Overview

This trial is active, not recruiting.

Condition periampullary carcinoma nos
Treatments probiotics, sugar pill
Phase phase 3
Sponsor Hospital de Clinicas de Porto Alegre
Collaborator FIPE - Fundo de Incentivo a Pesquisa do Hospital de Clínicas de Porto Alegre
Start date February 2010
End date December 2011
Trial size 58 participants
Trial identifier NCT01468779, 09256, HCPA09256

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Placebo Comparator)
The patients submitted to periampullary cancer surgery will receive sugar pills in the preoperative and postoperative period.
sugar pill
(Active Comparator)
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.
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.

Primary Outcomes

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

Secondary Outcomes

Measure
Postoperative infection rate
time frame: participants will be followed for the duration of hospital stay, an expected average of 15 days

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Effect of the Probiotics Use in Patients Undergoing Surgery for Periampullary Neoplasia - A Randomized Clinical Trial
Trial information was received from ClinicalTrials.gov and was last updated in November 2011.
Information provided to ClinicalTrials.gov by Hospital de Clinicas de Porto Alegre.