The treatment of choice in advanced ovarian cancer is a cytoreductive surgery combined with chemotherapeutic treatment. This complex and aggressive surgery is associated with high postoperative complication rates that may result in a strong negative impact on the clinical results due to the delay with the start of adjuvant chemotherapy as well as the costs from the surgical process. Multimodal prehabilitation has emerged as an innovative intervention that focuses on optimizing physiological and psychological resilience to withstand the upcoming stress of surgery. It has been shown to reduce postoperative complications in major abdominal surgery, but has not been assessed yet in abdominal onco-gynecological surgery.
Main objective: To determine the efficacy of multimodal prehabilitation in decreasing postoperative complications in patients undergoing gynecological cancer surgery of high complexity by laparotomy (primary cytoreductive surgery, interval surgery and secondary cytoreductive surgery in advanced ovarian cancer). Design: Multicenter randomized controlled clinical trial. Subjects: 146 patients: 73 in the intervention group and 73 in the control group. Intervention group: PreHAB intervention consists on: 1. High-intensity endurance exercise training program and physical activity promotion remotely controlled with ICT (information and communications technologies). 2. Nutritional counselling to achieve protein intake of 1.5-1.8 g/kg and whey protein supplements. 3. Psychological coping. Control group will receive standard preoperative care. Both groups will receive perioperative care in accordance with the enhanced recovery after surgery (ERAS) guidelines. Measures: Aerobic capacity (incremental stress test), physical activity, operative complications and hospital length and associated costs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
146
1. High-intensity endurance exercise training program and physical activity promotion remotely controlled with ICT (information and communications technologies). 2. Nutritional counselling to achieve protein intake of 1.5-1.8 g/kg and whey protein supplements. 3. Psychological intervention including motivational interview, mindfulness meditation and cognitive behavioral therapy
Hospital Clinic Barcelona
Barcelona, Barcelona, Spain
Biomedical Research Institute la Fe
Valencia, Valencia, Spain
Incidence of postoperative complications
Any deviation from the normal postoperative course and according its severity to the Clavien-Dindo classification, will be considered a complication. A comprehensive complication index (CCI) scale will be used which assigns a value to each Clavein-Dindo level so a weighted average of the severity of complications can be calculated not only in a qualitatively way, but also numerically.
Time frame: 30 days
Hospital and ICU (intensive care unit) length of stay
Time frame: postoperative 30 days
Compliance to the ERAS program.
Percentage of items of ERAS program that were completed. Key aspects of this protocol include prevention of prolonged fasting allowing oral intake of clear fluids up to 2 hours before induction of anaesthesia, carbohydrate loading, avoidance of mechanical bowel preparation except if a bowel resection is scheduled, thromboprophylaxis; pre-, intra-, and post-operative euvolemia via goal directed fluid therapy, maintenance of normothermia, intraoperative and postoperative opioid-sparing multi-modal analgesia, avoidance the use of surgical drains, early removal of the urine catheter, and an emphasis on early ambulation and feeding.
Time frame: postoperative 30 days
Interval of days between surgery and the start of chemotherapy
Time frame: From date of surgery up to 6 months
Preoperative and postoperative aerobic capacity
Maximum production of carbon dioxide in ml/min during high intensity cardiopulmonar exercise.
Time frame: baseline, 1 and 3 month post intervention
Cost-effectiveness
Cost of treatment in the hospital in Euros including prehabilitation and postoperative recovery.
Time frame: Baseline up to 30 days after surgery
Health Related Quality of Life assesed by EORTC QLC-C30
Time frame: Baseline and 1 month postoperative
Incidence of cognitive deficit
Cognitive assessment based on validated neuropsychological test: T @ M (; Digits WAIS III (Wechsler Adult Intelligence Scale-Third Edition)
Time frame: Baseline and 1 month postoperative
Overall and disease-free survival of the study groups
Time frame: 5 years
Nutritional status
GLIM (includes hand-grip)
Time frame: Baseline and 1 month postoperative
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.