Prehabilitation Plus Enhanced Recovery After Surgery Versus Enhanced Recovery After Surgery in Gynecological Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Locations
- 2
- Primary Endpoint
- Postoperative recovery time
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Masking Description
Single-Blind (surgeons and anesthesiologists)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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;
- •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
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Change in muscle strength(Baseline and postoperatively at 30 and 60 days)
- Health-related Quality of Life(At Baseline, then at 30 and 60 days postoperatively)
- Complications(Up to 30 postoperative days)
- Change in body mass(Baseline and postoperatively at 30 and 60 days)
- Readmissions(Up to 30 postoperative days)
- Changes in anxiety and depression from baseline(Baseline and postoperatively at 30 and 60 days)
- Changes in functional capacity from baseline(Baseline and postoperatively at 30 and 60 days)
- Compliance to the ERAS® program guidelines(Through study completion, an average of 1 year)
- Intensive Care Unit admission rates(Up to 30 postoperative days)
- Hospital stay(Up to 30 days)
Investigators
André Lopes
MD
Instituto Brasileiro de Controle do Cancer