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

NCT ID: NCT03436719

Last Updated: 2019-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-06

Study Completion Date

2020-08-31

Brief Summary

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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

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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

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Rectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Oral with Intravenous

Oral metronidazole and erythromycine administration on the day before surgery with intravenous cefoperazone before surgery (30-90 min) and additional doses every third hour during surgery

Group Type EXPERIMENTAL

Oral antibiotic

Intervention Type DRUG

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

Intervention Type DRUG

Cefoperazone - 1000 mg intravenously for 30-90 minutes before surgery

Mechanical Bowel Preparation

Intervention Type DRUG

Beginning of MBP at 4 p.m. in a day before surgery

Intravenous

Intravenous dose cefoperazone before surgery (30-90 min) and additional doses every third hour during surgery

Group Type ACTIVE_COMPARATOR

Intravenous antibiotic

Intervention Type DRUG

Cefoperazone - 1000 mg intravenously for 30-90 minutes before surgery

Mechanical Bowel Preparation

Intervention Type DRUG

Beginning of MBP at 4 p.m. in a day before surgery

Interventions

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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

Intervention Type DRUG

Intravenous antibiotic

Cefoperazone - 1000 mg intravenously for 30-90 minutes before surgery

Intervention Type DRUG

Mechanical Bowel Preparation

Beginning of MBP at 4 p.m. in a day before surgery

Intervention Type DRUG

Other Intervention Names

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Metronidazole Erythromycin Cefoperazone polyethylene glycol

Eligibility Criteria

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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 .
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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State Scientific Centre of Coloproctology, Russian Federation

OTHER_GOV

Sponsor Role lead

Responsible Party

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Rybakov Evgeny, MD

Dr. Med. Sc. State Scientific Centre of Coloproctology, Head of Surgical department of oncoproctology, Moscow, Russian Federation

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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State Scientific Centre of Coloproctology

Moscow, , Russia

Site Status RECRUITING

Countries

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Russia

Central Contacts

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Evgeny Rybakov, Dr.Med.Sc.

Role: CONTACT

+7 499 199 86 43

Other Identifiers

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76

Identifier Type: -

Identifier Source: org_study_id

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