Enhanced Recovery After Surgery, Gynecologic Cancer
Conditions
Keywords
Prehabilitation, Gynecologic Cancer, ERAS - Enhanced Recovery After Surgery, Gynecologic Surgery
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.
Interventions
Prehabilitation Program (nutrition + exercise + psychological counseling) + ERAS protocol
OTHEREnhanced Recovery After Surgery
ERAS
Sponsors
Instituto Brasileiro de Controle do Cancer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Masking description
Single-Blind (surgeons and anesthesiologists)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Readmissions | Up to 30 postoperative days | Readmission to the Hospital Facilities |
| Intensive Care Unit admission rates | Up to 30 postoperative days | Postoperative Intensive Care Unit admission and stay |
| 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) |
| 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. |
| 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 |
| 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 |
| 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 |
Countries
Brazil
Contacts
Primary ContactAndre Lopes, MD
Backup ContactAlayne Yamada, PhD
Outcome results
None listed