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Effect of Probiotics in Patients Undergoing Surgery for Periampullary Neoplasms

Primary Purpose

Periampullary Carcinoma Nos

Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Probiotics
Sugar pill
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Periampullary Carcinoma Nos focused on measuring Periampullary cancer, Surgery, Dietary supplementation, Nutritional assessment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital de Clínicas de Porto Alegre

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Sugar pill

Probiotics

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 3, 2011
Last Updated
March 1, 2017
Sponsor
Hospital de Clinicas de Porto Alegre
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.
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1. Study Identification

Unique Protocol Identification Number
NCT01468779
Brief Title
Effect of Probiotics in Patients Undergoing Surgery for Periampullary Neoplasms
Official Title
Effect of the Probiotics Use in Patients Undergoing Surgery for Periampullary Neoplasia - A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
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.

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periampullary Carcinoma Nos
Keywords
Periampullary cancer, Surgery, Dietary supplementation, Nutritional assessment

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sugar pill
Arm Type
Placebo Comparator
Arm Description
The patients submitted to periampullary cancer surgery will receive sugar pills in the preoperative and postoperative period.
Arm Title
Probiotics
Arm Type
Active Comparator
Arm Description
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
Intervention Name(s)
Probiotics
Intervention Description
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
Intervention Name(s)
Sugar pill
Primary Outcome Measure Information:
Title
Mortality
Description
Death will be considered as the primary outcome related to complications of surgical treatment in postoperative period
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 15 days
Secondary Outcome Measure Information:
Title
Postoperative infection rate
Description
To assess postoperative infection rate in patients submitted to periampullary cancer surgery using probiotics.
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 15 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90035-903
Country
Brazil

12. IPD Sharing Statement

Links:
URL
http://www.hcpa.ufrgs.br/content/view/1596/1117/
Description
Related Info

Learn more about this trial

Effect of Probiotics in Patients Undergoing Surgery for Periampullary Neoplasms

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