Prehabilitation Plus ERAS Versus ERAS in Gynecologic Oncology: a Randomized Clinical Trial

Study Overview
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Brief Summary
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Prospective, interventionist, controlled and randomized study to test the effectiveness of a multimodal prehabilitation protocol in patients who will undergo gynecological surgery.

Detailed Description
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Prospective, interventionist and randomized controlled trial in a 1: 1 ratio, open to multidisciplinary team and blind to surgeons and anaesthesiologists. The aim is test the effectiveness of a multimodal prehabilitation protocol in patients who will undergo gynecological surgery. The multidisciplinary prehabilitation program will be applied to the intervention group. For the group participating in the prehabilitation and for the control group, specific recommendations for gynecological cancer defined by the Enhanced Recovery After Surgery (ERAS®) guidelines will be applied.

Official Title
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Prehabilitation Plus Enhanced Recovery After Surgery Versus Enhanced Recovery After Surgery in Gynecologic Oncology: a Randomized Clinical Trial

Conditions
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Gynecologic Cancer, Enhanced Recovery After Surgery

Intervention / Treatment
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* Other: Prehabilitation Program + Enhanced Recovery After Surgery
* Other: Enhanced Recovery After Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who sign the Informed Consent Form, indicating that they understand the study procedures and their purpose; Women aged between 18 and 80 years old; Gynecological surgery performed by laparotomy; Patients with Eastern Cooperative Oncology Group Performance Status of at least 2 (ECOG ≤2); Preoperative schedule that allows prehabilitation intervention for 2 to 3 weeks Exclusion Criteria: Patients under 18 or older than 80 years old; ECOG ≥3; Significant comorbidities, such as: neurological or musculoskeletal disorder, heart disease and / or respiratory failure that prohibit physical exercise; Limitation of ambulation preventing the patient to perform physical exercises; Cognitive deterioration or patients with psychiatric disorder that prevents adherence to the program; Emergency or urgency surgeries; Surgeries by minimally invasive approach (laparoscopy or robotics); Vulvectomy or soft tissue surgery without abdominal approach; Minor gynaecological surgeries such as conizations; Surgeries performed together with other specialties, in which the gynecology team is not primarily responsible for postoperative care; If surgery is performed 21 days after the last day of the prehabilitation program, for any reason

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prehabilitation + Enhanced Recovery After Surgery<br>Patients allocated to the intervention group will undergo prehabilitation protocol (nutrition + exercise + psychological counselling), with individualized monitoring by the multidisciplinary team. | Other: Prehabilitation Program + Enhanced Recovery After Surgery<br>* Prehabilitation Program (nutrition + exercise + psychological counseling) + ERAS protocol<br>* Other names: Prehabilitation + ERAS;|
| Active Comparator: Enhanced Recovery After Surgery<br>Patients allocated to the control group will not undergo any pre-surgical intervention, except for preoperative counselling, already implicated in ERAS®. | Other: Enhanced Recovery After Surgery<br>* ERAS<br>* Other names: ERAS protocol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative recovery time | Postoperative day patient is ready for discharge, defined as the day the patient has the ability to walk alone, take care of herself, and ingest at least 75% of the daily caloric needs | Up to 30 postoperative days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications and Adverse Effects | Complications and Adverse Effects according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 2017 | Up to 30 postoperative days | 
| Readmissions | Readmission to the Hospital Facilities | Up to 30 postoperative days | 
| Intensive Care Unit admission rates | Postoperative Intensive Care Unit admission and stay | Up to 30 postoperative days | 
| Health-related Quality of Life | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | At Baseline, the week before surgery, then at postoperative days 7, 30 and 60 | 
| Compliance to the ERAS® program guideline | Compliance to ERAS® protocol and implementation of the program | Up to 30 postoperative days | 
| Changes in anxiety and depression from baseline | Changes in anxiety and depression will be examined using the Hospital Anxiety and Depression Scale. Scores for each sub scale (depression and anxiety) are summed-up and range from 0 to 21. Values from 0-7 indicate normal levels, 8-10 are border values and values from 11-21 are considered to be pathological. | At Baseline, the week before surgery, then at postoperative days 7, 30 and 60 | 
| Changes in functional capacity from baseline | Patients will perform a 6-Minute Walk Test | At Baseline, the week before surgery, then at postoperative days 30 and 60 | 
| Change in muscle strength | Muscle strength is measured by using an dynamometer | At Baseline, the week before surgery, then at postoperative days 30 and 60 | 
| Change in body mass | Body mass is measured by using a bioelectrical impedance analysis | At Baseline, the week before surgery, then at postoperative days 30 and 60 | 
| Hospital stay | Days from surgical procedure to hospital discharge | Up to 30 days | 
| Use of opioids in acute postoperative pain | Use and dosage of opioids in the postoperative period | Up to 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prehabilitation, Gynecologic Cancer, ERAS - Enhanced Recovery After Surgery, Gynecologic Surgery