Prehabilitation program for women undergoing gynecologic surgery
Prehabilitation Plus Enhanced Recovery After Surgery Versus Enhanced Recovery After Surgery in Gynecologic Oncology: a Randomized Clinical Trial
This study tests if a special pre-surgery program can help women recover better after gynecologic surgery compared to just following standard recovery guidelines.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 194 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Female |
| Sponsor | Instituto Brasileiro de Controle do Cancer Academic / other |
| Locations | 1 site (Sao Paulo) |
| Trial ID | NCT04596800 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a multimodal prehabilitation protocol in women scheduled for gynecological surgery. Participants are randomly assigned to either receive the prehabilitation program alongside Enhanced Recovery After Surgery (ERAS) guidelines or to follow ERAS guidelines alone. The study aims to improve recovery outcomes by implementing a structured preoperative intervention over a period of 2 to 3 weeks. The trial is conducted in a controlled environment with a multidisciplinary team involved in the care of the patients.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 80 who are scheduled for laparotomy due to gynecological cancer and can participate in a prehabilitation program.
Not a fit: Patients with significant comorbidities, cognitive impairments, or those requiring emergency surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance recovery and improve surgical outcomes for women undergoing gynecologic surgery.
How similar studies have performed: Other studies have shown promising results with prehabilitation programs in surgical settings, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Sao Paulo
- Instituto Brasileiro de Controle do Cancer - IBCC — Sao Paulo, Brazil (Recruiting)
Study contacts
- Principal investigator: Andre Lopes, MD — Instituto Brasileiro de Controle do Cancer
- Study coordinator: Andre Lopes, MD
- Email: andrelopes.cirurgia@gmail.com
- Phone: +551134744242
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.