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

Overview

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.

Full Title of Study: “Bowel Preparation for Left Side Colon Surgery Impact on the Intestinal Microbiome: Oral Preparation vs Enema”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 1, 2022

Interventions

  • Other: Oral-agents/Enema
    • Oral-agents for mechanical bowel preparation prior to left-side colorectal resection Enema for mechanical bowel preparation prior to left-side colorectal resection

Arms, Groups and Cohorts

  • Experimental: Oral preparation
    • The bowel preparation prior to colorectal resection will be conducted using oral-agents
  • Experimental: Enema preparation
    • The bowel preparation prior to colorectal resection will be conducted using rectal enema

Clinical Trial Outcome Measures

Primary Measures

  • Intestinal microbiome composition
    • Time Frame: 6 days after surgery
    • Significant differences in the beta-diversity of the intestinal microbiome between oral and enema groups

Secondary Measures

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

Participating in This Clinical Trial

Inclusion Criteria

1. Age ≥ 18 y.; 2. Signed informed consent; 3. Left-side colorectal resection for colorectal cancer; Exclusion Criteria:

1. Anticipated ileostoma; 2. Allergy to oral preparation agents; 3. Multivisceral surgery; 4. Emergency surgery; 5. History of inflammatory bowel disease; 6. History of surgery disrupting gastrointestinal tract integrity; 7. Signs of tumor obturating the lumen of the bowel; 8. Pregnancy;

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Vilnius University
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Rimantas Bausys, Principle Investigator – Vilnius University

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