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

Instituto Brasileiro de Controle do Cancer

Status and phase: Enrolling; Phase 3

Conditions: Gynecologic Cancer; Enhanced Recovery After Surgery

Treatments: Other: Enhanced Recovery After Surgery; Other: Prehabilitation Program + Enhanced Recovery After Surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT04596800

36924620.7.0000.0072

Details and patient eligibility

About

Prospective, interventionist, controlled and randomized study to test the effectiveness of a multimodal prehabilitation protocol in patients who will undergo gynecological surgery.

Full 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.

Enrollment: 194 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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194 participants in 2 patient groups

Prehabilitation + Enhanced Recovery After Surgery

Experimental group

Description:

Patients allocated to the intervention group will undergo prehabilitation protocol (nutrition + exercise + psychological counselling), with individualized monitoring by the multidisciplinary team.

Treatment:

Other: Prehabilitation Program + Enhanced Recovery After Surgery

Enhanced Recovery After Surgery

Active Comparator group

Description:

Patients allocated to the control group will not undergo any pre-surgical intervention, except for preoperative counselling, already implicated in ERAS®.

Treatment:

Other: Enhanced Recovery After Surgery