Patients with Colorectal cancer (CCR) operated by laparoscopy
Conditions
Interventions
Group I (experimental): PROBIOTIKOS nº 2 (Brand Name), composed of a mixture of Lactobacillus rhamnosus (2 x 109 CFU/caps), Bifidobacterium breve (2 x 109 CFU/caps) and Lactobacillus casei (1x109 CFU/
Sponsors
National Center for Minimal Access Surgery
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Patients with 18 years or older. • The diagnosis of colorectal cancer is confirmed by biopsy and histological test. • The preoperative disease stage is estimated as I, II or III, according to TNM classification. •The proposed surgical procedure is a laparoscopic radical resection.
Exclusion criteria
Exclusion criteria: • Pregnancy. • Preoperative evidence of far-away metastasis (disease stage IV, according to TNM classification) • Known lactose intolerance. • Clinically significant immunodeficiency. • Additional gastrointestinal disorders (e.g. Crohn’s disease or ulcerative colitis). • Patients received antibiotics for the last 10 days before surgery. • Patients undergone urgent operation (e.g. intestinal obstruction or bleeding). • Bowel preparation for colonoscopy within 6 days prior to surgery. • Patients refuse participate in the trial. • Patients undergone abdominoperineal resection of the rectum.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Postoperative diarrhea incidence, measuring time: day +8 and day +30 • Postoperative infectious complications incidence, measuring time: day +8 and day +30 • Quality of Live (FACT-C questionnaire), measuring time: day -4; day +8 and day +30 | — |
Secondary
| Measure | Time frame |
|---|---|
| • Faecal microflora analysis, measuring time: day -4; day 0 (surgery) and day +8 • Location of the cancer, measuring time: day 0 (surgery) • Type of operation, measuring time: day 0 (surgery) • Total length of the intestinal resection, measuring time: day 0 (surgery) • Operative time, measuring time: day 0 (surgery) • Intra-operative bleeding, measuring time: day 0 (surgery) • Intra-abdominal drainage time (days), measuring time: day +2 to day +5, during hospital stay • Urinary catheter time (days), measuring time: day +2 to day +5, during hospital stay • Cumulative duration of antibiotic therapy, measuring time: day +2 to day +7, during hospital stay • First intestinal movement time (days), measuring time: day +2 to day +3 • Intake time of diet (days), measuring time: day +2 to day +3 • Post-operative hospital stay, measuring time: day +2 to day +8 | — |
Countries
Cuba
Contacts
Public ContactRafael Torres Peña
Centro Nacional de Cirugía de Mínimo Acceso
Outcome results
None listed