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Effect of Probiotics in Patients Undergoing Surgery for Periampullary Neoplasms

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ClinicalTrials.gov Identifier: NCT01468779
Recruitment Status : Completed
First Posted : November 9, 2011
Last Update Posted : March 3, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Periampullary Carcinoma Nos Dietary Supplement: Probiotics Dietary Supplement: Sugar pill Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of the Probiotics Use in Patients Undergoing Surgery for Periampullary Neoplasia - A Randomized Clinical Trial
Study Start Date : February 2010
Primary Completion Date : December 2011
Study Completion Date : April 2012
Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: Sugar pill
The patients submitted to periampullary cancer surgery will receive sugar pills in the preoperative and postoperative period.
Dietary Supplement: Sugar pill
Active Comparator: 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.
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.


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01468779


Locations
Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
FIPE - Fundo de Incentivo a Pesquisa do Hospital de Clínicas de Porto Alegre
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
More Information

Responsible Party: Heloisa Sommacal, nutritionist, Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT01468779     History of Changes
Other Study ID Numbers: 09256
HCPA09256 ( Other Identifier: 09-256 )
First Posted: November 9, 2011    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: March 2017

Keywords provided by Heloisa Sommacal, Hospital de Clinicas de Porto Alegre:
Periampullary cancer
Surgery
Dietary supplementation
Nutritional assessment

Additional relevant MeSH terms:
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms