Validation of ERAS interventional measures in elective gynecological surgery, for benign either malignant pathology.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
166
Optimization of relevant medical uncontrolled situations, avoid fasting, avoid bowel preparation, avoid premedications, nutritional assessment, stop smoking, stop alcohol and appropriate counselling
Blended anesthesia is mostly carried out using Total Intra Venous Anesthesia (TIVA) with loco regional analgesia, in particular Thoracic Epidural Anesthesia (TEA) in open surgery and spinal morphine or Transversus Abdominis Plane (TAP) block or quadratus lumborum block for laparoscopic surgical approach, associated to NSAIDs or acetaminophen; control of deep neuromuscular blocking with Train-of-four (TOF) stimulation avoiding residual paralysis. Multimodal prevention of PONV (according to preoperative assessment of Apfel Score) with a combination of multiple antiemetic drugs.
Federico Ferrari
Brescia, BS, Italy
Shorter Length Of Hospitalization (LOH)
Total amount of days spent in hospital
Time frame: Up to 4 weeks after surgery
Assessment of postoperative pain
NRS scale (from 0 to 10, 0 is no pain, 10 is maximum pain)
Time frame: At moment 0, 3, 6, 12 and 24 hours after surgery
Presence/Absence of nausea
Time frame: At moment 0, 3, 6, 12 and 24 hours after surgery
Presence/Absence of vomiting
Time frame: At moment 0, 3, 6, 12 and 24 hours after surgery
Anesthesiological complications
Rate measurement
Time frame: Up to 1 weeks after surgery
Time to bowel movement
Hours elapsed to event
Time frame: Up to 4 weeks after surgery
Time to flatus
Hours elapsed to event
Time frame: Up to 4 weeks after surgery
Time to hunger
Hours elapsed to event
Time frame: Up to 4 weeks after surgery
Time to drink
Hours elapsed to event
Time frame: Up to 4 weeks after surgery
Time to eating
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Postoperative pain control is obtained with opioid sparing strategies, in order to avoid Post Operative Ileus (POI) and PONV. According to the type of surgery TEA, TAP block , quadratus lumborum block or IT morphine is preferred. Patient is proposed to start drinking clear fluid 4 hours after surgery and to start eating the evening of the surgery, with the introduction of a normal free diet within 24 hours after surgery. It is proposed to chew gum three times daily for at least 15 minutes and eventually to use laxatives to promote a faster bowel function. Early mobilization is started from the evening of surgery.
Hours elapsed to event
Time frame: Up to 4 weeks after surgery
Time to walking
Hours elapsed to event
Time frame: Up to 4 weeks after surgery
Postoperative complications
Rate measurement
Time frame: Up to 9 weeks after surgery
Compliance to ERAS protocol
Rate measurement
Time frame: Up to 4 weeks after surgery
Validated questionnaires
QoR15
Time frame: Administered 24 hours after surgery and up to 4 weeks after surgery