Abstract
Aim: To gather standardized information of current perioperative management of gynecological oncology patients and to evaluate up to what extent the Enhanced Recovery after Surgery (ERAS) elements are established in the clinical routine of gynecologic oncology units in Germany. Materials and Methods: We performed a multi-centric nationwide survey among 654 primary, secondary and maximal health care gynecological departments in Germany. A multiple-choice questionnaire based on the principles of ERAS was developed to gather information about perioperative management of two fictional cases in gynecological oncology. Results: One hundred four units (22%) have been taken the survey. Only 49.5% of surveyed hospitals claimed to be adherent to more than 70% of ERAS elements in managing perioperative period of primary cytoreductive surgery in ovarian cancer patients. 21% of these hospitals implemented more than 80% and only 8.4% implemented more than 90%. The results in border-line tumors operations did not differ from those of ovarian cancer operations. Conclusion: The implementation of ERAS elements in gynecologic oncology in Germany is still not satisfying as only half of the departments will now be able to apply 70% of these principles. Therefore, we plan the second step of this survey in order to be able to build a consistent structured reporting platform between gynecological oncology units in Germany to facilitate the wide implementation and standardization of ERAS protocol.
The Enhanced Recovery after Surgery (ERAS) program refers to a number of perioperative interventions aiming to attenuate surgical stress by maintaining normal physiology to the best possible extent, thus leading to enhanced recovery after major surgeries and to shorten the hospital stay (1-4).
This concept has originally been reported in the 1990s by Henrik Khelet and colleagues (5-6) and was first established in colorectal surgery. Because of positive results without additional morbidity or mortality, ERAS has been implemented in other surgical fields, such as orthopedics, thoracic surgery, urology and gynecology (7-9).
The ERAS strategy involves, among others, preoperative patient education and counseling, reduction of preoperative fasting, omission of bowel preparation, thromboembolism prophylaxis, antimicrobial prophylaxis, preventing intraoperative hypothermia, perioperative euvolemia, prevention of postoperative nausea and vomiting, limited use of nasogastric tubes and drains, early removal of urinary catheters, aggressive multimodal analgesia to minimize opiate consumption, early postoperative mobilization and early enteral nutrition (10).
Despite the fact that there is a great consensus by clinicians that the implementation of the ERAS approach is beneficial for the patients with various entities, there is so far no validated single protocol for patients with gynecological and non-gynecological surgeries (11). Furthermore, there are very limiting data on the current status of the implementation of the ERAS approach in the departments of gynecology that are treating patients with malignant ovarian tumors. Therefore, in order to provide valid documentation, this German survey was conducted.
Materials and Methods
We performed a multi-centric nationwide survey among 654 primary, secondary and maximal health care gynecological departments in Germany. A multiple-choice questionnaire based on the principles of ERAS was developed to gather information about perioperative management of two fictional cases in gynecological oncology. The questions were selected based on a review of all relevant publications about ERAS and fast-track surgery by an interdisciplinary and interprofessional team with high experience on this field (gynecological oncologists (JS and MZM), anesthesiologists (AF), nurses, statistician (RR)). This project was adopted from NOGGO (Nord-Ostdeutsche Gesellschaft für Gynäkologische Onkologie-Arbeitsgemeinschaft Gynäkologische Onkologie=North-Eastern-German Society of Gynaecological Oncology) and AGO (Arbeitsgemeinschaft Gynäkologische Onkologie Society of Gynecological Oncology) and was undertaken from the Young Academy of Gynecologic Oncology (JAGO).
The first case reflected an advanced primary ovarian cancer with expected bowel resection, whereas the second case presented a borderline tumor with no assumptive bowel surgery.
The first case represented a 53-year-old postmenopausal patient in good physical condition with clinical evidence of advanced ovarian cancer (AOC) like massive amount of ascites and signs of bowel involvement. Cancer antigen (CA)-125 was assumed to be 863 U/ml, human epididymis protein 4 (HE4)=34 pmol/l, risk of ovarian cancer malignancy algorithm (ROMA) index=62.9%. Apart from mild hypertension, there was no history of co-morbidities or previous surgery. In this case, an extended primary cytoreductive surgery aimed to complete tumor resection with lymphadenectomy, peritonectomy, ometectomy, bowel resection and end-to-end anastomosis had to be performed.
