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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04013841
• Other study ID #: BowelPrepMicrobiome
• Status: Completed
• Phase: N/A
• Start date: April 8, 2021
• Est. completion date: November 1, 2023

Study information

• Verified date: November 2023
• Source: Vilnius University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 1, 2023
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
Lithuania	National Cancer Institute	Vilnius

Sponsors (2)

Lead Sponsor	Collaborator
Vilnius University	National Cancer Institute (NCI)

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intestinal microbiome composition	Significant differences in the beta-diversity of the intestinal microbiome between oral and enema groups	6 days after surgery
Secondary	Intestinal microbiome composition	Significant differences in the beta-diversity of the intestinal microbiome between oral and enema groups	30 days after surgery
Secondary	Intestinal microbiome composition	Significant differences in the alpha-diversity of the intestinal microbiome between oral and enema groups	6 and 30 days after surgery