Prospective, interventionist, controlled and randomized study to test the effectiveness of a multimodal prehabilitation protocol in patients who will undergo gynecological surgery.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
194
Prehabilitation Program (nutrition + exercise + psychological counseling) + ERAS protocol
ERAS
Instituto Brasileiro de Controle do Cancer - IBCC
São Paulo, Brazil
RECRUITINGPostoperative 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
Time frame: Up to 30 postoperative days
Complications and Adverse Effects
Complications and Adverse Effects according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 2017
Time frame: Up to 30 postoperative days
Readmissions
Readmission to the Hospital Facilities
Time frame: Up to 30 postoperative days
Intensive Care Unit admission rates
Postoperative Intensive Care Unit admission and stay
Time frame: 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)
Time frame: 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
Time frame: 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.
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Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At Baseline, the week before surgery, then at postoperative days 30 and 60
Hospital stay
Days from surgical procedure to hospital discharge
Time frame: Up to 30 days
Use of opioids in acute postoperative pain
Use and dosage of opioids in the postoperative period
Time frame: Up to 30 days