Prehabilitation Plus ERAS vs ERAS in Gynecological Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-23

Study Completion Date

2020-10-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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Gynecologic Surgical Procedures Enhanced Recovery After Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Single-Blind (surgeons and anesthesiologists)

Study Groups

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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.

Group Type EXPERIMENTAL

Prehabilitation Program + Enhanced Recovery After Surgery

Intervention Type OTHER

Prehabilitation Program (nutrition + exercise + psychological counseling) + ERAS protocol

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®.

Group Type ACTIVE_COMPARATOR

Enhanced Recovery After Surgery

Intervention Type OTHER

ERAS protocol

Interventions

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Prehabilitation Program + Enhanced Recovery After Surgery

Prehabilitation Program (nutrition + exercise + psychological counseling) + ERAS protocol

Intervention Type OTHER

Enhanced Recovery After Surgery

ERAS protocol

Intervention Type OTHER

Other Intervention Names

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Prehabilitation + ERAS ERAS

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes