Rectal CancerNCT03436719
Antibiotic Prophylaxis in Rectal Cancer Surgery: Oral With Intravenous Versus Intravenous Antibiotics.
A study testing Oral antibiotic, Intravenous antibiotic and Mechanical Bowel Preparation in people with Rectal Cancer, run by State Scientific Centre of Coloproctology, Russian Federation at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Oral antibiotic, Intravenous antibiotic and Mechanical Bowel Preparation
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteRussia
- Study dates
- 6 Nov 2017to 31 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a planned of resection of rectum
- Have signed approved informed consent form for the study.
Who cannot join
- 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 .
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
State Scientific Centre of Coloproctology
Moscow, 123423
About this study
Official title: Randomized Controlled Trial of Antibiotic Prophylaxis in Rectal Cancer Surgery: Oral With Intravenous Versus Intravenous Antibiotics.
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.
Read the 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
- Being tested
- Oral antibiotic, Intravenous antibiotic, Mechanical Bowel Preparation
- Keywords
- Surgical Site Infection, Rectal Cancer Surgery, Oral Antibiotic, Antibiotic Prophylaxis
- Medical subject headings
- Rectal Neoplasms, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral antibioticDrug
Also called Metronidazole, Erythromycin
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 antibioticDrug
Also called Cefoperazone
Cefoperazone - 1000 mg intravenously for 30-90 minutes before surgery
Mechanical Bowel PreparationDrug
Also called polyethylene glycol
Beginning of MBP at 4 p.m. in a day before surgery
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Oral antibiotic; Drug: Intravenous antibiotic; Drug: Mechanical Bowel Preparation |
| Intravenous | Active comparator | Intravenous dose cefoperazone before surgery (30-90 min) and additional doses every third hour during surgery Receives: Drug: Intravenous antibiotic; Drug: Mechanical Bowel Preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Surgical Site Infection
Measured: 0 to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start6 Nov 2017
- Primary completion31 Jul 2020 (estimated)
- Study completion31 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State Scientific Centre of Coloproctology, Russian Federation
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Rybakov Evgeny, MD, State Scientific Centre of Coloproctology, Russian Federation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03436719
- Sponsor's protocol ID
- 76
- Status last verified
- Mar 2019
- First submitted
- 5 Feb 2018
- Last updated
- 5 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Antibiotic Prophylaxis in Rectal Cancer Surgery: Oral With Intravenous Versus Intravenous Antibiotics.
- ClinicalTrials.gov ID
- NCT03436719
- Acronym / sponsor ID
- 76
- Conditions
- Rectal Cancer
- Keywords
- Surgical Site Infection, Rectal Cancer Surgery, Oral Antibiotic, Antibiotic Prophylaxis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- State Scientific Centre of Coloproctology, Russian FederationOther government
- Study start
- 6 Nov 2017 (actual)
- Primary completion
- 31 Jul 2020 (estimated)
- Study completion
- 31 Aug 2020 (estimated)
- First posted
- 19 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral with Intravenous | Experimental | Drug: Oral antibiotic, Drug: Intravenous antibiotic, Drug: Mechanical Bowel PreparationOral 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 |
| Intravenous | Active comparator | Drug: Intravenous antibiotic, Drug: Mechanical Bowel PreparationIntravenous dose cefoperazone before surgery (30-90 min) and additional doses every third hour during surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Have a planned of resection of rectum
- Have signed approved informed consent form for the study.
Key exclusion criteria (4 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral antibioticAlso: Metronidazole, ErythromycinMetronidazole - 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 | Oral with Intravenous |
| Intravenous antibioticAlso: CefoperazoneCefoperazone - 1000 mg intravenously for 30-90 minutes before surgery | Drug | Intravenous, Oral with Intravenous |
| Mechanical Bowel PreparationAlso: polyethylene glycolBeginning of MBP at 4 p.m. in a day before surgery | Drug | Intravenous, Oral with Intravenous |
Primary outcome
Rate of Surgical Site Infection
Time frame: 0 to 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral antibiotic, Intravenous antibiotic and Mechanical Bowel Preparation in people with Rectal Cancer, run by State Scientific Centre of Coloproctology, Russian Federation at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Evgeny Rybakov, Dr.Med.Sc. (+7 499 199 86 43, erybakov@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Surgical Site Infection (time frame: 0 to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2019.