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RecruitingNCT05520151IMPACTUROUpdated Jul 15, 2024

Influence of Preoperative Immunomodulation by Oral Impact on Postoperative Complications Following Cystectomies & Nephrectomies

An interventional study of ORAL IMPACT treatment and control in Urological Manifestations, sponsored by Centre Hospitalier Intercommunal Robert Ballanger. Recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-15.

Sponsored by Centre Hospitalier Intercommunal Robert Ballanger · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Jan 2025, 1 year 9 months ago, but the record still lists the study as recruiting.
  • Started Nov 2022; still recruiting 3 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
214
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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 contributory. The expected benefit is a reduction in postoperative complications and the average length of stay.

Read the 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 intense 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 improving 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 benefits have 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 nutritional status had been omitted from our preoperative anesthesia assessment and no 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 generates major metabolic stress that the human body must manage. 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 they are insufficiently prepared. Preoperative undernutrition is one of the risk factors for major postoperative complications.

Moreover, postoperative infection can occur despite the Oral Impact treatment and associated iron and protein-caloric rehabilitation. It is linked to postoperative hypoalbuminemia. The antimicrobial role of albumin in the body is significant due to its antioxidant power. Reduced, non-oxidized albumin is the primary antioxidant in the body. Postoperative inflammation consumes reduced albumin, thereby diminishing the body's antioxidant capacity and exposing it to complications and nosocomial infections. The exogenous supply of reduced albumin is therefore indispensable. The liver's albumin synthesis yield is too low in this inflammatory context, amounting to approximately one vial of 20% albumin per day. Preoperatively, the correction of any hypoalbuminemia is anticipated through the nutritional rehabilitation implemented with the dietitian team. The timing of the surgery does not always allow the body to correct this hypoalbuminemia on its own. It is also essential to correct it postoperatively, in case of complications if necessary, through the exogenous supply of 20% reduced albumin.

Numerous studies have shown the benefit of perioperative Oral Impact immunomodulation in gastrointestinal surgery, ear, nose and throat surgery, 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 the preoperative period of urological 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 patients undergoing urological surgery. There are no current guidelines recommending or discouraging the prescription of ORAL IMPACT in urological surgery patients.

02

Conditions studied

  • Urological Manifestations

Keywords

  • cystectomy,
  • nephrectomy,
  • laparotomies
  • reduction of postoperative complications
03

In context

Postoperative Complications

1,233 studies on the registry are indexed under Postoperative Complications; 292 are open to participants now.

This study's planned enrollment of 214 is above the median of 119 across 689 interventional studies indexed under Postoperative Complications.

Browse Postoperative Complications studies →

Lead sponsor

Centre Hospitalier Intercommunal Robert Ballanger is the lead sponsor of 6 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
214 participants (estimated)

Study arms

  • Experimental
    ORAL impact group

    This group of patients will receive a 7-days course of IMPACT ORAL 20 days before the surgery

    Dietary Supplement: ORAL IMPACT treatment

  • Other
    control

    a retrospective cohort of patients operated between 2016 and 2019 by nephrectomy cystectomy and laparotomy who did not receive oral impact

    Other: control

Interventions

  • Dietary supplementORAL IMPACT treatment

    the group of patients will be received a 7-days course of ORAL IMPACT

    Also known as: Monitoring of postoperative albumin on days 1, 3, 5, 7, and 10, correction of postoperative hypoalbuminemia (<35 g/L) by albumine 20% administration in case of postoperative complications

  • Othercontrol

    no intervention

06

What researchers measure

Primary outcomes

  1. Rate of major postoperative complications

    the number of postoperative complications during this study for each patient

    Time frame: 3 months

Secondary outcomes

  1. Length of stay in hospital (LOS).

    Length of stay in hospital (LOS). durind the participation of each patient

    Time frame: 3 months

  2. Number of admissions in intensive care setting for severe complications.

    Number of admissions in intensive care setting for severe complications after major urological surgery.

    Time frame: 3 months

  3. Rate of transfusions of red blood cells.

    Rate of transfusions of red blood cellsduring hospitalisation and after major urological surgery.

    Time frame: 3 months

  4. mortality rate

    3-month mortality rate

    Time frame: 3 months

  5. Incidence of postoperative hypoalbuminemia

    albumin analysis

    Time frame: 10 days post-surgery

  6. the average rate of postoperative hypoalbuminemia

    albumin analysis

    Time frame: 10 days post-surgery

07

Study locations

2 of 2 sites recruiting
  • CHI Robert Ballanger
    Aulnay-sous-Bois, 93600, France
    Recruiting
  • CHI André Grégoire
    Montreuil, 93100, France
    Recruiting
08

References and documents

Publications

  • 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. PubMed 24009246 ↗
  • 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. PubMed 18419494 ↗
  • Argiles JM. Cancer-associated malnutrition. Eur J Oncol Nurs. 2005;9 Suppl 2:S39-50. doi: 10.1016/j.ejon.2005.09.006. PubMed 16437757 ↗
  • 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. PubMed 21556200 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05520151
Lead sponsor
Centre Hospitalier Intercommunal Robert Ballanger
Responsible party
Sponsor
First posted
Aug 29, 2022
Start date
Nov 30, 2022
Primary completion
Jan 2025 (estimated)
Completion
Jun 2025 (estimated)
Last update
Jul 15, 2024

Study contacts

Serge Ndoko, MD
Contact
serge.ndoko@ght-gpne.fr
01.49.36.70.41 ext. +33
Sabrina Lassouani, MD
Contact
sabrina.lassouani-amara@ght-gpne.fr
01.49.36.70.41 ext. +33
Serge NDOKO, MD
principal investigator · Robert ballanger
MAtthieu CAMBY, MD
principal investigator · Centre Hospitalier Intercommunal André Grégoire

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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