TerminatedPhase 4

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

Stopped: Superiority was no longer attainable

Netherlands485 participantsStarted 2013-01

Plain-language 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.

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

anastomotic leakage and/or abscess

Timeframe: 30 days postoperatively

Trial details

NCT IDNCT01740947

SponsorH. Jaap Bonjer, PhD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-03

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