Introduction/Background The implementation of perioperative care pathways such as the Enhanced Recovery After Surgery (ERAS) program can improve the quality of healthcare in complex operations such as the multivisceral surgery for patients with ovarian cancer. Adherence to individual ERAS-items is essential for effective treatment. One ERAS-item is the preoperative carbohydrate intake (CHO), which is associated with the reduction of postoperative insulin resistance and improved clinical outcomes. Methodology The KORE INNOVATION is an ongoing clinical trial to assess the effects of an innovative multimodal perioperative care pathway consisting of prehabilitation combined with an ERAS-pathway to reduce complications for patients undergoing surgery for ovarian cancer. Preoperative carbohydrate loading (CHO) is given to the patients using a complex carbohydrate drink (CCD). Patients receive two bottles of CDD the evening before and one bottle of CDD two hours prior to surgery and are instructed by a specialized KORE nurse to self-administer the bottles. Results 378 patients were included in the preliminary, descriptive analyses. 191 patients (50.5%) consumed the full dose of CHO (3 bottles CDD), while 258 (68.3%) patients consumed at least one bottle. 67.7% of patients consumed CHO in the evening before the operation and 58.5% in the morning of the operation. Pre-existing diabetes was a contraindication and was present in 5.8%. Reasons for not consuming CHO were: not received from staff (4.8%), refusal by patient (0.5% in the evening, 1.6% in the morning), poor taste of CDD (1.9% in the evening, 4% in the morning). Conclusion The main reason for non-adherence to the CHO rejection of the CDD due to the poor taste according to the patients. Through patient empowerment by education and self-monitored ingestion, logistical factors (e.g. CDD not received) could be avoided and adherence could be increased. Disclosures KORE INNOVATION is funded by the Innovationsfinds des Gemeinsamen Bundesausschuss (GBA), 01NVF18021.
With growing knowledge about ovarian cancer over the last decades, diagnosis, evaluation and treatment of ovarian cancer patients have become highly specialized, and an individually adapted approach should be made in each woman by interdisciplinary cooperation. The present study aims to show the variety and extent of medical specialties involved at our institution according to the European Society of Gynecologic Oncology (ESGO) Quality indicators (QI). A woman, diagnosed with high-grade ovarian cancer, International Federation of Gynecology and Obstetrics (FIGO) class IVb was selected for a single case observational study. The observation period (total = 22d) comprised preoperative diagnostic procedures, including imaging, the in-patient stay for cytoreductive surgery, and the postoperative course and case discussion at our interdisciplinary tumor board. Data were obtained by self-reporting and by patient file review. Patient tracking demonstrated an interdisciplinary cooperation of 12 medical specialties [62 physicians (63
Background Advanced ovarian cancer is managed by extensive surgery, which could be associated with high morbidity. A personalized pre-habilitation strategy combined with an ‘enhanced recovery after surgery’ (ERAS) pathway may decrease post-operative morbidity. Primary Objective To analyze the effects of a combined multi-modal pre-habilitation and ERAS strategy on severe post-operative morbidity for patients with ovarian cancer (primary diagnosis or first recurrence) undergoing cytoreductive surgery. Study Hypothesis A personalized multi-modal pre-habilitation algorithm entailing a physical fitness intervention, nutritional and psycho-oncological support, completed by an ERAS pathway, reduces post-operative morbidity. Trial Design This is a prospective, controlled, non-randomized, open, interventional two-center clinical study. Endpoints will be compared with a three-fold control: (a) historic control group (data from institutional ovarian cancer databases); (b) prospective control group (assessed before implementing the intervention); and (c) matched health insurance controls. Inclusion Criteria Patients with ovarian, fallopian, or primary peritoneal cancer undergoing primary surgical treatment (primary ovarian cancer or first recurrence) can be included. The intervention group receives an additional multi-level study treatment: (1) standardized frailty assessment followed by (2) a personalized tri-modal pre-habilitation program and (3) peri-operative care according to an ERAS pathway. Exclusion Criteria Inoperable disease or neoadjuvant chemotherapy, simultaneous diagnosis of simultaneous primary tumors, in case of interference with the overall prognosis (except for breast cancer); dementia or other conditions that impair compliance or prognosis. Primary Endpoint Reduction of severe post-operative complications (according to Clavien– Dindo Classification (CDC) III–V) within 30 days after surgery. Sample Size Intervention group (n=414, of which approximately 20% insure with the participating health insurance); historic control group (n=198); prospective control group (n=50), health insurance controls (for those intervention patients who are members of the participating health insurance). Estimated Dates for Completing Accrual and Presenting Results The intervention phase started in December 2021 and will continue until June 2023. As of March 2023, 280 patients have been enrolled in the intervention group. The expected completion of the entire study is September 2024. Trial Registration NCT05256576 .
