Prehabilitation Plus ERAS Versus ERAS in Gynecologic Oncology: a Randomized Clinical Trial
- Conditions
- Gynecologic CancerEnhanced Recovery After Surgery
- Interventions
- Other: Enhanced Recovery After SurgeryOther: Prehabilitation Program + Enhanced Recovery After Surgery
- Registration Number
- NCT04596800
- Lead Sponsor
- Instituto Brasileiro de Controle do Cancer
- Brief Summary
Prospective, interventionist, controlled and randomized study to test the effectiveness of a multimodal prehabilitation protocol in patients who will undergo gynecological surgery.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 194
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Enhanced Recovery After Surgery Enhanced Recovery After Surgery Patients allocated to the control group will not undergo any pre-surgical intervention, except for preoperative counselling, already implicated in ERAS®. Prehabilitation + Enhanced Recovery After Surgery Prehabilitation Program + Enhanced Recovery After Surgery Patients allocated to the intervention group will undergo prehabilitation protocol (nutrition + exercise + psychological counselling), with individualized monitoring by the multidisciplinary team.
- Primary Outcome Measures
Name Time Method Postoperative recovery time Up to 30 postoperative days 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
- Secondary Outcome Measures
Name Time Method Complications and Adverse Effects Up to 30 postoperative days Complications and Adverse Effects according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 2017
Readmissions Up to 30 postoperative days Readmission to the Hospital Facilities
Health-related Quality of Life At Baseline, the week before surgery, then at postoperative days 7, 30 and 60 European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Intensive Care Unit admission rates Up to 30 postoperative days Postoperative Intensive Care Unit admission and stay
Compliance to the ERAS® program guideline Up to 30 postoperative days Compliance to ERAS® protocol and implementation of the program
Changes in anxiety and depression from baseline At Baseline, the week before surgery, then at postoperative days 7, 30 and 60 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.
Changes in functional capacity from baseline At Baseline, the week before surgery, then at postoperative days 30 and 60 Patients will perform a 6-Minute Walk Test
Change in muscle strength At Baseline, the week before surgery, then at postoperative days 30 and 60 Muscle strength is measured by using an dynamometer
Change in body mass At Baseline, the week before surgery, then at postoperative days 30 and 60 Body mass is measured by using a bioelectrical impedance analysis
Hospital stay Up to 30 days Days from surgical procedure to hospital discharge
Use of opioids in acute postoperative pain Up to 30 days Use and dosage of opioids in the postoperative period
Trial Locations
- Locations (1)
Instituto Brasileiro de Controle do Cancer - IBCC
🇧🇷Sao Paulo, Brazil