Status:
RECRUITING
Influence of Preoperative Immunomodulation by Oral Impact on Postoperative Complications Following Cystectomies & Nephrectomies
Lead Sponsor:
Centre Hospitalier Intercommunal Robert Ballanger
Conditions:
Urological Manifestations
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
any studies have shown the benefit of perioperative Oral Impact immunomodulation in gastrointestinal, ENT, gynecological and cardiac surgery. Studies in major Urological surgery are rare and not very ...
Detailed Description
Major surgery induces traumatic stress due to the surgical aggression which could lead to major postoperative complications and death when the patient organism is not ready or prepared to support this...
Eligibility 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.
Key Trial Info
Start Date :
November 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
214 Patients enrolled
Trial Details
Trial ID
NCT05520151
Start Date
November 30 2022
End Date
June 1 2025
Last Update
July 15 2024
Active Locations (2)
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1
CHI Robert Ballanger
Aulnay-sous-Bois, France, 93600
2
CHI André Grégoire
Montreuil, France, 93100