AntibioticMECCANCT03563586
Mechanical Bowel Preparation With or Without Oral Antibiotics for Colorectal Cancer Surgery
A study testing Bowel Preparation plus antibiotics and Bowel Preparation in people with Antibiotic and Bowel Cancer, run by National and Kapodistrian University of Athens at 1 site in Greece.
Trial summary
Investigation of the role of adding oral antibiotics to preoperative mechanical bowel preparation before colorectal surgery for cancer. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Antibiotic, Bowel Cancer, Colorectal Cancer
- What is being tested?
- Bowel Preparation plus antibiotics and 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
- 210 participants
- Where
- 1 siteGreece
- Study dates
- 1 Apr 2018to 1 Jun 2021
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled colorectal cancer surgery
Who cannot join
- Emergency surgery
- Obstructive and perforated cancer
- Intolerance to bowel preparation regimen
- Allergies to orally administered antibiotics
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
NKUAthens
Athens, 11528
George Theodoropoulos, 6945463593
About this study
Official title: Prospective Randomized Monocentric Trial of Mechanical Bowel Preparation Alone vs Mechanical Bowel Preparation Combined With Oral Antibiotics Before Colorectal Resections for Cancer
Investigation of the role of adding oral antibiotics to preoperative mechanical bowel preparation before colorectal surgery for cancer.
Read the detailed description
The aim of the study is to investigate whether the addition of oral antibiotics to Mechanical Bowel Preparation (MBP) prior to colorectal cancer surgical procedures reduce the superfical and deep surgical site (SSI) infectious complications. The study is prospective and is designed in a randomized single-blinded controlled fashion. It is taking place at one academic surgical unit of Athens Medical School, located at a tertiary referal institution. Patients scheduled to undergo an elective surgical resection for colon or rectal cancer will be allocated to either formal MBP the day before surgery or a combined MBP with administration of oral antibiotics. Exclusion criteria are the following: emergency surgery, obstructive or perforated cancer, patients intolerance to bowel preparation regimen and allergies to orally administered antibiotics.
Intervention arms: Patients will be randomised into two groups, concealed from the treating surgeon.
Group A:
Preoperative oral antibiotic therapy with rifaximin 400 mg plus metronidazole 500mg the day prior to surgery at 2:00, 3:00 and 10:00 pm, with MBP (2 vials sodium phospate 45ml at 1:00 and 7:00 pm)
Group B:
MBP (2 vials sodium phospate 45ml at 1:00 and 7:00 pm) alone Both groups will receive iv antibiotics (cefoxitin 2 gr plus metronidazole 500gr) perioperatively and discontinuation within 24 hours.
Outcome measures: The primary end point is surgical site infection (SSI), including (i) superficial wound infection, (ii) deep wound infection, and (iii) intrabdominal infection (contaminated fluid or pus collection) within 30 days of the procedure (decrease 3% in the rate) Secondary measures: Anastomotic leaks, other surgical and non-surgical compliactions, hospital length of stay, readmission rate, patients' preparation tolerance, preparation regimens side-effects, time to beginning of adjuvant treatment for colorectal cancer.
Sample Size: It is estimated that 105 patients per treatment arm are needed.
