NCT04596800

Prehabilitation Plus ERAS Versus ERAS in Gynecologic Oncology: a Randomized Clinical Trial

Prehabilitation Plus Enhanced Recovery After Surgery Versus Enhanced Recovery After Surgery in Gynecologic Oncology: a Randomized Clinical Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 194 (estimated)
• Sponsor: Instituto Brasileiro de Controle do Cancer · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

Prospective, interventionist, controlled and randomized study to test the effectiveness of a 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 multidisciplinary team and blind to surgeons and anaesthesiologists. The aim is test the effectiveness of a multimodal prehabilitation protocol in patients who will undergo gynecological surgery. The multidisciplinary prehabilitation program will be applied to the intervention group. For the group participating in the prehabilitation and for the control group, specific recommendations for gynecological cancer defined by the Enhanced Recovery After Surgery (ERAS®) guidelines will be applied.

Conditions

• Gynecologic Cancer
• Enhanced Recovery After Surgery

Interventions

Type	Name	Description
OTHER	Prehabilitation Program + Enhanced Recovery After Surgery	Prehabilitation Program (nutrition + exercise + psychological counseling) + ERAS protocol
OTHER	Enhanced Recovery After Surgery	ERAS

Timeline

• Start date: 2020-11-05
• Primary completion: 2024-10-01
• Completion: 2024-12-01
• First posted: 2020-10-22
• Last updated: 2023-10-31

Locations

1 site across 1 country: Brazil