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

Not Applicable

Completed

• Conditions: Colorectal Cancer
• Interventions: Other: Oral-agents/Enema

• Registration Number: NCT04013841
• Lead Sponsor: Vilnius University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-07
• Study First Submitted QC: 2019-07-07
• Study First Posted: 2019-07-10
• Study Start: 2021-04-08
• Primary Completion: 2022-08-01
• Status Verified: 2023-11
• Study Completion: 2023-11-01
• Last Update Submitted: 2023-11-07
• Last Update Posted: 2023-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral preparation	Oral-agents/Enema	The bowel preparation prior to colorectal resection will be conducted using oral-agents
Enema preparation	Oral-agents/Enema	The bowel preparation prior to colorectal resection will be conducted using rectal enema

Primary Outcome Measures

Name	Time	Method
Intestinal microbiome composition	6 days after surgery	Significant differences in the beta-diversity of the intestinal microbiome between oral and enema groups

Secondary Outcome Measures

Name	Time	Method
Intestinal microbiome composition	6 and 30 days after surgery	Significant differences in the alpha-diversity of the intestinal microbiome between oral and enema groups

Trial Locations

Locations (1)

National Cancer Institute; 🇱🇹 Vilnius, Lithuania