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

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Other: Oral-agents/Enema

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lithuania
  • Vilnius, Lithuania
    • National Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral preparation; The bowel preparation prior to colorectal resection will be conducted using oral-agents	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
Experimental: Enema preparation; The bowel preparation prior to colorectal resection will be conducted using rectal enema	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Vilnius University
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2021
• Primary Completion (Actual): August 1, 2022
• Study Completion (Actual): November 1, 2023

Study Registration Dates

• First Submitted: July 7, 2019
• First Submitted That Met QC Criteria: July 7, 2019
• First Posted (Actual): July 10, 2019

Study Record Updates

• Last Update Posted (Actual): November 8, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: BowelPrepMicrobiome

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No