- Conditions
- Antibiotic, Bowel Cancer, Colorectal Cancer, Surgical Site Infection
- Being tested
- Bowel Preparation plus antibiotics, Bowel Preparation
- Keywords
- oral antibiotic, mechanical bowel preparation, colorectal cancer, surgical site infection
- Medical subject headings
- Intestinal Neoplasms, Colorectal Neoplasms, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bowel Preparation plus antibioticsOther
Preoperative oral antibiotic therapy with rifaximin 400 mg plus metronidazole 500mg the day prior to surgery at 2:00, 3:00 and 10:00 pm, with mechanical bowel preparation (2 vials sodium phospate 45ml at 1:00 and 7:00 pm)
Bowel PreparationOther
Mechanical Bowel Preparation (2 vials sodium phospate 45ml at 1:00 and 7:00 pm) alone Both groups will receive iv antibiotics (cefoxitin 2 gr plus metronidazole 500gr) perioperatively and discontinuation within 24 hours
| Study group | Role | What they receive |
|---|---|---|
| Bowel Preparation plus antibiotics | Active comparator | Preoperative oral antibiotic therapy with rifaximin 400 mg plus metronidazole 500mg the day prior to surgery at 2:00, 3:00 and 10:00 pm, with mechanical bowel preparation (2 vials sodium phospate 45ml at 1:00 and 7:00 pm) Receives: Other: Bowel Preparation plus antibiotics |
| Bowel Preparation | Other | Preoperative mechanical bowel preparation (2 vials sodium phospate 45ml at 1:00 and 7:00 pm) Receives: Other: Bowel Preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Site Infections
Surgical Site Infections
Measured: 30 days
Secondary outcomes (7)
Anastomotic leaks
Anastomotic leaks
Measured: 30 days
Other surgical and non-surgical compliactions
Other surgical and non-surgical compliactions
Measured: 30 days
Hospital length of stay
Hospital length of stay
Measured: 30 days
Readmission rate
Readmission rate
Measured: 30 days
Patients' preparation tolerance
Patients' preparation tolerance
Measured: 30 days
Preparation regimens side-effects
Preparation regimens side-effects
Measured: 30 days
Time to beginning of adjuvant treatment for colorectal cancer
Time to beginning of adjuvant treatment for colorectal cancer
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2018
- Study start1 Apr 2018
- Primary completion1 Apr 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AntibioticStudies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe sponsor's other registered studies.
- 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
- Sequential
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, George Theodoropoulos, National and Kapodistrian University of Athens
- Investigators
- George Theodoropoulos, Principal investigator, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03563586
- Sponsor's protocol ID
- 56/14-3-2018
- Acronym
- MECCA
- Status last verified
- Sep 2020
- First submitted
- 9 Jun 2018
- Last updated
- 11 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Frountzas M, Michalopoulou V, Georgiou G, Kanata D, Matiatou M, Kimpizi D, Matthaiou G, Spiliotopoulos S, Vouros D, Toutouzas KG, Theodoropoulos GE. The Impact of Mechanical Bowel Preparation and Oral Antibiotics in Colorectal Cancer Surgery (MECCA Study): A Prospective Randomized Clinical Trial. J Clin Med. 2024 Feb 19;13(4):1162. doi: 10.3390/jcm13041162.
PubMed 38398474Willis MA, Toews I, Soltau SL, Kalff JC, Meerpohl JJ, Vilz TO. Preoperative combined mechanical and oral antibiotic bowel preparation for preventing complications in elective colorectal surgery. Cochrane Database Syst Rev. 2023 Feb 7;2(2):CD014909. doi: 10.1002/14651858.CD014909.pub2.
PubMed 36748942
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Monocentric Trial of Mechanical Bowel Preparation Alone vs Mechanical Bowel Preparation Combined With Oral Antibiotics Before Colorectal Resections for Cancer
- ClinicalTrials.gov ID
- NCT03563586
- Acronym / sponsor ID
- MECCA / 56/14-3-2018
- Conditions
- Antibiotic, Bowel Cancer, Colorectal Cancer, Surgical Site Infection
- Keywords
- oral antibiotic, mechanical bowel preparation, colorectal cancer, surgical site infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 20 Jun 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.
Investigation of the role of adding oral antibiotics to preoperative mechanical bowel preparation before colorectal surgery for cancer.
Detailed description
The aim of the study is to investigate whether the addition of oral antibiotics to Mechanical Bowel Preparation (MBP) prior to colorectal cancer surgical procedures reduce the superfical and deep surgical site (SSI) infectious complications. The study is prospective and is designed in a randomized single-blinded controlled fashion. It is taking place at one academic surgical unit of Athens Medical School, located at a tertiary referal institution. Patients scheduled to undergo an elective surgical resection for colon or rectal cancer will be allocated to either formal MBP the day before surgery or a combined MBP with administration of oral antibiotics. Exclusion criteria are the following: emergency surgery, obstructive or perforated cancer, patients intolerance to bowel preparation regimen and allergies to orally administered antibiotics.
Intervention arms: Patients will be randomised into two groups, concealed from the treating surgeon.
