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

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General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Perioperative administration of probiotics in colorectal cancer patients operated by laparoscopy: A randomized double-blind trial.

Secondary indentifying numbers:

CNCMA-EC004

Issuing authority of the secondary identifying numbers:

National Center for Minimal Access Surgery

Source(s) of monetary or material support:

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

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Institute of Nutrition and Hygiene of food(INHA)

Authorization date :

04/05/2011

Reference number:

AI-279

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Rafael Torres Peña, MD, PhD

Last name:

Not entered

Affiliation:

Not entered

Postal address:

Not entered

City:

Not entered

País:

Not entered

Zip Code:

Not entered

Email address:

email@not.entered

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Not applicable

Research ethics committees:

Approved in 30 January 2011 by Ethic Committee of National Center for Minimal Access Surgery

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Recruiting

Date of first enrollment:

17/06/2011

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

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).

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

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

Key secondary outcomes:

• 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

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

N/A (Not limit)

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.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Other

Allocation:

Randomized controlled trial

Masking:

Double Blind

Control group:

Placebo

Study design:

Parallel

Phase:

2

Target sample size:

166

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Rafael

Last Name:

Torres Peña

Affiliation:

Centro Nacional de Cirugía de Mínimo Acceso

Postal Address:

Calle Párraga 215 entre Vista Alegre y San Mariano. 10 de Octubre.

City:

La Habana

País:

Cuba

Zip Code:

10700

Telephone:

(537) 649-5333 | FAX: (537) 649-0150

Email :

torres@cce.sld.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Rafael

Last Name:

Torres Peña

Affiliation:

Centro Nacional de Cirugía de Mínimo Acceso

Postal Address:

Calle Párraga 215 entre Vista Alegre y San Mariano. 10 de Octubre.

City:

La Habana

País:

Cuba

Zip Code:

10700

Telephone:

(537) 649-5333 | FAX: (537) 649-0150

Email :

torres@cce.sld.cu

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000116

Date of Registration in Primary Registry:

2011-05-19

Record Verification Date:

2011-05-06 20:00

Link to the spanish version:

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Ensayos Registrados

Proceso de Registro

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

Acerca del RPCEC

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