Acculturation and acculturative stress are potential risk factors for adverse perinatal outcomes. This study investigates whether and how acculturative stress affects preterm birth (PTB) in a sample of migrant women in Berlin. We interviewed 955 women who recently gave birth using standardized questionnaires (Frankfurt Acculturation Scale and Acculturative Stress Index). Multivariable logistic regression analyses assessed the effects of acculturation and acculturative stress on PTB. Women with migrant backgrounds did not have significantly higher PTB rates than German natives. First-generation migrants experienced higher acculturative stress levels than second-generation migrants, 38.8% vs. 13.2%. Acculturative stress could not be identified as a risk factor for PTB in our sample. These results need to be considered in the context of an international city and the wide use of antenatal care services in our population, which could be responsible for similarly good perinatal outcomes and highlights the potential of good access to perinatal care for vulnerable groups.
Introduction/Background Preferred treatment for ovarian cancer is a primary debulking surgery associated with surgical stress and high levels of morbidity. Implementing the Enhanced Recovery After Surgery (ERAS) pathway has shown improved postoperative outcomes. However, preoperative screening for risk factors and optimization of general health status is not widely implemented, even though they could increase postoperative reconvalescence by improving baseline health status. Patient's compliance is critical for a successful implementation, which makes understanding their perspective valuable. We report preliminary results of patients' perspective on prehabilitation. Methodology As part of our ongoing clinical trial, we implement an innovative multimodal perioperative care pathway consisting of a trimodal prehabilitation in combination with the established ERAS pathway for ovarian cancer patients undergoing primary debulking surgery. The trimodal prehabilitation consists of a personalized, targeted nutrition-, physical fitness-, and mental health intervention, following a comprehensive baseline assessment. At the end of prehabilitation, before undergoing surgery, patients are asked about their perspective on prehabilitation by a closed questionnaire. Results Data of 131 patients were available for preliminary analysis. When asked which part of prehabilitation was most supportive, 53% reported the overall package, 36% physical activity, and 12% the nutrition intervention to be most helpful. 11% felt most supported by the mental health coaching, and only 4% did not feel supported by prehabilitation. Furthermore, 40% reported feeling more physically capable after prehabilitation, vs. 56% who felt the same, and 4% felt less physically capable. Furthermore, 59% reported feeling mentally strengthened by prehabilitation, 37% reported the same level as before, and only 3% reported feeling worse. Conclusion Preliminary results suggest that patients seem to respond well to a trimodal prehabilitation program. The overall package seems best received, followed by physical fitness and nutrition advice. A lot of patients report feeling physically more capable, as well as mentally strengthened after prehabilitation. Disclosures KORE-INNOVATION is funded by the 'Innovationsfonds' of the 'Gemeinsamer Bundesausschuss' (01NVF18021)
This analysis aimed to describe the psychological stress in patients with ovarian cancer prior to radical surgery, with a particular focus on age. The National Comperhensive Cancer Network (NCCN) Distress Thermometer (DT) was administered to 150 women undergoing surgery for ovarian cancer last week prior to surgery. We compared our data, which is a subanalysis from the “Role of Predictive Markers for Severe Postoperative Complications in Gynecological Cancer Surgery” (RISC-Gyn)-Trial with a multicenter epidemiological study as a control group, including 1913 female cancer patients from Germany. Overall, 150 patients with ovarian cancer were enrolled, of which 126 patients (82.4%) with advanced-stage disease International Federation of Gynecology and Obstetrics (FIGO III–IV), and 55 patients (37%) ≥65 years. Younger patients reported more fears, worries, and sadness and wished to be more involved in treatment decisions. Worries were three times more frequently reported by patients with a university degree. These patients had more emotional problems such as fears, worries, sadness, and nervousness than the control group. Sustainable psychological support and professional advice in school, work, and financial management could help ovarian cancer patients reduce their stress factors especially the younger women under the age 65. Empowering patients by involving them in treatment decisions seems to be one of the crucial issues we need to address in our future clinical work.
Background: Despite the key role of optimized fasting in modern perioperative patient management, little current data exist on perioperative fasting intervals in routine clinical practice. Methods: In this multicenter prospective study, the length of pre- and postoperative fasting intervals was assessed with the use of a specifically developed questionnaire. Between 15 January 2021 and 31 May 2022, 924 gynecology patients were included, from 13 German gynecology departments. Results: On average, patients remained fasting for about three times as long as recommended for solid foods (17:02 ± 06:54 h) and about five times as long as recommended for clear fluids (9:21 ± 5:48 h). The average perioperative fasting interval exceeded one day (28:23 ± 14:02 h). Longer fasting intervals were observed before and after oncological or extensive procedures, while shorter preoperative fasting intervals were reported in the participating university hospitals. Smoking, treatment in a non-university hospital, an increased Charlson Comorbidity Index and extensive surgery were significant predictors of longer preoperative fasting from solid foods. In general, prolonged preoperative fasting was tolerated well and quality of patient information was perceived as good. Conclusion: Perioperative fasting intervals were drastically prolonged in this cohort of 924 gynecology patients. Our data indicate the need for better patient education about perioperative fasting.
Introduction/Background Patient empowerment is an essential, yet neglected resource of the patient’s health journey. Through a patient-centered approach, patients are encouraged to take on an active role in their health and recovery. We report our first experiences of the patient walk intervention as part of the patient empowerment module, which is embedded in the KORE-INNOVATION trial as a subpopulation analysis. Methodology The KORE-INNOVATION trial is an ongoing clinical trial to assess an innovative perioperative care pathway to reduce complications for patients undergoing surgery for ovarian cancer. We implemented the patient walk intervention to encourage patients‘ autonomy before surgery. Patients were given the option to walk to the operation room instead of being pushed in their bed as part of the standard patient care pathway. The only requirement for walking was to omit sedating pre-medication. To evaluate patients‘ and staff’s experiences, we administered a questionnaire between the 2nd-5th postoperative day. Results Of the 65 patients offered to walk to the operating room, 48 participated. All patients reported that the experience was either better than expected or as expected; nobody reported that it was worse than expected. Patients reported that if given the choice would walk again. Patients also stated that they felt strengthened in their autonomy. Reasons for not walking were refusal to omit sedatives or anxiety before the operation. The main barriers from the staff’s perspective were logistical difficulties, which decreased over time. Conclusion Providing patients with the option to walk to the operating theatre is a simple but effective method of increasing patients’ autonomy and engagement. Furthermore, it promotes the active patient role in their health and recovery. This easily implementable no-cost intervention should be routinely integrated in the context of ERAS protocols.
Introduction/Background The effectiveness of prehabilitation in improving physical capacity for patients undergoing surgery has been shown for patients in orthopedic, abdominal, or cardiological surgeries. Ovarian cancer patients have an exceptionally high risk for severe postoperative complications due to the extent of the surgical treatment, often including multi-visceral resection. We report our first experiences of implementing a tri-modal prehabilitation intervention as part of the KORE-INNOVATION trial. Methodology KORE-INNOVATION is an ongoing clinical trial to implement and assess an innovative perioperative care pathway to reduce complications (primary endpoint) for patients undergoing surgery for ovarian cancer through the implementation of a prehabilitation strategy combined with the ‘enhanced recovery after surgery’ (ERAS)-pathway. The prehabilitation intervention consists of three modules: a personalized empowerment intervention, a personalized physical exercise-program-, and a personalized metabolic screening and nutrition intervention. Before prehabilitation, a complex baseline assessment, consisting of the Fried frailty assessment, metabolic and physical assessments, and detailed patient history, is performed to develop a personalized prehabilitation plan targeting individual deficits (figure 1). Results Prehabilitation ranged from one to three weeks and was overseen by a multi professional and interdisciplinary KORE team of physicians, nurses, physiotherapists, and nutritionists. The majority of patients conducted prehabilitation as outpatients. Weekly phone calls were made to monitor patients’ adherence and adjust treatment plans, if necessary. Patients reported feeling more capacitated and resilient after undergoing the prehabilitation program. Conclusion A structured, individualized prehabilitation program delivered through a specialized multi professional team presents an opportunity to prepare patients holistically for the stressful experience of debulking surgery and might contribute to faster postoperative reconditioning. Prehabilitation is an important addition to the ERAS pathway and should be considered a relevant part of perioperative care.
