Does Administration of Antibiotics in Patients Undergoing Surgery for Colorectal Cancer Result in Less Complications and Better Prognosis?

• Status: Terminated
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objectives of this randomized clinical trial are to evaluate if perioperative SDD can reduce clinical anastomotic leakage rate and its septic consequences as well as other infectious complications. By reduction of septic complications long-term oncological outcome might simultaneously improve.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: H. Jaap Bonjer, PhD
• Collaborators: Dutch Digestive Diseases Foundation; MaagLeverDarm Stichting
• Treatments: Amphotericin B; Colistin; Liposomal amphotericin B; Tobramycin

Criteria

Inclusion Criteria:

• Elective colon and rectal cancer surgery with primary anastomosis

• Or elective colorectal surgery for suspected carcinoma

• No evidence of distant metastases (preoperative CT-abdomen and X-thorax or CTthorax)

• Procedure either with or without diverting stoma

• Both laparoscopic and open surgery

• Informed consent

• Aged 18 years or older

Exclusion Criteria:

• Previous colorectal malignancy

• Current malignancy which is now undergoing treatment

• Inflammatory bowel disease (Crohn's disease or ulcerative colitis)

• Previous surgery for diverticular disease

• Performance status ASA 4 or higher (American Society for Anaesthesiologists)

• Expected adverse reactions/allergies for study medication

• Prednisone use > 5 mg per day

• Familial adenomatous polyposis coli (FAP; Lynch syndrome), Hereditary Non Polyposis Colorectal Cancer (HNPCC)

• Mental disorder/unable to give informed consent

• Pregnancy