Effect of Probiotics in Patients Undergoing Surgery for Periampullary Neoplasms

Hospital de Clinicas de Porto Alegre

Status and phase: Completed; Phase 3

Conditions: Periampullary Carcinoma Nos

Treatments: Dietary Supplement: Sugar pill; Dietary Supplement: Probiotics

Study type: Interventional

Funder types: Other

Identifiers

NCT01468779

HCPA09256 (Other Identifier)

09256

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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58 participants in 2 patient groups, including a placebo group

Sugar pill

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Sugar pill

Probiotics

Active Comparator group

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.

Treatment:

Dietary Supplement: Probiotics