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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Intercommunal Robert Ballanger

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Immune deficiency.

HIV infection.

Curative surgery for chronic urinary tract infection.

Urgent surgery.

Trial design

Design model

Single group

Treatments tested in this trial

  • ORAL IMPACT treatment

    Dietary supplement

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

  • control

    Other intervention

    no intervention

Treatment groups

214 Participants
are divided into 2 treatment groups
Group A: ORAL impact groupExperimental treatment 1 intervention
Group B: controlOther 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

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