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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 : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
George Theodoropoulos, National and Kapodistrian University of Athens

Tracking Information
First Submitted Date  ICMJE June 9, 2018
First Posted Date  ICMJE June 20, 2018
Last Update Posted Date August 26, 2019
Actual Study Start Date  ICMJE April 1, 2018
Estimated Primary Completion Date April 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2018)
Surgical Site Infections [ Time Frame: 30 days ]
Surgical Site Infections
Original Primary Outcome Measures  ICMJE
 (submitted: June 9, 2018)
Surgical Site Infections [ Time Frame: 30 days ]
Change History Complete list of historical versions of study NCT03563586 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2018)
  • Anastomotic leaks [ Time Frame: 30 days ]
    Anastomotic leaks
  • Other surgical and non-surgical compliactions [ Time Frame: 30 days ]
    Other surgical and non-surgical compliactions
  • Hospital length of stay [ Time Frame: 30 days ]
    Hospital length of stay
  • Readmission rate [ Time Frame: 30 days ]
    Readmission rate
  • Patients' preparation tolerance [ Time Frame: 30 days ]
    Patients' preparation tolerance
  • Preparation regimens side-effects [ Time Frame: 30 days ]
    Preparation regimens side-effects
  • Time to beginning of adjuvant treatment for colorectal cancer [ Time Frame: 60 days ]
    Time to beginning of adjuvant treatment for colorectal cancer
Original Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2018)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mechanical Bowel Preparation With or Without Oral Antibiotics for Colorectal Cancer Surgery
Official Title  ICMJE Prospective Randomized Monocentric Trial of Mechanical Bowel Preparation Alone vs Mechanical Bowel Preparation Combined With Oral Antibiotics Before Colorectal Resections for Cancer
Brief Summary 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Antibiotic
  • Bowel Cancer
  • Colorectal Cancer
  • Surgical Site Infection
Intervention  ICMJE
  • 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)
  • 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
Study Arms  ICMJE
  • 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)
    Intervention: Other: Bowel Preparation plus antibiotics
  • Bowel Preparation
    Preoperative mechanical bowel preparation (2 vials sodium phospate 45ml at 1:00 and 7:00 pm)
    Intervention: Other: Bowel Preparation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 9, 2018)
210
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2021
Estimated Primary Completion Date April 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Scheduled colorectal cancer surgery

Exclusion Criteria:

  • Emergency surgery
  • Obstructive and perforated cancer
  • Intolerance to bowel preparation regimen
  • Allergies to orally administered antibiotics
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: George Theodoropoulos +306945463593 georgetheocrs@live.com
Contact: Georgia Georgiou +306945292510 georgia_cy@hotmail.com
Listed Location Countries  ICMJE Greece
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03563586
Other Study ID Numbers  ICMJE 56/14-3-2018
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party George Theodoropoulos, National and Kapodistrian University of Athens
Study Sponsor  ICMJE National and Kapodistrian University of Athens
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: George Theodoropoulos National and Kapodistrian University of Athens
PRS Account National and Kapodistrian University of Athens
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP