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

Primary Purpose

Colorectal Cancer

Status

Active

Phase

Not Applicable

Locations

Lithuania

Study Type

Interventional

Intervention

Oral-agents/Enema

About this trial

This is an interventional treatment trial for Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

National Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Oral preparation

Enema preparation

Arm Description

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

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

Outcomes

Primary Outcome Measures

Intestinal microbiome composition

Significant differences in the beta-diversity of the intestinal microbiome between oral and enema groups

Secondary Outcome Measures

Intestinal microbiome composition

Significant differences in the beta-diversity of the intestinal microbiome between oral and enema groups

Intestinal microbiome composition

Significant differences in the alpha-diversity of the intestinal microbiome between oral and enema groups

Full Information

NCT ID

NCT04013841

First Posted

July 7, 2019

Last Updated

October 11, 2022

Sponsor

Vilnius University

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT04013841

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

April 8, 2021 (Actual)

Primary Completion Date

August 1, 2022 (Actual)

Study Completion Date

May 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Vilnius University

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Care ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Oral preparation

Arm Type

Experimental

Arm Description

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

Arm Title

Enema preparation

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Oral-agents/Enema

Intervention Description

Oral-agents for mechanical bowel preparation prior to left-side colorectal resection Enema for mechanical bowel preparation prior to left-side colorectal resection

Primary Outcome Measure Information:

Title

Intestinal microbiome composition

Description

Significant differences in the beta-diversity of the intestinal microbiome between oral and enema groups

Time Frame

6 days after surgery

Secondary Outcome Measure Information:

Title

Intestinal microbiome composition

Description

Significant differences in the beta-diversity of the intestinal microbiome between oral and enema groups

Time Frame

30 days after surgery

Title

Intestinal microbiome composition

Description

Significant differences in the alpha-diversity of the intestinal microbiome between oral and enema groups

Time Frame

6 and 30 days after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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;

Facility Information:

Facility Name

National Cancer Institute

City

Vilnius

Country

Lithuania

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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