/A

Phase 1

Conditions: segmental colectomy surgery for colon cancer
MedDRA version: 20.0Level: PTClassification code 10009944Term: Colon cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Registration Number: EUCTR2017-002542-72-FR

Lead Sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 1112

Inclusion Criteria

patients aged 18 or more, scheduled to undergo elective restorative laparoscopic segmental colectomy for colon cancer, with signed consent, affiliated to the french social security system.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1112
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Emergent surgery, scheduled total or subtotal colectomy (defined as a colectomy extedent from the right colon to at least the left colonic angel) ; scheduled transverse colectomy, scheduled associated proctectomy, scheduled associated concomitant resection of another organ (liver, etc except the abdominal wall) ; previous segmental colectomy associated inflammatory bowel disease, active bacterial infection at the time of surgery or recent antimicrobial therapy (up to 2 weeks before surgery), patients with known colonization with multidrug - resistant enterobacteria ; history of allergy to the study drug (ornidazole, gentamycin,or contraindication to the ornidazole, gentamicin (antibiotic study), or to one of the drug exipient used
cirrhose B or C (Child -Pugh scale)
Myastheny ;
Patient with central or peripheric neurologic deseases ;
pregnant patients, and refusal to participate or inability to provide informed consent.