NCT03347409

Validation of an ERAS Protocol in Gynecological Surgery

Validation of an ERAS Protocol in Gynecological Surgery: an Italian Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 166 (actual)
• Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Validation of ERAS interventional measures in elective gynecological surgery, for benign either malignant pathology.

Conditions

• Surgery
• Hysterectomy
• Gynecologic Disease
• Gynecologic Cancer
• Anesthesia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-06-14
• Primary completion: 2019-07-14
• Completion: 2019-12-15
• First posted: 2017-11-20
• Last updated: 2020-02-07

Locations

1 site across 1 country: Italy