Perioperative administration of probiotics-colorectal cancer-operated by laparoscopy.

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000116
• Date of registration: 19/05/2011
• Primary sponsor: National Center for Minimal Access Surgery
• Public title: Perioperative administration of probiotics-colorectal cancer-operated by laparoscopy.
• Scientific title: Perioperative administration of probiotics in colorectal cancer patients operated by laparoscopy: A randomized double-blind trial.
• Date of first enrolment: 17/06/2011
• Target sample size: 166
• Recruitment status: Active
• URL: http://registroclinico.sld.cu/trials/RPCEC00000116-En
• Study type: Interventional
• Study design: Randomization: Randomized Controlled Trial Blinding: Double Blind Placebo: Placebo Assignment: Parallel Purpose: Other

Countries of recruitment

Cuba

Contacts

• Name: Rafael Torres Peña
• Affiliation: Centro Nacional de Cirugía de Mínimo Acceso

• Name: Rafael Torres Peña
• Affiliation: Centro Nacional de Cirugía de Mínimo Acceso

Key inclusion & exclusion 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: • 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.

Age minimum: 18 years
Age maximum: N/A (Not limit)
Gender: Both

Health Condition(s) or Problem(s) studied

Patients with Colorectal cancer (CCR) operated by laparoscopy

Intervention(s)

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/caps). Group II (control): Placebo compound by Maltodextrin 330 mg/caps. All two groups will receive 1 capsule of treatments or placebo orally twice a day with food breakfast/dinner) for three consecutive days before surgery (from day -3 to day -1 included). The day of surgery (day 0) the dose is 2 capsules in the early morning, offer it with a little amount of water. Treatments or placebo will be resumed postoperatively twice a day with food (breakfast/dinner) on day +2 until day +7 for a total of 10 days of treatment (20 doses).

Primary Outcome(s)

• 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 Outcome(s)

• 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

Secondary ID(s)

CNCMA-EC004

Source(s) of Monetary Support

Cuban Ministry of Public Health (MINSAP) National Center for Minimal Access Surgery (Cuba) BDSC sprl (Business Development Services & Consulting) (Belgium)

Secondary Sponsor(s)

Not applicable