NCT05520151

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

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
214

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2022

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 29, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

November 30, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

July 15, 2024

Status Verified

July 1, 2024

Enrollment Period

2.1 years

First QC Date

August 25, 2022

Last Update Submit

July 11, 2024

Conditions

Urological Manifestations

Keywords

cystectomy,nephrectomy,laparotomiesreduction of postoperative complications

Outcome Measures

Primary Outcomes (1)

  • Rate of major postoperative complications

    the number of postoperative complications during this study for each patient

    3 months

Secondary Outcomes (6)

  • Length of stay in hospital (LOS).

    3 months

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

    3 months

  • Rate of transfusions of red blood cells.

    3 months

  • mortality rate

    3 months

  • Incidence of postoperative hypoalbuminemia

    10 days post-surgery

  • +1 more secondary outcomes

Study Arms (2)

ORAL impact group

EXPERIMENTAL

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

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

Other: control

Interventions

ORAL IMPACT treatmentDIETARY_SUPPLEMENT

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
ORAL impact group
controlOTHER

no intervention

control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHI Robert Ballanger

Aulnay-sous-Bois, 93600, France

RECRUITING

CHI André Grégoire

Montreuil, 93100, France

RECRUITING

Related Publications (4)

  • 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.

    PMID: 24009246RESULT

  • 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.

    PMID: 18419494RESULT

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

    PMID: 16437757RESULT

  • 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.

    PMID: 21556200RESULT

MeSH Terms

Conditions

Urological Manifestations

Interventions

Organization and Administration

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Services Administration

Study Officials

  • Serge NDOKO, MD

    Robert ballanger

    PRINCIPAL INVESTIGATOR

  • MAtthieu CAMBY, MD

    Centre Hospitalier Intercommunal André Grégoire

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Serge Ndoko, MD

CONTACT

01.49.36.70.41serge.ndoko@ght-gpne.fr

Sabrina Lassouani, MD

CONTACT

01.49.36.70.41sabrina.lassouani-amara@ght-gpne.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2022

First Posted

August 29, 2022

Study Start

November 30, 2022

Primary Completion

January 1, 2025

Study Completion

June 1, 2025

Last Updated

July 15, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)