Anesthesia, Gynecologic Cancer, Gynecologic Disease, Hysterectomy, Surgery
Conditions
Keywords
ERAS, Fast-track surgery, gynecology
Brief summary
Validation of ERAS interventional measures in elective gynecological surgery, for benign either malignant pathology.
Interventions
OTHERChanges in preoperative care
Optimization of relevant medical uncontrolled situations, avoid fasting, avoid bowel preparation, avoid premedications, nutritional assessment, stop smoking, stop alcohol and appropriate counselling
OTHERChanges in intraoperative care
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.
OTHERChanges in postoperative care
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.
Sponsors
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age \>18 and \<75 years old * Patients candidated for elective gynecological surgery for benign pathology * Patients with diagnosis of gynecological neoplasm and candidated for elective gynecological surgery * Signed consent form * Karnofsky Performance Status \> 70
Exclusion criteria
* ASA score \> 3 * Contraindication to loco-regional anaesthesia * Patients with ileus or subocclusive condition prior surgery * Coagulation disorders * Organ failure or severe disfunction (heart, renal, pulmonary, hepatic) * Uncontrolled hypertension (\>180/95) * Alcohol or drug abuser (current or previous) * Unability to self-care (PFS \< 70) * Comorbidity-Polypharmacy Score \> 22 * Psychiatric condition or language barriers * Planned Intensive Care Recovery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Shorter Length Of Hospitalization (LOH) | Up to 4 weeks after surgery | Total amount of days spent in hospital |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Presence/Absence of nausea | At moment 0, 3, 6, 12 and 24 hours after surgery | — |
| Presence/Absence of vomiting | At moment 0, 3, 6, 12 and 24 hours after surgery | — |
| Anesthesiological complications | Up to 1 weeks after surgery | Rate measurement |
| Time to bowel movement | Up to 4 weeks after surgery | Hours elapsed to event |
| Time to flatus | Up to 4 weeks after surgery | Hours elapsed to event |
| Time to hunger | Up to 4 weeks after surgery | Hours elapsed to event |
| Assessment of postoperative pain | At moment 0, 3, 6, 12 and 24 hours after surgery | NRS scale (from 0 to 10, 0 is no pain, 10 is maximum pain) |
| Time to eating | Up to 4 weeks after surgery | Hours elapsed to event |
| Time to walking | Up to 4 weeks after surgery | Hours elapsed to event |
| Postoperative complications | Up to 9 weeks after surgery | Rate measurement |
| Compliance to ERAS protocol | Up to 4 weeks after surgery | Rate measurement |
| Validated questionnaires | Administered 24 hours after surgery and up to 4 weeks after surgery | QoR15 |
| Time to drink | Up to 4 weeks after surgery | Hours elapsed to event |
Countries
Italy
Outcome results
None listed