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Mechanical Bowel Preparation With or Without Oral Antibiotics for Colorectal Cancer Surgery (MECCA)

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ClinicalTrials.gov Identifier: NCT03563586
Recruitment Status : Recruiting
First Posted : June 20, 2018
Last Update Posted : July 20, 2018
Sponsor:
Information provided by (Responsible Party):
George Theodoropoulos, National and Kapodistrian University of Athens

Brief Summary:
Investigation of the role of adding oral antibiotics to preoperative mechanical bowel preparation before colorectal surgery for cancer.

Condition or disease Intervention/treatment Phase
Antibiotic Bowel Cancer Colorectal Cancer Surgical Site Infection Other: Bowel Preparation plus antibiotics Other: Bowel Preparation Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prospective Randomized Monocentric Trial of Mechanical Bowel Preparation Alone vs Mechanical Bowel Preparation Combined With Oral Antibiotics Before Colorectal Resections for Cancer
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Active Comparator: Bowel Preparation plus antibiotics
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)
Other: Bowel Preparation plus antibiotics
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 Preparation
Preoperative mechanical bowel preparation (2 vials sodium phospate 45ml at 1:00 and 7:00 pm)
Other: Bowel Preparation
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




Primary Outcome Measures :
  1. Surgical Site Infections [ Time Frame: 30 days ]
    Surgical Site Infections


Secondary Outcome Measures :
  1. Anastomotic leaks [ Time Frame: 30 days ]
    Anastomotic leaks

  2. Other surgical and non-surgical compliactions [ Time Frame: 30 days ]
    Other surgical and non-surgical compliactions

  3. Hospital length of stay [ Time Frame: 30 days ]
    Hospital length of stay

  4. Readmission rate [ Time Frame: 30 days ]
    Readmission rate

  5. Patients' preparation tolerance [ Time Frame: 30 days ]
    Patients' preparation tolerance

  6. Preparation regimens side-effects [ Time Frame: 30 days ]
    Preparation regimens side-effects

  7. Time to beginning of adjuvant treatment for colorectal cancer [ Time Frame: 60 days ]
    Time to beginning of adjuvant treatment for colorectal cancer



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Scheduled colorectal cancer surgery

Exclusion Criteria:

  • Emergency surgery
  • Obstructive and perforated cancer
  • Intolerance to bowel preparation regimen
  • Allergies to orally administered antibiotics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03563586


Contacts
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Contact: George Theodoropoulos +306945463593 georgetheocrs@live.com
Contact: Georgia Georgiou +306945292510 georgia_cy@hotmail.com

Locations
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Greece
NKUAthens Recruiting
Athens, Greece, 11528
Contact: George Theodoropoulos    6945463593      
Sponsors and Collaborators
National and Kapodistrian University of Athens
Investigators
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Principal Investigator: George Theodoropoulos National and Kapodistrian University of Athens

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Responsible Party: George Theodoropoulos, Associate Professor, National and Kapodistrian University of Athens
ClinicalTrials.gov Identifier: NCT03563586     History of Changes
Other Study ID Numbers: 56/14-3-2018
First Posted: June 20, 2018    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by George Theodoropoulos, National and Kapodistrian University of Athens:
oral antibiotic
mechanical bowel preparation
colorectal cancer
surgical site infection

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Intestinal Diseases
Surgical Wound Infection
Infection
Digestive System Diseases
Gastrointestinal Diseases
Rectal Diseases
Wound Infection
Postoperative Complications
Pathologic Processes
Anti-Bacterial Agents
Metronidazole
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Antiprotozoal Agents
Antiparasitic Agents