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OpenTrials
Completed

NCT Number: NCT01468779

Effect of Probiotics in Patients Undergoing Surgery for Periampullary Neoplasms

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.

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Key information

Conditions

Periampullary Carcinoma Nos

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotics

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.

Sugar Pill

Dietary Supplement

Primary outcomes

  1. Mortality

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 15 days

    Death will be considered as the primary outcome related to complications of surgical treatment in postoperative period

Secondary outcomes

  1. Postoperative infection rate

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 15 days

    To assess postoperative infection rate in patients submitted to periampullary cancer surgery using probiotics.

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Nov 9, 2011
Registry last updated
Mar 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.