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

NCT ID: NCT04013841

Last Updated: 2023-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-08
• Study Completion Date: 2023-11-01

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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Oral preparation

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

Group Type: EXPERIMENTAL

Oral-agents/Enema

Intervention Type: OTHER

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

2. Enema for mechanical bowel preparation prior to left-side colorectal resection

Enema preparation

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

Group Type: EXPERIMENTAL

Oral-agents/Enema

Intervention Type: OTHER

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

2. Enema for mechanical bowel preparation prior to left-side colorectal resection

Interventions

Oral-agents/Enema

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

2. Enema for mechanical bowel preparation prior to left-side colorectal resection

Intervention Type: OTHER

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Vilnius University

OTHER

Sponsor Role: lead

Responsible Party

Rimantas Bausys

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

National Cancer Institute

Vilnius, , Lithuania

Countries

Lithuania

References

Rauduvyte K, Kazlauskaite P, Kryzauskas M, Ignatavicius P, Poskus T, Sabaliauskaite R, Mlynska A, Sestokaite A, Luksta M, Bausys R, Jakubauskas M, Bausys A. Preoperative TNF-alpha predicts uneventful postoperative outcomes in patients undergoing colorectal cancer surgery. Sci Rep. 2025 Jul 1;15(1):21878. doi: 10.1038/s41598-025-06667-6.

Reference Type: DERIVED

PMID: 40596170 (View on PubMed)

Zukauskaite K, Horvath A, Gricius Z, Kvietkauskas M, Bausys B, Dulskas A, Kuliavas J, Bausys R, Letautiene SR, Vaicekauskaite I, Sabaliauskaite R, Bausys A, Stadlbauer V, Jarmalaite S. Impact of mechanical bowel preparation on the gut microbiome of patients undergoing left-sided colorectal cancer surgery: randomized clinical trial. Br J Surg. 2024 Aug 30;111(9):znae213. doi: 10.1093/bjs/znae213.

Reference Type: DERIVED

PMID: 39222391 (View on PubMed)

Other Identifiers

BowelPrepMicrobiome

Identifier Type: -

Identifier Source: org_study_id