast-track” Colon II was based on surgery is markedly reduced in “Fast-track”-rehabilitated the same principles: voluntary participation and evaluation patients. We therefore conclude from the results of the of “everyday” clinical practice in participating German “Fast-track” Colon II quality assurance programme that hospitals. However, in contrast to “Fast-track” Colon II, “Fast-track” rehabilitation is safe and feasible in elective LCSSG and WGCRC databases described the results of a colonic surgery and can be initiated in every hospital “traditional” peri-operative treatment. Considering these provided that surgeons, anaesthetists and the nursing staff conditions, laparoscopic colonic resection in 1,311 LCSSG are willing to adhere to a pre-defined clinical pathway, patients (age=64 [38–94] years; no ASA classes given), based on the best scientific evidence available. yielded an 14.6% of local and 10.9% of general complica- tions [8], while our 506 laparoscopic “Fast-track” patients Acknowledgement Data collection within the Quality Assurance Program “Fast-track” Colon II was funded (in alphabetical order) by: displayed a local morbidity of 10.3% and a general Astra Zeneca Germany, Fresenius Germany, Karl Storz Endoskope morbidity of only 5.7%. For open cancer surgery in 2,293 Germany, Pfizer Germany, Pfrimmer/Nutricia Germany and Tyco WGCRC patients (age=69 [18–96] years, ASA class III/IV= Healthcare Germany. 46.3%), local morbidity was 21.8%, and general morbidity was 26.9% [7], whereas local and general morbidity of 435 conventional “Fast-track” tumour patients were 16.8 and 11.4%. Appendix In summary, general morbidity was reduced by 47 and 59% in “Fast-track” Colon II compared to LCSSG and WGCRC. Addendum Overall post-operative hospital stay was longer (8 days) in the “Fast-track” colon II patients than in other “Fast-track” The following surgeons and hospitals participated in the series published in the literature (2–5 days) [6, 16–19]. “Fast-track” Colon II registry by providing at least one Nevertheless, pre-defined discharge criteria were fulfilled patient: within 5 days after surgery, and discharge of most of the 1. P. Wendling, Kliniken des Main-Taunus-Kreises patients would have been possible at this time. Many of the GmbH, Krankenhaus Bad Soden surgeons involved in this prospective study decided to prolong 2. R. Engemann, Klinikum Aschaffenburg post-operative hospital stay to 6–8 days because of econo- 3. M. Schmid, Westpfalz-Klinikum GmbH Standort III mical reasons. The German DRG system includes the unique Kirchheimbolanden feature of a so-called lower border of hospital stay that will 4. W. Probst, Ammerland Klinik GmbH, Westerstede penalise early discharge of patients after surgery. According to 5. K. Kipfmüller, Sankt-Marien Hospital, Mühlheim an the G-DRG2007, resection of a sigmoid cancer (MDC06 der Ruhr Diseases of the Alimentary tract; G18Z: Procedure concerning 6. J. M. Müller Charité Campus Mitte, Berlin small or large bowel or G02Z Procedures concerning the 7. B. Rumstadt, Diakoniekrankenhaus, Mannheim small or large bowel with complexity or lower border of hospital stay: 4–5 days) will be reimbursed with €7,221.− to 8. M. K. Walz, Klinikum Essen Mitte, Essen € 9,898.− (Base rate=€2,860.−, relative weight=2.525 or 9. K. Nagel, Marienhospital, Aachen 10. J. Gönninger, Klinikum Minden 3.461). Given these basic parameters for reimbursement, in 11. K. Schönleben, Klinikum der Stadt Ludwigshafen our own experience [3], discharge of patients 4–5 days after 12. B. Vetter, St. Elisabeth-Krankenhaus, Lörrach elective colonic resection may reduce revenues to the hospital by up to €1,500.− per case—a considerable and economically 13. H.-P. Meyer, Hunsrück Klinik Kreuznacher Diakonie, Simmern inacceptable loss. It is of notice, however, that compared to 14. B. Rehnisch, Klinikum des Landkreises Löbau-Zittau LCSSG and WGCRC data (post-operative hospital stay=11.5 gGmbH, Zittau and 15 days, respectively), post-operative hospital stay of 15. H.-W. Krawzak, Klinikum Niederberg, Velbert laparoscopic FTCII patients (7 days) as well as conventional 16. C.-T. Germer, Klinikum Nürnberg FTCII cancer patients (9 days) was reduced by 40%. 17. A. Hirner, Universitätsklinikum Bonn Prospective uncontrolled cohort studies, as the one 18. M. Varney, Städtisches Klinikum Gütersloh presented here, are impaired by numerous types of bias 19. D. Ockert, Krankenhaus der Barmherzigen Brüder, and therefore justifiably marked with a low level of Trier evidence and a low grade of recommendation [20]. 20. V. Paolucci, Ketteler Krankenhaus, Offenbach However, three facts may not pass unnoticed from this data: (1) “Fast-track” rehabilitation in elective colonic 21. M. Kahle, St. Elisabeth-Krankenhaus, Bad Kissingen 22. A. Trupka, Klinikum Starnberg surgery is feasible outside of the centres, (2) compliance
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