Ensayo clínico sobre la aplicación de protocolo de rehabilitación multimodal en pacientes con adenocarcinoma de endometrio sometidas a cirugía onco-ginecológica

Resumen

Introduction To date, there is a significant body of scientific evidence supporting the benefits of applying the enhanced recovery after surgery (ERAS) protocol. However, most studies have been conducted in the field of colorectal surgery, highlighting the need for new high-quality research in gynecology. This was the motivation for conducting the present clinical trial. Objectives The primary objective of our study was to assess whether there is a difference in the average hospital stay for oncological patients undergoing laparoscopic surgery for endometrial cancer following the multimodal rehabilitation protocol (ERAS) compared to the traditional protocol. The secondary objectives were to analyze whether this also leads to a decrease in perioperative morbidity and mortality, improvement in quality of life, and reduction in costs per patient. Methodology We conducted a randomized controlled clinical trial with two parallel groups, in which the intervention group was managed according to the multimodal rehabilitation protocol, and the control group received the traditional care previously provided at our hospital. A total of 34 patients were recruited for the intervention group and 34 patients for the control group. The ERAS protocol measures implemented included: preoperative counseling (lifestyle advice), prehabilitation (nutritional, anemia, and diabetes screening), avoiding mechanical bowel preparation, reducing preoperative fasting hours, allowing oral intake of liquids up to 2 hours before surgery, oral carbohydrate loading (Sugarmix), use of short-acting benzodiazepines, dual prophylaxis for postoperative nausea and vomiting (PONV), dual thromboembolic prophylaxis, shaving with a razor, antibiotic prophylaxis, avoiding the use of nasogastric tubes and drains, restrictive fluid therapy, maintenance of normothermia, multimodal analgesia (laparoscopic port infiltration and opioid-free ward analgesia), strict glycemic control, early oral intake, early mobilization, respiratory physiotherapy, and removal of the urinary catheter within the first 24 hours. Results Discharge from the hospital on the first day postoperatively was possible for 23 patients in the intervention group (67.6%) and 7 patients in the control group (20.6%), with this difference being statistically significant (p=0.000). This did not lead to a higher rate of complications, according to the Claiven and Dindo classification (p=0.645), but it did result in better pain scores according to the visual analogue scale (VAS) on day 3 (p=0.023) and day 10 postoperatively (p=0.041). There was no statistically significant difference in scores in the immediate postoperative period (p=0.693) and on day 30 postoperatively (p=0.566). The quality of life scores for the patients according to the EORTC QLQ-C30 scale were also better in the intervention group, with statistical significance at all stages. A cost analysis was performed considering only the average daily hospital stay cost, resulting in a savings of 851.97 euros per patient in the ERAS group. Conclusions The management of oncological patients undergoing laparoscopic surgery for endometrial cancer following the multimodal rehabilitation protocol (ERAS) reduces the average hospital stay, does not increase morbidity and mortality, improves the quality of life of patients, and reduces healthcare costs compared to the traditional protocol.