Group A:
Preoperative oral antibiotic therapy with rifaximin 400 mg plus metronidazole 500mg the day prior to surgery at 2:00, 3:00 and 10:00 pm, with MBP (2 vials sodium phospate 45ml at 1:00 and 7:00 pm)
Group B:
MBP (2 vials sodium phospate 45ml at 1:00 and 7:00 pm) alone Both groups will receive iv antibiotics (cefoxitin 2 gr plus metronidazole 500gr) perioperatively and discontinuation within 24 hours.
Outcome measures: The primary end point is surgical site infection (SSI), including (i) superficial wound infection, (ii) deep wound infection, and (iii) intrabdominal infection (contaminated fluid or pus collection) within 30 days of the procedure (decrease 3% in the rate) Secondary measures: Anastomotic leaks, other surgical and non-surgical compliactions, hospital length of stay, readmission rate, patients' preparation tolerance, preparation regimens side-effects, time to beginning of adjuvant treatment for colorectal cancer.
Sample Size: It is estimated that 105 patients per treatment arm are needed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bowel Preparation plus antibiotics | Active comparator | Other: Bowel Preparation plus antibioticsPreoperative oral antibiotic therapy with rifaximin 400 mg plus metronidazole 500mg the day prior to surgery at 2:00, 3:00 and 10:00 pm, with mechanical bowel preparation (2 vials sodium phospate 45ml at 1:00 and 7:00 pm) |
| Bowel Preparation | Other | Other: Bowel PreparationPreoperative mechanical bowel preparation (2 vials sodium phospate 45ml at 1:00 and 7:00 pm) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Scheduled colorectal cancer surgery
Key exclusion criteria (4 listed)
- Emergency surgery
- Obstructive and perforated cancer
- Intolerance to bowel preparation regimen
- Allergies to orally administered antibiotics
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 |
|---|---|---|
| Bowel Preparation plus antibioticsPreoperative oral antibiotic therapy with rifaximin 400 mg plus metronidazole 500mg the day prior to surgery at 2:00, 3:00 and 10:00 pm, with mechanical bowel preparation (2 vials sodium phospate 45ml at 1:00 and 7:00 pm) | Other | Bowel Preparation plus antibiotics |
| Bowel PreparationMechanical Bowel Preparation (2 vials sodium phospate 45ml at 1:00 and 7:00 pm) alone Both groups will receive iv antibiotics (cefoxitin 2 gr plus metronidazole 500gr) perioperatively and discontinuation within 24 hours | Other | Bowel Preparation |
Primary outcome
Surgical Site Infections
Time frame: 30 days
Surgical Site Infections
7 secondary outcomes
Anastomotic leaks
Time frame: 30 days
Other surgical and non-surgical compliactions
Time frame: 30 days
Hospital length of stay
Time frame: 30 days
Readmission rate
Time frame: 30 days
Patients' preparation tolerance
Time frame: 30 days
Preparation regimens side-effects
Time frame: 30 days
Time to beginning of adjuvant treatment for colorectal cancer
Time frame: 60 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2020.
- Derived from this study: PubMed 38398474Frountzas M, Michalopoulou V, Georgiou G, Kanata D, Matiatou M, Kimpizi D, Matthaiou G, Spiliotopoulos S, Vouros D, Toutouzas KG, Theodoropoulos GE. The Impact of Mechanical Bowel Preparation and Oral Antibiotics in Colorectal Cancer Surgery (MECCA Study): A Prospective Randomized Clinical Trial. J Clin Med. 2024 Feb 19;13(4):1162. doi: 10.3390/jcm13041162.
- Derived from this study: PubMed 36748942Willis MA, Toews I, Soltau SL, Kalff JC, Meerpohl JJ, Vilz TO. Preoperative combined mechanical and oral antibiotic bowel preparation for preventing complications in elective colorectal surgery. Cochrane Database Syst Rev. 2023 Feb 7;2(2):CD014909. doi: 10.1002/14651858.CD014909.pub2.
- 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.
George Theodoropoulos principal investigator
National and Kapodistrian University of Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bowel Preparation plus antibiotics and Bowel Preparation in people with Antibiotic and Bowel Cancer, run by National and Kapodistrian University of Athens at 1 site in Greece.
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 1 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 11 Sep 2020. 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 Greece. 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 George Theodoropoulos (+306945463593, georgetheocrs@live.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Site Infections (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03563586, which also lists 2 linked publications.
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 11 Sep 2020.