Adherence to an enhanced recovery protocol in colorectal surgery before and during a structured implementation – a prospective cohort study from nine German hospitals

Structured fast-track implementation

In all hospitals, structured implementation of an enhanced recovery protocol (ERP) was carried out according to the same scheme [13]. After the status quo of perioperative management had been determined an interdisciplinary enhanced recovery team consisting of nurses, surgeons and anesthetists was formed. Enhanced recovery nurses (ERP-nurses) were selected from the nursing staff to coordinate the interventions, care for the ERP patients, and collect clinically relevant perioperative management data [14]. The ERP team was trained in a workshop. Afterwards, the ERP and the necessary documents were created in a 3-month planning phase (preERP). Then the ERP protocol was used in the clinics from a fixed cut-off date. After 3 and 6 months of ERP use, workshops were held in the clinics in which the protocol was customized according to the special needs of each hospital. 12 months after the initial workshop, and 9 months after using the enhanced recovery protocol in the clinical routine, the ERP implementation was completed. At this time point, all clinics achieved the pre-defined targets for successful structured ERP implementation: ERP adherence >75 %, patient autonomy regained ≤5 days, postoperative length of stay <6 days, general complications <10 %.

Patient population, inclusion and exclusion criteria

The data of all patients ≥18 years of age who were admitted for elective colorectal resection from the beginning of the structured implementation form the basis of the present data analysis. Patients who underwent multivisceral resections (i.e. small bowel, partial bladder resection, hysterectomy, partial vaginal resection or atypical resection of liver metastasis) were also included in the data collection. Patients who required emergency (<6 h after initial presentation) or urgent (6–24 h after initial presentation) surgery were excluded. Furthermore, patients scheduled for cytoreductive surgery with or without intraoperative hyperthermic chemotherapy, for pelvic exenteration including en bloc rectal resection with cystectomy (i.e., for recurrent rectal cancer) or simultaneous anatomical resection of liver metastasis were excluded. Furthermore, patients who did not consent to collection of their perioperative data were also excluded. Neither age, nor gender, indication for surgery, concomitant disease or risk factors were exclusion criteria. The structured implementation of the ERP is not a clinical study, but rather a quality assurance and improvement measure in everyday clinical practice. All perioperative and surgical procedures used are well established and represent standard procedures. Approval by an ethics committee was therefore not required. However, all patients signed an informed consent form for participation and data collection.

Traditional treatment

During the planning of the fast-track treatment pathway (preERP), the established perioperative treatment for elective colorectal resections was not changed. During the initial workshop as well as in the subsequent video conferences, the treatment teams were encouraged not to change the existing perioperative treatment until the planning was completed.

Enhanced recovery treatment

Optimized multimodal perioperative management was assessed according to international recommendations [15]. Following these recommendations, there were clear targets for 23 enhanced recovery elements (Table 1). To assess the progress of ERP implementation, the process was divided into 3 phases:

1. The start of the ERP application and the first customization workshop after 3 months (0–3 months; ERP3);

2. The first and second customization workshop (3–6 months; ERP6); and

3. The second adaptation workshop and the end of implementation (6–9 months; ERP9).

Postoperative complications

Adverse events that deviated from the unremarkable postoperative course until 30 days after discharge from hospital were considered complications and classified as general medical, local surgical and anesthesiologic complications. Any secondary procedure under anesthesia was documented as reoperation.

Functional recovery

To describe functional recovery, the following were documented and analyzed: Interval between surgery and removal of the urinary catheter, tolerance of solid oral food, first bowel movement, regaining physical autonomy, and discharge from hospital. Autonomy was defined as the achievement of all the following goals: 1. reaching preoperative level of mobilisation (fully mobile, on crutches, wheelchair), 2. tolerance of oral food, passing stool, no i. v. fluids, 3. no nausea or vomiting, 4. getting dressed without help, 5. no i. v. analgesics.

Data collection and analysis

Epidemiological data, disease, concomitant diseases, data on perioperative management, surgery and anesthesia, intra- and postoperative complications, and data on functional recovery as well as patients’ length of stay were prospectively collected in a pseudonymized manner. Data collection was carried out by ERP-nurses in the Interactive Fast-track Audit SysTem (INFAST^®, GOPOM GmbH Düsseldorf) in the database management system Ninox^® (Ninox GmbH, Berlin). Adherence to the 23 fast-track elements ranged from 0 (none of the 23 elements utilized) to 100 (all 23 elements utilized) in each patient. Fast-track adherence was calculated for all patients as well as for each hospital. Statistical analysis of anonymized data was done in SAS-Studio^® (SAS Institute Inc., Cary NC, USA). Categorical data were tested for group differences using the chi2 test and Fisher’s exact test where appropriate. Continuous parameters are expressed as median (5th–95th percentiles) and group differences are analyzed with the t-test or Wilcoxon rank-sum test after testing for normal distribution.

