NCT03436719

Antibiotic Prophylaxis in Rectal Cancer Surgery: Oral With Intravenous Versus Intravenous Antibiotics.

Randomized Controlled Trial of Antibiotic Prophylaxis in Rectal Cancer Surgery: Oral With Intravenous Versus Intravenous Antibiotics.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 280 (estimated)
• Sponsor: State Scientific Centre of Coloproctology, Russian Federation · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, controlled, parallel study to determine the efficiency of oral antibiotics in reduction of surgical site infection (SSI) in rectal cancer surgery.

Detailed description

Patients undergoing rectal cancer surgery in a single centre will assigned randomly to combined preoperative oral antibiotics (metronidazole and erythromycin) and perioperative intravenous antibiotics (cefmetazole) (oral+intravenous group) or to perioperative intravenous antibiotics (cefmetazole) alone (intravenous group). The primary endpoint is the overall rate of SSI.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
DRUG	Oral antibiotic	Metronidazole - 500 mg and Erythromycin - 500 mg per os \*3 times at 5 p.m.; 8 p.m., 11 p.m. in a day before surgery
DRUG	Intravenous antibiotic	Cefoperazone - 1000 mg intravenously for 30-90 minutes before surgery
DRUG	Mechanical Bowel Preparation	Beginning of MBP at 4 p.m. in a day before surgery

Timeline

• Start date: 2017-11-06
• Primary completion: 2020-07-31
• Completion: 2020-08-31
• First posted: 2018-02-19
• Last updated: 2019-03-05

Locations

1 site across 1 country: Russia