Clinical trial NCT03563586: Mechanical Bowel Preparation With or Without Oral Antibiotics for Colorectal Cancer Surgery
Official title: Prospective Randomized Monocentric Trial of Mechanical Bowel Preparation Alone vs Mechanical Bowel Preparation Combined With Oral Antibiotics Before Colorectal Resections for Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Antibiotic
Bowel Cancer
Colorectal Cancer
Surgical Site Infection
Keywords: oral antibiotic
mechanical bowel preparation
colorectal cancer
surgical site infection
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
First posted: 2018-06-20
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Surgical Site Infections
timeFrame: 30 days
Secondary outcomes:
measure: Anastomotic leaks
timeFrame: 30 days
measure: Other surgical and non-surgical compliactions
timeFrame: 30 days
measure: Hospital length of stay
timeFrame: 30 days
measure: Readmission rate
timeFrame: 30 days
measure: Patients' preparation tolerance
timeFrame: 30 days
measure: Preparation regimens side-effects
timeFrame: 30 days
measure: Time to beginning of adjuvant treatment for colorectal cancer
timeFrame: 60 days
Other outcomes:
Locations:
city: Athens
country: Greece
facility: NKUAthens
Study officials:
affiliation: National and Kapodistrian University of Athens
name: George Theodoropoulos
role: PRINCIPAL_INVESTIGATOR
References: