The Role of Preoperative Immunonutrition on Morbidity and Immune Response After Cystectomy (INCyst Trial)

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire Vaudois

About this trial

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 criteria

Qualifiers

Patient undergoing open cystectomy (for all reasons)

Age ≥18 years

Ability and willingness to provide informed consent documented by signature

Disqualifiers

Contraindications to IN, e.g. known hypersensitivity or allergy to lactose, fish oil or soy lecithin

Severe diarrhoea requiring medical attention

Current treatment with any immunosuppressive drug

In standard practice, pregnant or lactating women are systematically rejected by the surgeon for this surgical procedure. Furthermore, during the pre-surgical anaesthesia consultation, the eligibility of each patient for anaesthesia will be assessed according to the usual criteria and recommendations of the anaesthesia service of the CHUV

Trial design

Treatments tested in this trial

  • Immunonutrition

Treatment groups

232 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Centre Hospitalier Universitaire Vaudois

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Collaborator

Hôpital Riviera-Chablais, Vaud-Valais

Collaborator

University Hospital, Geneva

Collaborator