Prehabilitation Plus ERAS vs ERAS in Gynecological Surgery

Not Applicable

Withdrawn

• Conditions: Enhanced Recovery After Surgery; Gynecologic Surgical Procedures
• Interventions: Other: Prehabilitation Program + Enhanced Recovery After Surgery; Other: Enhanced Recovery After Surgery

• Registration Number: NCT04505111
• Lead Sponsor: Instituto Brasileiro de Controle do Cancer

Brief Summary

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

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 Timeline

• Study Start: 2020-07-23
• Study First Submitted: 2020-07-30
• Study First Submitted QC: 2020-08-05
• Study First Posted: 2020-08-10
• Primary Completion: 2020-10-01
• Study Completion: 2020-10-01
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-02
• Last Update Posted: 2022-04-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prehabilitation + Enhanced Recovery After Surgery	Prehabilitation Program + 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.
Enhanced Recovery After Surgery	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®.

Primary Outcome Measures

Name	Time	Method
Postoperative recovery time	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

Secondary Outcome Measures

Name	Time	Method
Health-related Quality of Life	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)
Change in muscle strength	Baseline and postoperatively at 30 and 60 days	Muscle strength is measured by using an dynamometer
Complications	Up to 30 postoperative days	Clavien-Dindo Classification, Grades I-V
Change in body mass	Baseline and postoperatively at 30 and 60 days	Body mass is measured by using a bioelectrical impedance analysis
Readmissions	Up to 30 postoperative days	Readmission to the Hospital Facilities
Changes in anxiety and depression from baseline	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.
Changes in functional capacity from baseline	Baseline and postoperatively at 30 and 60 days	Patients will perform a 6-Minute Walk Test
Compliance to the ERAS® program guidelines	Through study completion, an average of 1 year	Compliance to ERAS® protocol and implementation of the program
Intensive Care Unit admission rates	Up to 30 postoperative days	Postoperative Intensive Care Unit admission and stay
Hospital stay	Up to 30 days	Days from surgical procedure to hospital discharge

Trial Locations

Locations (1)

IBCC - Instituto Brasileiro de Controle do Cancer; 🇧🇷 São Paulo, Sao Paulo, Brazil