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

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

Detailed Description
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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.

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

Conditions
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Antibiotic, Bowel Cancer, Colorectal Cancer, Surgical Site Infection

Intervention / Treatment
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* Other: Bowel Preparation plus antibiotics
* Other: Bowel Preparation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled colorectal cancer surgery Exclusion Criteria: Emergency surgery Obstructive and perforated cancer Intolerance to bowel preparation regimen Allergies to orally administered antibiotics

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bowel Preparation plus antibiotics<br>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<br>* 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)<br>|
| Other: Bowel Preparation<br>Preoperative mechanical bowel preparation (2 vials sodium phospate 45ml at 1:00 and 7:00 pm) | Other: Bowel Preparation<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical Site Infections | Surgical Site Infections | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anastomotic leaks | Anastomotic leaks | 30 days | 
| Other surgical and non-surgical compliactions | Other surgical and non-surgical compliactions | 30 days | 
| Hospital length of stay | Hospital length of stay | 30 days | 
| Readmission rate | Readmission rate | 30 days | 
| Patients' preparation tolerance | Patients' preparation tolerance | 30 days | 
| Preparation regimens side-effects | Preparation regimens side-effects | 30 days | 
| Time to beginning of adjuvant treatment for colorectal cancer | Time to beginning of adjuvant treatment for colorectal cancer | 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oral antibiotic, mechanical bowel preparation, colorectal cancer, surgical site infection