Effect of Probiotics in Patients Undergoing Surgery for Periampullary Neoplasms

Phase 3

Completed

• Conditions: Periampullary Carcinoma Nos
• Interventions: Dietary Supplement: Sugar pill; Dietary Supplement: Probiotics

• Registration Number: NCT01468779
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2011-08-03
• Study First Submitted QC: 2011-11-07
• Study First Posted: 2011-11-09
• Primary Completion: 2011-12
• Study Completion: 2012-04
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-01
• Last Update Posted: 2017-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sugar pill	Sugar pill	The patients submitted to periampullary cancer surgery will receive sugar pills in the preoperative and postoperative period.
Probiotics	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 Outcome Measures

Name	Time	Method
Mortality	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

Name	Time	Method
Postoperative infection rate	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.

Trial Locations

Locations (1)

Hospital de Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil