Enhanced Recovery After Surgery (ERAS) in Gynecological Surgery (ERASGS-01)

Study Overview
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Brief Summary
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Enhanced recovery programs are composed of preoperative, intraoperative and postoperative strategies combined to form a multi-modal pathway. ERAS requires a multidisciplinary team of anesthetists, surgeons and nurses for successful implementation and realization of its advantages.The aim of this study is to compare outcomes of conventional perioperative care with those of an enhanced recovery after surgery (ERAS) perioperative care plan in women undergoing surgery for gynecologic cancer or suspected gynecologic disease.

Detailed Description
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The study design is a two-arm, randomized, controlled trial. The control arm will consist of standard conventional perioperative care. The intervention arm will consist of a protocol-driven ERAS program. The investigators believe that this information will be very useful because although there is a national interest in creating ERAS protocols for gynecology, there currently is very little published on the subject. Investigators hypothesize that those patients randomized to the ERAS protocol will have shorter lengths of hospital stay and complications, without increasing readmission rates. The investigators would like to publish the investigators' results and protocol as a resource for other institutions to adopt.

Official Title
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A Prospective, Randomized Trial Comparing ERAS and Conventional Protocol for Perioperative Care of Patients After Gynecological Surgery

Conditions
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Gynecologic Disease, Gynecologic Cancer

Intervention / Treatment
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* Procedure: ERAS protocol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >18 and <70 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 Exclusion Criteria: 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) Psychiatric condition or language barriers Planned Intensive Care Recovery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Conventional Perioperative (SP) care<br>Conventional Perioperative (SP) care | |
| Experimental: ERAS protocol<br>preoperative / intraoperative/ postoperative management | Procedure: ERAS protocol<br>* preoperative management Optimization of relevant medical uncontrolled situations, avoid fasting, avoid bowel preparation, avoid premedications, nutritional assessment, stop smoking, stop alcohol and appropriate counselling intraoperative management Multimodal prevention of prophylaxis against nausea and vomiting (PONV) (according to preoperative assessment of Apfel Score) with a combination of multiple antiemetic drugs. postoperative management Postoperative pain control is obtained with opioid sparing strategies, in order to avoid Post Operative Ileus (POI) and PONV. It is proposed to chew gum three times daily , fluid therapy, early mobilization, early feeding within 2 hours postoperative for at least 15 minutes and eventually to promote a faster bowel function.<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 | Measurement of pain score post-operation will be obtained using clinical data gathered by the care team providing routine clinical care, and asking routine pain score questions. The scale used is the standard 1-10 pain scale, with 1 being no pain or very mild discomfort, and 10 being very severe pain. | At moment 24 hours after surgery | 
| Presence/Absence of nausea | Treatment for postoperative nausea | At moment 0, 3, 6, 12 and 24 hours after surgery | 
| Presence/Absence of vomiting | Treatment for postoperative vomiting | At moment 0, 3, 6, 12 and 24 hours after surgery | 
| Time to flatus | Hours elapsed to event | Up to 4 weeks after surgery | 
| Time to bowel movement | Hours elapsed to event | Up to 4 weeks after surgery | 
| Foley catheter removal | Time to Foley catheter removal postoperative | From 1 to 14days post 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 2 weeks after surgery | 
| Time to adjuvant treatment | Time participant receives adjuvant treatment, if needed (chemotherapy or radiation) | 60 days | 
| Readmission rates | Readmissions to the hospital | Up to 21 days post surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preoperative / intraoperative/ postoperative management