The second case represented a 39-year-old premenopausal patient in good physical condition with a suspect 24 cm solid-cystic abdominal mass. Intraoperatively, a tumor with low malignancy potential (LMP) was found. The surgery, in this case, assumed to include bilateral adnectomy, hysterectomy, peritoneal biopsy, omentectomy and cytology (CA 125=137 U/ml, HE4=45 pmol/l, ROMA score=6.71%).
The questionnaire was divided into two parts: the first part included questions regarding the health institution and the second part was designed to gather information on perioperative clinical management of the fictional cases regarding the ERAS elements.
The questions covered principles of ERAS concept, such as performance of preoperative bowel preparation, duration of preoperative fasting and onset of thrombosis prophylaxis, as well as performance and time of antimicrobial prophylaxis. The intraoperative aspects were focused on assessment if antiemetic prophylaxis was performed, if hypothermia was avoided, if restrictive fluid balance was used. The postoperative aspects included time of enteral re-feeding, time of nasogastric tube removal, bladder catheters and abdominal drains removal, time of mobilization, length of hospital stay.
In a pilot phase 10 physician were interviewed to confirm understanding and feasibility of this questionnaire.
The categorical data were presented as absolute counts with percentages and evaluated be means of Chi-square test or Fisher's exact test. The adjusted effect of factors, such as number of treated cases and level of medical care on length of the hospital stay, was tested in a logistic regression model.
The implementation of ERAS guidelines was estimated by calculation a score system, including key items of pre-, intra- and postoperative ERAS recommendations.
Results
One hundred forty-four (22%) from the 654 addressed gynecological departments have been taken part in the survey: 37% were primary health care units, 40% were hospitals of secondary health care and 23% were hospitals of maximal health care.
One third of the departments were certified as gynecological oncological centers and the majority of the certified hospitals were units of maximal health care. More than 90% of all departments followed their own standard operating procedures (SOPs). About two-thirds of the participating maximal-care hospitals and more than a third of second-care participating hospitals were certified as oncological gynecological centers.
The implementation of ERAS principles was compared for all cases between the three types of hospitals. Table I describes the management of the ovarian cancer case and Table II the management of the LMP patient.
There were no major differences between the departments regarding the perioperative care of gynecological malignancies. More than 90% of the departments perform a bowel preparation before surgery for patients with ovarian cancer. In contrast, in the case of the LMP patient, only 72% of the departments would perform a bowel preparation.
Approximately, two thirds of the hospitals maintain a fasting period more than 6 h for fluids and more than 12 h for solid food before surgery.
Almost 80% of patients after ovarian cancer surgery will begin with fluid re-uptake within the first 6 h after surgery and for the majority of ovarian cancer patients the first solid meal will be offered after 24 h. For the LMP patient, more than 90% of the hospitals will begin with fluid re-uptake within the first 6 h after the surgery and the first solid meal will be after 24 h.
The majority of ovarian and LMP patients will receive an epidural anesthesia before the surgery and the average time to remove the epidural catheter will be the third day after surgery. Nonsteroidal anti-inflammatory drugs (NSAIDs) were combined with opioids in most of cases for pain control after the surgery for both types of patients.
Almost all participants will apply a single dose antibiotic prophylaxis before the surgery. More than two thirds of all addressed departments will restrict the fluid uptake under 2 liters at the day of surgery and more than 90% will use postoperative nausea and vomiting (PONV) and hypothermia prevention in case of extended ovarian cancer surgery.
The departments differ significantly in respect of application of nasogastric intubation with highest rates of patients who received a nasogastric intubation at the hospitals of maximal care. The nasogastric tubes are removed significantly earlier at the hospitals of maximal care.
The majority of participating departments will apply abdominal drains at the surgery and only one third of them will remove the drains in case of ovarian cancer surgery within 3 days.
One third of hospitals will begin the postoperative mobilization directly at the day of surgery, in case of ovarian cancer surgery. For the LMP case, 60% of hospitals will begin the postoperative mobilization at the day of surgery.
