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Effect of Probiotics in Patients Undergoing Surgery for Periampullary Neoplasms

Effect of the Probiotics Use in Patients Undergoing Surgery for Periampullary Neoplasia - A Randomized Clinical Trial

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01468779
Enrollment
58
Registered
2011-11-09
Start date
2010-02-28
Completion date
2012-04-30
Last updated
2017-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periampullary Carcinoma Nos

Keywords

Periampullary cancer, Surgery, Dietary supplementation, Nutritional assessment

Brief summary

The purpose of this study is to evaluate the effect of the probiotic use in patients with periampullary cancers undergone curative or palliative treatment considering nutritional status, postoperative complications, infection rate, length of hospitalization and mortality.

Interventions

DIETARY_SUPPLEMENTProbiotics

The probiotics pills are given orally in the amount of two pills twice a day as early as two days before surgery until ten days after surgery.

DIETARY_SUPPLEMENTSugar pill

Sponsors

FIPE - Fundo de Incentivo a Pesquisa do Hospital de Clínicas de Porto Alegre
CollaboratorUNKNOWN
Conselho Nacional de Desenvolvimento Científico e Tecnológico
CollaboratorOTHER_GOV
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
CollaboratorOTHER_GOV
Hospital de Clinicas de Porto Alegre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients in need of surgery for periampullary cancer

Exclusion criteria

* Patients submitted to periampullary surgery without pathologic confirmation of cancer * Patients unwilling to be a part of the trial

Design outcomes

Primary

MeasureTime frameDescription
Mortalityparticipants will be followed for the duration of hospital stay, an expected average of 15 daysDeath will be considered as the primary outcome related to complications of surgical treatment in postoperative period

Secondary

MeasureTime frameDescription
Postoperative infection rateparticipants will be followed for the duration of hospital stay, an expected average of 15 daysTo assess postoperative infection rate in patients submitted to periampullary cancer surgery using probiotics.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026