NCT03436719

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
280

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 6, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 19, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

March 5, 2019

Status Verified

March 1, 2019

Enrollment Period

2.7 years

First QC Date

February 5, 2018

Last Update Submit

March 4, 2019

Conditions

Rectal Cancer

Keywords

Surgical Site InfectionRectal Cancer SurgeryOral AntibioticAntibiotic Prophylaxis

Outcome Measures

Primary Outcomes (1)

  • Rate of Surgical Site Infection

    0 to 30 days

Study Arms (2)

Oral with Intravenous

EXPERIMENTAL

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

Drug: Oral antibioticDrug: Intravenous antibioticDrug: Mechanical Bowel Preparation

Intravenous

ACTIVE COMPARATOR

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

Drug: Intravenous antibioticDrug: Mechanical Bowel Preparation

Interventions

Oral antibioticDRUG

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

Also known as: Metronidazole, Erythromycin
Oral with Intravenous
Intravenous antibioticDRUG

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

Also known as: Cefoperazone
IntravenousOral with Intravenous
Mechanical Bowel PreparationDRUG

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

Also known as: polyethylene glycol
IntravenousOral with Intravenous

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have a planned of resection of rectum
  • Have signed approved informed consent form for the study.

You may not qualify if:

  • 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 .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State Scientific Centre of Coloproctology

Moscow, 123423, Russia

RECRUITING

MeSH Terms

Conditions

Rectal NeoplasmsSurgical Wound Infection

Interventions

Anti-Bacterial AgentsMetronidazoleErythromycinCefoperazonePolyethylene Glycols

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal DiseasesWound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anti-Infective AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesNitroimidazolesNitro CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMacrolidesPolyketidesLactonesCefamandoleCephalosporinsbeta-LactamsLactamsAmidesThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingEthylene GlycolsGlycolsAlcoholsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Central Study Contacts

Evgeny Rybakov, Dr.Med.Sc.

CONTACT

+7 499 199 86 43erybakov@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Med. Sc. State Scientific Centre of Coloproctology, Head of Surgical department of oncoproctology, Moscow, Russian Federation

Study Record Dates

First Submitted

February 5, 2018

First Posted

February 19, 2018

Study Start

November 6, 2017

Primary Completion

July 31, 2020

Study Completion

August 31, 2020

Last Updated

March 5, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)