Effect of Probiotics in Patients Undergoing Surgery for Periampullary Neoplasms

NCT ID: NCT01468779

Last Updated: 2017-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2012-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Periampullary Carcinoma Nos

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sugar pill

The patients submitted to periampullary cancer surgery will receive sugar pills in the preoperative and postoperative period.

Group Type PLACEBO_COMPARATOR

Sugar pill

Intervention Type DIETARY_SUPPLEMENT

Probiotics

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.

Group Type ACTIVE_COMPARATOR

Probiotics

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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Probiotics

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.

Intervention Type DIETARY_SUPPLEMENT

Sugar pill

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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FIPE - Fundo de Incentivo a Pesquisa do Hospital de Clínicas de Porto Alegre

UNKNOWN

Sponsor Role collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role collaborator

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

OTHER_GOV

Sponsor Role collaborator

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

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Heloisa Sommacal

nutritionist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

Related Links

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Other Identifiers

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HCPA09256

Identifier Type: OTHER

Identifier Source: secondary_id

09256

Identifier Type: -

Identifier Source: org_study_id

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