Post-operative infective complications and long term oncological outcome in patients undergoing surgery for colorectal cancer MedDRA version: 14.1 Level: LLT Classification code 10059428 Term: Postoperative infection System Organ Class: 100000004862 MedDRA version: 14.1 Level: PT Classification code 10061451 Term: Colorectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: SDD (selective decontamination of the digestive tract) suspension consists of 100 mg colistin sulphate, 80 mg of tobramycin and 500 mg of amphotericin B
Product Name: SDD
Product Code: SDD
Sponsors
VU medical center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Elective colon and rectal cancer surgery with primary anastomosis • No evidence of distant metastases (preoperative CT-abdomen and X-thorax or CT-thorax) • Procedure either with or without diverting stoma • Both laparoscopic and open surgery • Informed consent 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 762 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Previous colorectal surgery • Inflammatory bowel disease (Crohn’s disease or ulcerative colitis) • Other malignancy • Other malignancies in medical history • Surgery for diverticular disease • Performance status > ASA 3 (American Society for Anaesthesiologists) • Expected adverse reactions/allergies for study medication • Closure of temporary colostomy or ileostomy • Immunocompromised patients (prednisone) • Familial adenomatous polyposis coli (FAP; Lynch syndrome), Hereditary Non Polyposis Colorectal Cancer (HNPCC) • Preoperative evidence of metastases • Mental disorder/unable to give informed consent • Pregnancy
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The following secondary endpoints are formulated: • Disease free survival at 3 and 5 years • Other postoperative infectious complications including pneumonia, urinary tract infections, surgical site infections, wound dehiscence, (remote) intra-abdominal abscess • Non-infectious complications including cardiac failure, cerebrovascular events, deep venous thrombosis • In-hospital mortality • Readmission rate • Reoperation rate • Duration of hospital stay • Quality of life (quality adjusted life years) • In hospital and out-of-hospital costs ;Timepoint(s) of evaluation of this end point: 6 weeks, 3 years and 5 years, depending on end point | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives of this randomized clinical trial are to evaluate if perioperative SDD can reduce anastomotic leakage rate and other infectious complications while thereby simultaneously improving long-term oncological outcome. ;Secondary Objective: Secondary objectives are a decline in reoperation rate, in-hospital mortality, readmission rate, duration of hospital stay and ICU admission, non-infectious complications, improvement of quality of life and reduction of costs.;Primary end point(s): The primary endpoint of the SELECT trial is anastomotic leakage and/or anastomotic abscess, defined as clinical and/or radiological evidence of anastomotic dehiscence requiring surgical or radiological (re)intervention. ;Timepoint(s) of evaluation of this end point: 6 weeks after the primary operation | — |
Countries
Netherlands
Contacts
Public ContactVU medical center
VU medical center
Outcome results
None listed