Validation of an ERAS Protocol in Gynecological Surgery

NACompletedINTERVENTIONAL
Enrollment

166

Participants

Timeline

Start Date

June 14, 2017

Primary Completion Date

July 14, 2019

Study Completion Date

December 15, 2019

Conditions
SurgeryHysterectomyGynecologic DiseaseGynecologic CancerAnesthesia
Interventions
OTHER

Changes 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

OTHER

Changes 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.

OTHER

Changes 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.

Trial Locations (1)

25123

Federico Ferrari, Brescia

All Listed Sponsors
lead

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

OTHER

NCT03347409 - Validation of an ERAS Protocol in Gynecological Surgery | Biotech Hunter | Biotech Hunter