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

Colorectal Cancer Clinical Trial

— MECCA  

Official title:

Prospective Randomized Monocentric Trial of Mechanical Bowel Preparation Alone vs Mechanical Bowel Preparation Combined With Oral Antibiotics Before Colorectal Resections for Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03563586
• Other study ID #: 56/14-3-2018
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: June 1, 2021

Study information

• Verified date: September 2020
• Source: National and Kapodistrian University of Athens
• Contact: George Theodoropoulos
• Phone: +306945463593
• Email: georgetheocrs[@]live.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: June 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Scheduled colorectal cancer surgery

Exclusion Criteria:

• Emergency surgery

• Obstructive and perforated cancer

• Intolerance to bowel preparation regimen

• Allergies to orally administered antibiotics

Related Conditions & MeSH terms

• Antibiotic
• Bowel Cancer
• Colorectal Cancer
• Colorectal Neoplasms
• Surgical Site Infection
• Surgical Wound Infection

Intervention

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
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

Locations

Country	Name	City	State
Greece	NKUAthens	Athens

Sponsors (1)

Lead Sponsor	Collaborator
National and Kapodistrian University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical Site Infections	Surgical Site Infections	30 days
Secondary	Anastomotic leaks	Anastomotic leaks	30 days
Secondary	Other surgical and non-surgical compliactions	Other surgical and non-surgical compliactions	30 days
Secondary	Hospital length of stay	Hospital length of stay	30 days
Secondary	Readmission rate	Readmission rate	30 days
Secondary	Patients' preparation tolerance	Patients' preparation tolerance	30 days
Secondary	Preparation regimens side-effects	Preparation regimens side-effects	30 days
Secondary	Time to beginning of adjuvant treatment for colorectal cancer	Time to beginning of adjuvant treatment for colorectal cancer	60 days