Effect of Probiotics in Patients Undergoing Surgery for Periampullary Neoplasms

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Hospital de Clinicas de Porto Alegre.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
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.
Information provided by (Responsible Party):
Heloisa Sommacal, Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT01468779
First received: August 3, 2011
Last updated: November 7, 2011
Last verified: November 2011
  Purpose

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 Intervention Phase
Periampullary Carcinoma Nos
Dietary Supplement: Probiotics
Dietary Supplement: Sugar pill
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of the Probiotics Use in Patients Undergoing Surgery for Periampullary Neoplasia - A Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:
  • Mortality [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 15 days ] [ Designated as safety issue: No ]
    Death will be considered as the primary outcome related to complications of surgical treatment in postoperative period


Secondary Outcome Measures:
  • Postoperative infection rate [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 15 days ] [ Designated as safety issue: No ]
    To assess postoperative infection rate in patients submitted to periampullary cancer surgery using probiotics.


Estimated Enrollment: 58
Study Start Date: February 2010
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
No publications provided

Responsible Party: Heloisa Sommacal, nutritionist, Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT01468779     History of Changes
Other Study ID Numbers: 09256, HCPA09256
Study First Received: August 3, 2011
Last Updated: November 7, 2011
Health Authority: Brazil: Ethics Committee

Keywords provided by 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

ClinicalTrials.gov processed this record on September 18, 2014