Image

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

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

Recruiting
18-80 years
Female
Phase 3

Powered by AI

Overview

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

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.

Eligibility

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

Study details
    Gynecologic Cancer
    Enhanced Recovery After Surgery

NCT04596800

Instituto Brasileiro de Controle do Cancer

27 January 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.