Prehabilitation Plus ERAS vs ERAS in Gynecological Surgery

Instituto Brasileiro de Controle do Cancer

Status: Withdrawn

Conditions: Gynecologic Surgical Procedures; Enhanced Recovery After Surgery

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04505111

08304219.8.0000.0072

Details and patient eligibility

About

Prospective, interventionist, controlled and randomized study to test the effectiveness of 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 the multidisciplinary team but blind to surgeons and anaesthesiologists. The aim is to test the effectiveness of a multimodal prehabilitation protocol in patients with diagnosed or suspicious gynaecological cancer, who will undergo gynaecological surgery.

The multidisciplinary prehabilitation program will be applied to the intervention group. For the group participating in the prehabilitation and for the control group, the protocol and specific recommendations for gynecological cancer defined by the Enhanced Recovery After Surgery (ERAS®) guidelines will be applied.

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 locomotion 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;
• Non-adherence of the patient in the intervention group to the preoperative prehabilitation program.
• If surgery is performed 21 days after the last day of the prehabilitation program, for any reason

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 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