segmental colectomy surgery for colon cancer MedDRA version: 20.0 Level: PT Classification code 10009944 Term: Colon cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: gentamicine panpharma
Product Name: gentamicine panpharma
Product Code: gentamicine
Pharmaceutical Form: Solution for injection
INN or Proposed INN: gentamicine
CAS Number: 140541-0
Concen
Sponsors
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: postoperative surgery 30-day site infection rate.;Secondary Objective: - 30-day postoperative overall morbidity - 30 -day postoperative severe morbidity (defined as a complication graded Clavien -Dindo 3 or more) - 30 -day postoperative mortality - 90-day postoperative anastomotic leakage rate - lenght of postoperative hospital day - 90 day postoperative unplanned hospitalization, -clostridium difficile colitis occurence - preoperative colonic preparation tolerance ;Primary end point(s): Principal evaluation criteria : postoperative surgery 30-day site infection rate. Secondary evaluation criteria : - 30-day postoperative overall morbidity - 30 -day postoperative severe morbidity (defined as a complication graded Clavien -Dindo 3 or more) - 30 -day postoperative mortality - 90-day postoperative anastomotic leakage rate - lenght of postoperative hospital day - 90 day postoperative unplanned hospitalization, -clostridium difficile colitis occurence - preoperative colonic preparation tolerance | — |
Countries
France
Contacts
Public ContactDRCI Hôpital St Louis
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Outcome results
None listed