Status:
WITHDRAWN
Prehabilitation Plus ERAS vs ERAS in Gynecological Surgery
Lead Sponsor:
Instituto Brasileiro de Controle do Cancer
Conditions:
Gynecologic Surgical Procedures
Enhanced Recovery After Surgery
Eligibility:
FEMALE
18-80 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04505111
Start Date
July 23 2020
End Date
October 1 2020
Last Update
April 11 2022
Active Locations (1)
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1
IBCC - Instituto Brasileiro de Controle do Cancer
São Paulo, São Paulo, Brazil, 03102-002