Prehabilitation Plus ERAS vs ERAS in Gynecological Surgery

April 2, 2022 updated by: André Lopes, Instituto Brasileiro de Controle do Cancer

Prehabilitation Plus Enhanced Recovery After Surgery Versus Enhanced Recovery After Surgery in Gynecological Surgery

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Sao Paulo
      • São Paulo, Sao Paulo, Brazil, 03102-002
        • IBCC - Instituto Brasileiro de Controle do Câncer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prehabilitation + Enhanced Recovery After Surgery
Patients allocated to the intervention group will undergo prehabilitation protocol (nutrition + exercise + psychological counselling), with individualized monitoring by the multidisciplinary team.
Other: Prehabilitation Program + Enhanced Recovery After Surgery
Prehabilitation Program (nutrition + exercise + psychological counseling) + ERAS protocol
Other Names:
  • Prehabilitation + ERAS
Active Comparator: Enhanced Recovery After Surgery
Patients allocated to the control group will not undergo any pre-surgical intervention, except for preoperative counselling, already implicated in ERAS®.
Other: Enhanced Recovery After Surgery
ERAS protocol
Other Names:
  • ERAS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative recovery time
Time Frame: Up to 30 postoperative days
Postoperative day patient is ready for discharge, defined as the day the patient has the ability to walk alone, take care of herself, and ingest at least 75% of the daily caloric needs
Up to 30 postoperative days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: Up to 30 postoperative days
Clavien-Dindo Classification, Grades I-V
Up to 30 postoperative days
Readmissions
Time Frame: Up to 30 postoperative days
Readmission to the Hospital Facilities
Up to 30 postoperative days
Intensive Care Unit admission rates
Time Frame: Up to 30 postoperative days
Postoperative Intensive Care Unit admission and stay
Up to 30 postoperative days
Health-related Quality of Life
Time Frame: At Baseline, then at 30 and 60 days postoperatively
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
At Baseline, then at 30 and 60 days postoperatively
Compliance to the ERAS® program guidelines
Time Frame: Through study completion, an average of 1 year
Compliance to ERAS® protocol and implementation of the program
Through study completion, an average of 1 year
Changes in anxiety and depression from baseline
Time Frame: Baseline and postoperatively at 30 and 60 days
Changes in anxiety and depression will be examined using the Hospital Anxiety and Depression Scale. Scores for each sub scale (depression and anxiety) are summed-up and range from 0 to 21. Values from 0-7 indicate normal levels, 8-10 are border values and values from 11-21 are considered to be pathological.
Baseline and postoperatively at 30 and 60 days
Changes in functional capacity from baseline
Time Frame: Baseline and postoperatively at 30 and 60 days
Patients will perform a 6-Minute Walk Test
Baseline and postoperatively at 30 and 60 days
Change in muscle strength
Time Frame: Baseline and postoperatively at 30 and 60 days
Muscle strength is measured by using an dynamometer
Baseline and postoperatively at 30 and 60 days
Change in body mass
Time Frame: Baseline and postoperatively at 30 and 60 days
Body mass is measured by using a bioelectrical impedance analysis
Baseline and postoperatively at 30 and 60 days
Hospital stay
Time Frame: Up to 30 days
Days from surgical procedure to hospital discharge
Up to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Brasileiro de Controle do Cancer

Investigators

  • Principal Investigator: Andre Lopes, MD, doctor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 23, 2020

Primary Completion (Actual)

October 1, 2020

Study Completion (Actual)

October 1, 2020

Study Registration Dates

First Submitted

July 30, 2020

First Submitted That Met QC Criteria

August 5, 2020

First Posted (Actual)

August 10, 2020

Study Record Updates

Last Update Posted (Actual)

April 11, 2022

Last Update Submitted That Met QC Criteria

April 2, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 08304219.8.0000.0072

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

After publication of the results

IPD Sharing Time Frame

After study enrollment

IPD Sharing Access Criteria

Public

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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