Introduction/Background Ovarian cancer is primarily diagnosed in advanced stages, and thus far, no sensitive screening is available. Therefore, in newly diagnosed patients, treatment and evaluation have become highly specialized, and an individually adapted approach should be made in each case by interdisciplinary cooperation. The present study aims to display the variety and extent of medical specialities and personnel resources involved in today’s therapy algorithm to efficiently treat patients with advanced ovarian cancer following a patient‘s journey. Methodology A patient diagnosed with ovarian carcinosarcoma FIGO IIIb was selected for a single case observational study. The period under observation (total=22d) compromised preliminary evaluation, outpatient imaging, the in-patient stay for cytoreductive surgery and ended with the postoperative case discussion at our interdisciplinary tumor conference. Data were obtained by self-reporting and by patient file review. As part of standard care, multidisciplinary evaluation and treatment were performed. Results Patient-tracking demonstrated an interdisciplinary cooperation of 12 medical specialities (n=62 physicians; men n=39, 62,7%; women n=23, 37,3%), 8 different types of nursing staff (n=59; men n=13, 22%; women n=46, 78%) and 9 different types of peri-operative/administrativ staff (n=23; men n=4, 17,4%; women n=19, 82,6%) with a total number of n=144 individuals. Interaction with the patient was furthermore divided into direct contacts (n=199; 76%) and indirect contacts (n=63; 24%), without face-to-face interaction, with a total number of n=262 patient-oriented contacts. Conclusion Modern treatment of advanced ovarian cancer requires multidisciplinary medical therapy, a holistic patient-centered approach and close dialogue as a team in specialized hospitals. The present study demonstrates the diversity of physicians, medical staff and interdisciplinary teamwork that is implemented in the evaluation and treatment of a single patient and underlines the need for a structured multiprofessional communication algorithm.
Introduction/Background The perioperative ERAS pathway has been established in many surgical fields and has shown to improved health care quality and costs. We report our first experiences implementing the ERAS pathway as part of the KORE INNOVATION trial in patients with ovarian cancer. Methodology KORE INNOVATION is an ongoing clinical trial to assess the effects of an innovative perioperative care pathway to reduce complications for patients undergoing surgery for ovarian cancer by implementing a prehabilitation strategy combined with an ERAS pathway. The trial is conducted at two study sites in Germany, both ESGO centers of excellence for ovarian cancer surgery: Charité Universitätsmedizin Berlin and Evangelische Kliniken Essen Mitte. ERAS guidelines were adapted for the clinical settings, and multiple training sessions for all staff were conducted. An interdisciplinary ‘KORE-team’ consisting of physicians, nurses, nutritionists, and physiotherapists was established to aid implementation, monitor staff adherence, follow the patients throughout the entire care process, and function as interface managers. We report our first experiences with the staff’s adherence to ERAS items at both study sites. Results The following ERAS items showed good adherence: omission of bowel preparation, carboloading, disinfection using chlorhexidine, use of opioid-sparing anesthesia and epidurals, early postoperative mobilization, and feeding. In contrast, the following items showed decreased adherence: omission of pre-operative sedatives, omission of drains, goal-oriented fluid management during the postoperative phase, and the omission of postoperative antibiotic treatment. Adherence increased through monitoring through daily rounds and active staff engagement administered by the KORE team. Conclusion Continuous training and adherence monitoring are by multi professional and interdisciplinary KORE team are key factors for the successful implementation of the ERAS pathway.