The average hospital stay after ovarian cancer surgery is 9 to 11 days and 2 days shorter after LMP surgery.
In case of primary cytoreductive surgery by ovarian cancer, the number of treated patients, status of medical care and certification for oncological center were not significant factors influencing long hospital stay in multivariate analysis. In a score analysis developed in this study depending on the most important 10 ERAS elements (bowel preparation, duration of preoperative fluids fasting, duration of preoperative fasting for solid food, nasogastric intubation, antimicrobial prophylaxis, PONV and hypothermia prophylaxis, time of fluids re-uptake after surgery, time of food re-uptake after surgery, time of mobilisation after surgery) in order to evaluate the degree of ERAS elements implementation in each hospital, we found that only 49.5% of surveyed hospitals claimed to be adherent to more than 70% of ERAS elements in managing perioperative period of primary cytoreductive surgery in ovarian cancer patients. Twenty-one percent of these hospitals implemented more than 80% and only 8.4% implemented more than 90% of ERAS elements. The results in borderline tumors operations did not differ from those of ovarian cancer operations (50% implemented more than 70% of elements, 23.5% implemented more than 80%).
Discussion
De Groot et al. (9) concluded, in 2014, that, after several years of practicing ERAS in colorectal surgery, spontaneous spread of ERAS principles to gynecologic oncology surgery occurred partially. However, the results of his study also underscored the need for a structured and supported pro-active process to implement the ERAS program in a complete and successful way in gynecological oncology.
Investigators studying the application of ERAS principles to colonic resections have acknowledged the difference between intra-abdominal large-bowel resections and pelvic surgery. Pelvic intestinal resections are fraught with higher complication rates, longer hospital stay and unique complications not seen in abdominal surgery (12). This makes the spontaneous adaption of ERAS protocol in gynecological oncology, and especially in extended pelvic resections like the exenteration operation of locally advanced cervical cancer or the cytoreductive operations of ovarian cancers, very challenging.
Despite the fact that some of the ERAS principles, such as the use of antimicrobial prophylaxis (97.9% in ovarian cancer patients and 96.5% in borderline tumor patients) are widely practiced among the gynecological departments in Germany, very limited number of hospitals seems to implement the principles of ERAS in their routine.
Gustafsson et al. (13) concluded that the proportion of adverse postoperative outcomes (30-day morbidity, symptoms and readmissions) was significantly reduced with increasing adherence to the ERAS protocol (>70%, >80% and >90%) compared with low ERAS adherence (<50%). This dose-response relationship seems to be minimal after implementation of more than 70% of ERAS elements, which means that each surgical unit has to implement at least 70% of ERAS elements to aim the enhanced recovery effect of this program.
Our study showed that about half of German hospitals already implemented more than 70% of the ERAS elements. We know from other studies that a major challenge in healthcare is to incorporate innovations into routine clinical practice. Many innovations require an intensive, well-planned approach to become widely adopted (14, 15).
In this term, it seems a good base to know that already 50% of German hospitals show a high adherence score to ERAS elements. This encouraged us to start a second step of this survey to ask the hospitals with high adherence score to send us the documentations of perioperative management of at least 5 consecutive gynecological oncological patients who underwent ERAS program, in order to be able to build a consistent structured reporting platform between gynecological oncology units in Germany and facilitate a wide implementation and standardization of ERAS protocol in Germany. Whether the implementation of ERAS principles is related with improved outcome after gynecologic surgery is still to be answered in prospective randomized trials.
Footnotes
↵* These Authors contributed equally to this study.
NOGGO-AGO, Nord-Ostdeutsche Gesellschaft für Gynäkologische Onkologie-Arbeitsgemeinschaft Gynäkologische Onkologie (North-Eastern-German Society of Gynaecological Oncology- Society of Gynecological Oncology).
Conflicts of Interest
No financial or personal conflict of interest by any of the Authors to declare.
- Received May 24, 2016.
- Revision received June 20, 2016.
- Accepted June 22, 2016.
- Copyright© 2016 International Institute of Anticancer Research (Dr. John G. Delinassios), All rights reserved