Patients and operative procedures

A total of 556 (48.3 %) women and 597 (51.7 %) men were treated, of whom 387 (33.6 %) were assigned to ASA classes III and IV. The average age was 66 (60–76) years and 644 (55.9 %) of the operations were performed to treat malignant diseases. Type of disease (benign vs. malign), type of resection (colonic vs. rectal) operative access (open vs. laparoscopic) are given in Table 2. The patients in the pre-ERP, ERP3, ERP6 and ERP9 groups did not differ in terms of gender, ASA classification, type and localization of the disease (Table 2). The age of the ERP3 patients was slightly higher than that of the other four groups (Table 2; p<0.03). 67.7 % of the preERP group underwent laparoscopic surgery, compared with 85.0 % of patients in the ERP9 group (Table 2; p<0.001).

Adherence to fast-track elements

In the preERP phase, adherence to the 23 recommended ERP elements was 52 (48–57) % overall. Intraoperative adherence was higher at 71 (71–86) % than preoperative adherence at 56 (44–67) % and postoperative adherence was lowest at 29 (14–43) % (Table 3, Figure 1). ERP adherence increased most significantly in the first 3 months of clinical implementation, rising to 78 (74–87) %, with the largest adherence increase achieved in the preoperative phase (+33 %), while intraoperative adherence increased by 15 % and postoperative adherence by 26 % (Table 3, Figure 2). Over the next 3 months, overall adherence increased by a further 6 % (Figure 1). Preoperative and intraoperative adherence remained constant at 89% and 86 % respectively, while postoperative adherence increased by 14–71 % (Table 3, Figure 2). From ERP6 to ERP9, preoperative and intraoperative adherence remained stable at a very high level, while postoperative adherence increased by a further 4–87 % and thus accounted for most of the final overall adherence increase (Table 3, Figures 1 and 2).

Figure 1:

Adherences to ERP protocol before (preERP) and during months 0–3 (ERP3), 3–6 (ERP6) and 6–9 (ERP9) of ERP implementation.

Figure 2:

Adherences to pre-, intra-, and postoperative ERP protocol elements before (preERP) and during months 0–3 (ERP3), 3–6 (ERP6), and 6–9 (ERP9) of ERP implementation.

Adherence to individual ERP elements

Figure 3a–c show a radar chart of adherence to the 23 ERP elements mentioned in the chronological perioperative course. PreERP, adherence only reached very high values for some elements of intraoperative management (e.g. iv. antibiotics and maintenance of normothermia). In contrast, postoperative adherence targets for early nutrition and early mobilization were not achieved in any patient (Figure 3a). In the first 3 months of ERP-use, there was a particularly strong increase in pre-admission and pre-operative adherence (e.g. nutritional screening and therapy, patient education, and metabolic conditioning with carbohydrate-rich drinks before surgery) and a few post-operative elements were also better implemented (Figure 3a). However, infusion therapy, rapid nutrition, and early mobilization continued to pose major challenges. Further improvements were observed for individual preoperative elements after 6 months (e.g. oral antibiotics, carbohydrate loading, and non-sedating premedication). Adherence to important elements was also increased postoperatively (e.g. infusion therapy, nutrition, and mobilization). Even at this time, only a few postoperative ERP elements achieved adherence of more than 75 % (Figure 3b). After a further 3 months, the use of the preoperative ERP elements has stabilized at a very high level (>85–90 %). During this period, further progress was made in the particularly demanding elements of infusion therapy, early nutrition, and rapid mobilization. Nevertheless, targets for mobilization and nutrition were still only achieved in less than half of the patients (Figure 3c).

Figure 3:

Changes in adherence to each element of the ERP protocol a.) before and during months 0–3 of ERP implementation; b.) during months 0–three and 3–6 of ERP implementation and c.) during months 0–3 and 6–9 of ERP implementation.

Morbidity and mortality

In 338 of the 1,153 patients, a complication occurred in the postoperative course up to 30 days after discharge (29.3 %). These were local surgical complications in 254 patients (22.0 %) and general medical complications in 130 cases (11.3 %). While there was no difference in the frequency of wound infections, anastomotic leaks or bleeding, the incidence of postoperative ileus (preventing oral feeding or requiring the insertion of a nasogastric tube) was higher in the ERP group (13.3 %) than in the pre-ERP group (4.5 %; p<0.01). Paralytic ileus was more frequently observed in the ERP9 than in the ERP6 or ERP3 period. Furthermore, there were no significant differences in the frequency of general complications. A total of 84 patients (8.9 %) underwent a second procedure due to complications, 95 (8.2 %) patients had to be readmitted to hospital within 30 days of discharge and seven patients (0.6 %) died after the elective procedure. There were no significant differences in the incidence of these adverse events between the preERP and ERP patients and no significant differences were found between the preERP, ERP3, ERP6 and ERP9 groups (Table 4).

Functional recovery and length of stay

The functional recovery of the patients was significantly faster in the ERP3, ERP6 and ERP9 groups than in the pre-ERP patients (Table 5). After just 3 months of ERP application patients showed a significant acceleration of postoperative recovery in all areas, and this continued in the ERP6 and ERP patients (Table 5).

The duration of patient mobilization from bed increased most significantly in the first 3 months of ERP application. However, a continuous increase in mobilization performance was shown after 6 and 9 months of ERP (Table 5, p<0.001). Due to the faster recovery, ERP patients could be discharged one day earlier (ERP3, ERP6) and finally two days earlier (ERP9) than preERP (p<0.001).