The Role of Preoperative Immunonutrition on Morbidity and Immune Response After Cystectomy - A Multicenter Randomized Controlled Trial (INCyst Trial)
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The goal of this clinical trial research study is to evaluate the impact of preoperative oral immunonutrition (IN) on post-operative complications in patients undergoing a cystectomy. As a secondary focus, this study will aim to develop a signature that would identify patients that would benefit the most from IN. This is a multicentric (Swiss: N=3), prospective, controlled, pragmatic, parallel-group comparative study with block randomization stratified by centers.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Patient undergoing open cystectomy (for all reasons)
• Age ≥18 years
• Ability and willingness to provide informed consent documented by signature
Locations
Other Locations
Switzerland
University Hospital of Bern
RECRUITING
Bern
University Hospital of Geneva
RECRUITING
Geneva
Centre Hospitalier Universitaire Vaudois, CHUV
RECRUITING
Lausanne
Hospital of Riviera-Chablais
RECRUITING
Rennaz
Contact Information
Primary
Ilaria Lucca, MD
ilaria.lucca@chuv.ch
+41213142980
Time Frame
Start Date: 2023-04-10
Estimated Completion Date: 2026-10
Participants
Target number of participants: 232
Treatments
Experimental: Immunonutrition
Seven days of preoperative oral supplementation with an immune-enhanced oral nutrition
No_intervention: No immunonutrition (control)
Standard of care
Related Therapeutic Areas
Sponsors
Collaborators: University Hospital, Geneva, Insel Gruppe AG, University Hospital Bern, Hôpital Riviera-Chablais, Vaud-Valais
Leads: Centre Hospitalier Universitaire Vaudois