Validation of an ERAS Protocol in Gynecological Surgery

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

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

Conditions
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Surgery, Hysterectomy, Gynecologic Disease, Gynecologic Cancer, Anesthesia

Intervention / Treatment
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* Other: Changes in preoperative care
* Other: Changes in intraoperative care
* Other: Changes in postoperative care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Perioperative (SP) care<br> | |
| Experimental: ERAS protocol<br> | Other: Changes in preoperative care<br>* Optimization of relevant medical uncontrolled situations, avoid fasting, avoid bowel preparation, avoid premedications, nutritional assessment, stop smoking, stop alcohol and appropriate counselling<br>Other: Changes in intraoperative care<br>* 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.<br>Other: Changes in postoperative care<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shorter Length Of Hospitalization (LOH) | Total amount of days spent in hospital | Up to 4 weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of postoperative pain | NRS scale (from 0 to 10, 0 is no pain, 10 is maximum pain) | At moment 0, 3, 6, 12 and 24 hours after surgery | 
| 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 | Rate measurement | Up to 1 weeks after surgery | 
| Time to bowel movement | Hours elapsed to event | Up to 4 weeks after surgery | 
| Time to flatus | Hours elapsed to event | Up to 4 weeks after surgery | 
| Time to hunger | Hours elapsed to event | Up to 4 weeks after surgery | 
| Time to drink | Hours elapsed to event | Up to 4 weeks after surgery | 
| Time to eating | Hours elapsed to event | Up to 4 weeks after surgery | 
| Time to walking | Hours elapsed to event | Up to 4 weeks after surgery | 
| Postoperative complications | Rate measurement | Up to 9 weeks after surgery | 
| Compliance to ERAS protocol | Rate measurement | Up to 4 weeks after surgery | 
| Validated questionnaires | QoR15 | Administered 24 hours after surgery and up to 4 weeks after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ERAS, Fast-track surgery, gynecology