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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04013841

Enrollment

Registered

2019-07-10

Start date

2021-04-08

Completion date

2023-11-01

Last updated

2023-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

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.

Interventions

OTHEROral-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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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;

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Intestinal microbiome composition	30 days after surgery	Significant differences in the beta-diversity of the intestinal microbiome between oral and enema groups

Countries

Lithuania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026