Using Oral Impact to Reduce Postoperative Complications in Urological Surgery
Influence of Preoperative Immunomodulation by Oral Impact® on Postoperative Complications Following Cystectomies and Nephrectomies
This study is testing if a special nutritional drink can help patients have fewer problems after major urological surgeries like bladder or kidney removal.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 214 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Intercommunal Robert Ballanger Academic / other |
| Locations | 2 sites (Aulnay-sous-Bois and 1 other locations) |
| Trial ID | NCT05520151 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of preoperative immunomodulation using Oral Impact on patients undergoing major urological surgeries such as cystectomies and nephrectomies. The approach focuses on enhancing the immune response and reducing postoperative complications through nutritional supplementation. By providing immune-modulating nutrient-enriched products, the study aims to prepare patients' bodies to better handle the stress of surgery, potentially leading to shorter hospital stays and fewer complications. The study will compare outcomes between patients receiving Oral Impact and those in a control group.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older scheduled for major urological surgeries who can provide informed consent.
Not a fit: Patients with immune deficiencies, urgent surgical needs, or those unable to take Oral Impact prior to surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce postoperative complications and hospital stays for patients undergoing major urological surgeries.
How similar studies have performed: Previous studies in other surgical fields have shown that similar immunomodulatory approaches can reduce complications, although research in urological surgery is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years of age and older * Scheduled major urological surgery: scheduled: cystectomy, nephrectomy, other laparotomies. * Having expressed their free and informed consent. * Affiliated to a social security scheme Exclusion Criteria: * Immune deficiency. * HIV infection. * Curative surgery for chronic urinary tract infection. * Urgent surgery. * Inability to take oral impact 7 days before surgery. * Unstable psychiatric state. * Infection with COVID 19 during postoperative stay.
Where this trial is running
Aulnay-sous-Bois and 1 other locations
- CHI Robert Ballanger — Aulnay-sous-Bois, France (Recruiting)
- CHI André Grégoire — Montreuil, France (Recruiting)
Study contacts
- Principal investigator: Serge NDOKO, MD — Robert ballanger
- Study coordinator: Serge Ndoko, MD
- Email: serge.ndoko@ght-gpne.fr
- Phone: 01.49.36.70.41
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.