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

Vilnius University

Status: Completed

Conditions: Colorectal Cancer

Treatments: Other: Oral-agents/Enema

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04013841

BowelPrepMicrobiome

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Oral preparation

Experimental group

Description:

The bowel preparation prior to colorectal resection will be conducted using oral-agents

Treatment:

Other: Oral-agents/Enema

Enema preparation

Experimental group

Description:

The bowel preparation prior to colorectal resection will be conducted using rectal enema

Treatment:

Other: Oral-agents/Enema