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

Launched by INSTITUTO BRASILEIRO DE CONTROLE DO CANCER · Oct 18, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the impact of a special program called "prehabilitation" combined with a recovery plan known as Enhanced Recovery After Surgery (ERAS) for women undergoing gynecological surgery. The aim is to see if this prehabilitation program, which includes exercises and support leading up to the surgery, helps patients recover better compared to those who only follow the standard ERAS plan.

Women between the ages of 18 and 80 who are scheduled for traditional gynecological surgery (not minimally invasive) may be eligible to participate. To join the trial, patients need to be able to understand the study and commit to a prehabilitation program for 2 to 3 weeks before their surgery. Participants can expect to engage in a tailored exercise program and receive guidance to help improve their overall health and recovery experience. It’s important to note that certain medical conditions or types of surgeries may exclude some women from taking part in this study.

Gender

FEMALE

Eligibility criteria

• 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