Effect of Probiotics in Patients Undergoing Surgery for Periampullary Neoplasms
This study is ongoing, but not recruiting participants.
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.
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
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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
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 May 21, 2013