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

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03436719
• Other study ID #: 76
• Status: Recruiting
• Phase: N/A
• Start date: November 6, 2017
• Est. completion date: August 31, 2020

Study information

• Verified date: March 2019
• Source: State Scientific Centre of Coloproctology, Russian Federation
• Contact: Evgeny Rybakov, Dr.Med.Sc.
• Phone: +7 499 199 86 43
• Email: erybakov[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: August 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have a planned of resection of rectum

• Have signed approved informed consent form for the study.

Exclusion Criteria:

• Significant simultaneous surgical procedure (e.g., liver resection of metastasis)

• Bacterial infection at the time of surgery or antimicrobial therapy up to 4 weeks before surgery

• Preoperative severe impairment in renal function (creatinine clearance (MDRD) < 30 ml/min)

• Allergy on the study drugs .

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

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
• Intravenous antibiotic
Cefoperazone - 1000 mg intravenously for 30-90 minutes before surgery
• Mechanical Bowel Preparation
Beginning of MBP at 4 p.m. in a day before surgery

Locations

Country	Name	City	State
Russian Federation	State Scientific Centre of Coloproctology	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
State Scientific Centre of Coloproctology, Russian Federation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Surgical Site Infection		0 to 30 days