Perioperative administration of probiotics-colorectal cancer-operated by laparoscopy.
- Conditions
- Patients with Colorectal cancer (CCR) operated by laparoscopy
- Registration Number
- RPCEC00000116
- Lead Sponsor
- ational Center for Minimal Access Surgery
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 166
• 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.
• 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method • 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 Measures
Name Time Method • 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