"Influence of Preoperative Immunomodulation by Oral Impact® on Postoperative Complications Following Cystectomies and Nephrectomies

Urological Manifestations Clinical Trial

— IMPACTURO  

Official title:

"Influence of Preoperative Immunomodulation by Oral Impact® on Postoperative Complications Following Cystectomies and Nephrectomies

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05520151
• Other study ID #: GHT-CHIRB -20220411
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: September 2022
• Est. completion date: June 2025

Study information

• Verified date: August 2022
• Source: Raincy Montfermeil Hospital Group
• Contact: Serge Ndoko, MD
• Phone: 01.49.36.70.41
• Email: serge.ndoko[@]ght-gpne.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

any studies have shown the benefit of perioperative Oral Impact immunomodulation in gastrointestinal, ENT, gynaecological and cardiac surgery . Studies in major Urological surgery are rare and are rare and not very contributory. The expected benefit is a reduction in postoperative complications and the average length of stay.

Description:

Major surgery induces a traumatic stress due to the surgical aggression that could lead to major postoperative complications and death when the patient organism is not ready or prepared to support this intense corporeal stress. Malnutrition can be caused by chronic starvation, chronic inflammatory disease and acute injury (stress, acute inflammation). Therefore, nutritional supplements are indicated for patients who do not meet their energy needs through oral food ingestion. Immune-modulating nutrient-enriched products containing arginine, Omega-3 polyunsaturated fatty acids (PUFAs), nucleic acids, vitamins and antioxidants (selenium) like ORAL IMPACT (Nestlé) can modulate immune and inflammatory processes in burn, trauma, major surgery and improve clinical outcomes. These immune-modulating nutrient-enriched products have shown their ability to decrease postoperative complications up to 50% in patients undergoing non-gastrointestinal major surgery and length of hospital and ICU stay (Jie B 2012, Drover 2011). Mortality benefit has been demonstrated in one study focused on Neck and Head surgery. (Buijs N, 2010) Before 2019, in our urology surgery setting, it seemed that the postoperative complications rate was clinically increasing despite reliable surgeons and excellent surgery techniques and procedures. It appeared that the sources of these complications might be the weakness of the patients against major surgical stress. Patients might have been malnourished. The nutrition status had been omitted from our preoperative anesthesia assessment and none perioperative nutritional rehabilitation had been performed.

The effect of immune-modulating nutrient-enriched products had been demonstrated mostly in gastrointestinal surgery but also in non-gastrointestinal surgeries such as neck and head cancer surgery, gynecologic cancer surgery and cardiac surgery. There are not studies conducted in urologic major surgery.

Reducing the number of post-operative complications is a major challenge in surgery because they cause an increase in the length of stay, which translates into higher hospital costs for the community. Surgery is an act that generates major metabolic stress that the human body must contain. This metabolic stress will manifest itself in an increase in catabolism and a decrease in anabolism, resulting in protein-energy malnutrition in the patient if this latter is insufficiently prepared. Preoperative undernutrition is one of the risk factors for major postoperative complications.

Numerous studies have shown the benefit of perioperative Oral Impact immunomodulation in gastrointestinal surgery, ear-nose and throat, gynecological and cardiac surgery.

No studies have been done in major Urological surgery The proposed study will be the first formal evaluation of the benefits and risks of using ORAL IMPACT in preoperative period of urology surgery. The choice of this clinical project for this research question is justified by the proven benefit of this food substitute perioperatively in gastrointestinal, ear-nose and throat, gynecological and cardiac surgery. We hypothesize that Oral Impact will protect against major postoperative complications and prolonged hospital stay for included patients undergoing urological surgery. There are no current guidelines recommending or discouraging the prescription of ORAL IMPACT in urological surgery patients.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 214
• Est. completion date: June 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Postoperative Complications
• Urological Manifestations

Intervention

Dietary Supplement:
• ORAL IMPACT treatment
the group of patients will be received a 7-days course of ORAL IMPACT

Other:
• control
no intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Raincy Montfermeil Hospital Group

References & Publications (4)

Argilés JM. Cancer-associated malnutrition. Eur J Oncol Nurs. 2005;9 Suppl 2:S39-50. Review. — View Citation

Barker LA, Gout BS, Crowe TC. Hospital malnutrition: prevalence, identification and impact on patients and the healthcare system. Int J Environ Res Public Health. 2011 Feb;8(2):514-27. doi: 10.3390/ijerph8020514. Epub 2011 Feb 16. Review. — View Citation

Finnerty CC, Mabvuure NT, Ali A, Kozar RA, Herndon DN. The surgically induced stress response. JPEN J Parenter Enteral Nutr. 2013 Sep;37(5 Suppl):21S-9S. doi: 10.1177/0148607113496117. — View Citation

Katona P, Katona-Apte J. The interaction between nutrition and infection. Clin Infect Dis. 2008 May 15;46(10):1582-8. doi: 10.1086/587658. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of major postoperative complications	the number of postoperative complications during this study for each patient	3 months
Secondary	Length of stay in hospital (LOS).	Length of stay in hospital (LOS). durind the participation of each patient	3 months
Secondary	Number of admissions in intensive care setting for severe complications.	Number of admissions in intensive care setting for severe complications after major urological surgery.	3 months
Secondary	Rate of transfusions of red blood cells.	Rate of transfusions of red blood cellsduring hospitalisation and after major urological surgery.	3 months
Secondary	mortality rate	3-month mortality rate	3 months