Bowel Preparation Impact on the Intestinal Microbiome: Oral Preparation vs Enema

Study Overview
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Brief Summary
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Mechanical bowel preparation for left-sided colorectal surgery remains standard in most cases. However, there are some discrepancies on how to prepare the bowl, while rectal enema and oral agents are both available methods. The knowledge of intestinal microbiome role on surgical outcomes is increasing, since few recent reports linked microbiome composition to postoperative complications, such as anastomotic insufficiency. Although, it is not clear how the bowel preparation affects the gut microbiome. Therefore, different bowel preparation techniques impact on gut microbiome will be studied.

Official Title
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Bowel Preparation for Left Side Colon Surgery Impact on the Intestinal Microbiome: Oral Preparation vs Enema

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Other: Oral-agents/Enema


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 y.; Signed informed consent; Left-side colorectal resection for colorectal cancer; Exclusion Criteria: Anticipated ileostoma; Allergy to oral preparation agents; Multivisceral surgery; Emergency surgery; History of inflammatory bowel disease; History of surgery disrupting gastrointestinal tract integrity; Signs of tumor obturating the lumen of the bowel; Pregnancy;

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral preparation<br>The bowel preparation prior to colorectal resection will be conducted using oral-agents | Other: Oral-agents/Enema<br>* Oral-agents for mechanical bowel preparation prior to left-side colorectal resection Enema for mechanical bowel preparation prior to left-side colorectal resection<br>|
| Experimental: Enema preparation<br>The bowel preparation prior to colorectal resection will be conducted using rectal enema | Other: Oral-agents/Enema<br>* Oral-agents for mechanical bowel preparation prior to left-side colorectal resection Enema for mechanical bowel preparation prior to left-side colorectal resection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intestinal microbiome composition | Significant differences in the beta-diversity of the intestinal microbiome between oral and enema groups | 6 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intestinal microbiome composition | Significant differences in the beta-diversity of the intestinal microbiome between oral and enema groups | 30 days after surgery | 
| Intestinal microbiome composition | Significant differences in the alpha-diversity of the intestinal microbiome between oral and enema groups | 6 and 30 days after surgery |