Clinical trial NCT04505111: Prehabilitation Plus ERAS vs ERAS in Gynecological Surgery
Official title: Prehabilitation Plus Enhanced Recovery After Surgery Versus Enhanced Recovery After Surgery in Gynecological Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Gynecologic Surgical Procedures
Enhanced Recovery After Surgery
Keywords: Prehabilitation
Gynecological Cancer
ERAS - Enhanced Recovery After Surgery
Gynecologic Surgery
Lead sponsor: Instituto Brasileiro de Controle do Cancer
Sponsor class: OTHER
First posted: 2020-08-10
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative recovery time
timeFrame: Up to 30 postoperative days
Secondary outcomes:
measure: Complications
timeFrame: Up to 30 postoperative days
measure: Readmissions
timeFrame: Up to 30 postoperative days
measure: Intensive Care Unit admission rates
timeFrame: Up to 30 postoperative days
measure: Health-related Quality of Life
timeFrame: At Baseline, then at 30 and 60 days postoperatively
measure: Compliance to the ERAS® program guidelines
timeFrame: Through study completion, an average of 1 year
measure: Changes in anxiety and depression from baseline
timeFrame: Baseline and postoperatively at 30 and 60 days
measure: Changes in functional capacity from baseline
timeFrame: Baseline and postoperatively at 30 and 60 days
measure: Change in muscle strength
timeFrame: Baseline and postoperatively at 30 and 60 days
measure: Change in body mass
timeFrame: Baseline and postoperatively at 30 and 60 days
measure: Hospital stay
timeFrame: Up to 30 days
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: IBCC - Instituto Brasileiro de Controle do Cancer
state: Sao Paulo
Study officials:
affiliation: Doctor
name: Andre Lopes, MD
role: PRINCIPAL_INVESTIGATOR
References:
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