Urological ManifestationsIMPACTURONCT05520151
Influence of Preoperative Immunomodulation by Oral Impact on Postoperative Complications Following Cystectomies & Nephrectomies
A study testing ORAL IMPACT treatment in people with Urological Manifestations, run by Centre Hospitalier Intercommunal Robert Ballanger at 2 sites in France.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urological Manifestations
- What is being tested?
- ORAL IMPACT treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 2 sitesFrance
- Study dates
- 30 Nov 2022to Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
CHI Robert Ballanger
Aulnay-sous-Bois, 93600
Serge NDOKO, MD, 01 49 36 71 23, serge.ndoko@ght-gpne.fr
- Recruiting
CHI André Grégoire
Montreuil, 93100
Matthieu CAMBY, MD, 0149203040, matthieu.camby@ght-gpne.fr
About this study
Official title: Influence of Preoperative Immunomodulation by Oral Impact® on Postoperative Complications Following Cystectomies and Nephrectomies
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.
- Conditions
- Urological Manifestations
- Being tested
- ORAL IMPACT treatment, control
- Keywords
- cystectomy,, nephrectomy,, laparotomies, reduction of postoperative complications
- Medical subject headings
- Urological Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORAL IMPACT treatmentDietary supplement
Also called 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
the group of patients will be received a 7-days course of ORAL IMPACT
controlOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| ORAL impact group | Experimental | This group of patients will receive a 7-days course of IMPACT ORAL 20 days before the surgery Receives: Dietary Supplement: ORAL IMPACT treatment |
| control | Other | a retrospective cohort of patients operated between 2016 and 2019 by nephrectomy cystectomy and laparotomy who did not receive oral impact Receives: Other: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of major postoperative complications
the number of postoperative complications during this study for each patient
Measured: 3 months
Secondary outcomes (6)
Length of stay in hospital (LOS).
Length of stay in hospital (LOS). durind the participation of each patient
Measured: 3 months
Number of admissions in intensive care setting for severe complications.
Number of admissions in intensive care setting for severe complications after major urological surgery.
Measured: 3 months
Rate of transfusions of red blood cells.
Rate of transfusions of red blood cellsduring hospitalisation and after major urological surgery.
Measured: 3 months
mortality rate
3-month mortality rate
Measured: 3 months
Incidence of postoperative hypoalbuminemia
albumin analysis
Measured: 10 days post-surgery
the average rate of postoperative hypoalbuminemia
albumin analysis
Measured: 10 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start30 Nov 2022
- Primary completionJan 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Urological ManifestationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Multicentric, prospective non-randomized clinical study comparing the group of patients who received a 7-days course of ORAL IMAPCT to a retrospective cohort of patients operated between 2016 and 2019: cystectomy and nephrectomy by laparotomy.
- Masking
- None (open label)
- Enrolment
- 214 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Robert Ballanger
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Serge NDOKO, MD, Principal investigator, Robert ballangerMAtthieu CAMBY, MD, Principal investigator, Centre Hospitalier Intercommunal André Grégoire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05520151
- Sponsor's protocol ID
- GHT-CHIRB -20220411
- Acronym
- IMPACTURO
- Status last verified
- Jul 2024
- First submitted
- 25 Aug 2022
- Last updated
- 15 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 24009246Katona 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 18419494Argiles JM. Cancer-associated malnutrition. Eur J Oncol Nurs. 2005;9 Suppl 2:S39-50. doi: 10.1016/j.ejon.2005.09.006.
PubMed 16437757Barker 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
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Preoperative Immunomodulation by Oral Impact® on Postoperative Complications Following Cystectomies and Nephrectomies
- ClinicalTrials.gov ID
- NCT05520151
- Acronym / sponsor ID
- IMPACTURO / GHT-CHIRB -20220411
- Conditions
- Urological Manifestations
- Keywords
- cystectomy,, nephrectomy,, laparotomies, reduction of postoperative complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- Centre Hospitalier Intercommunal Robert BallangerUniversity, hospital or other
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 29 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicentric, prospective non-randomized clinical study comparing the group of patients who received a 7-days course of ORAL IMAPCT to a retrospective cohort of patients operated between 2016 and 2019: cystectomy and nephrectomy by laparotomy.
| Arm | Type | Receives |
|---|---|---|
| ORAL impact group | Experimental | Dietary Supplement: ORAL IMPACT treatmentThis group of patients will receive a 7-days course of IMPACT ORAL 20 days before the surgery |
| control | Other | Other: controla retrospective cohort of patients operated between 2016 and 2019 by nephrectomy cystectomy and laparotomy who did not receive oral impact |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- Immune deficiency.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ORAL IMPACT treatmentAlso: 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 complicationsthe group of patients will be received a 7-days course of ORAL IMPACT | Dietary supplement | ORAL impact group |
| controlno intervention | Other | control |
Primary outcome
Rate of major postoperative complications
Time frame: 3 months
the number of postoperative complications during this study for each patient
6 secondary outcomes
Length of stay in hospital (LOS).
Time frame: 3 months
Number of admissions in intensive care setting for severe complications.
Time frame: 3 months
Rate of transfusions of red blood cells.
Time frame: 3 months
mortality rate
Time frame: 3 months
Incidence of postoperative hypoalbuminemia
Time frame: 10 days post-surgery
the average rate of postoperative hypoalbuminemia
Time frame: 10 days post-surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
- Results publication: PubMed 24009246Finnerty 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.
- Results publication: PubMed 18419494Katona P, Katona-Apte J. The interaction between nutrition and infection. Clin Infect Dis. 2008 May 15;46(10):1582-8. doi: 10.1086/587658.
- Results publication: PubMed 16437757Argiles JM. Cancer-associated malnutrition. Eur J Oncol Nurs. 2005;9 Suppl 2:S39-50. doi: 10.1016/j.ejon.2005.09.006.
- Results publication: PubMed 21556200Barker 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Serge NDOKO, MD principal investigator
Robert ballanger
MAtthieu CAMBY, MD principal investigator
Centre Hospitalier Intercommunal André Grégoire
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ORAL IMPACT treatment in people with Urological Manifestations, run by Centre Hospitalier Intercommunal Robert Ballanger at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Serge Ndoko, MD (01.49.36.70.41 ext. +33, serge.ndoko@ght-gpne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of major postoperative complications (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05520151, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2024.