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Fast Track Rehabilitation For Elective Colonic Surgery In Germany
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: wolfgang.schwenk@charite.de 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. 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. 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. 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. 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. 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
7. Int J Colorectal Dis (2008) 23:93–99 99
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