Colorectal CancerNCT04013841
Bowel Preparation Impact on the Intestinal Microbiome: Oral Preparation vs Enema
A study testing Oral-agents/Enema in people with Colorectal Cancer, run by Vilnius University at 1 site in Lithuania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Oral-agents/Enema
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteLithuania
- Study dates
- 8 Apr 2021to 1 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 y.;
- Signed informed consent;
- Left-side colorectal resection for colorectal cancer;
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bowel Preparation for Left Side Colon Surgery Impact on the Intestinal Microbiome: Oral Preparation vs Enema
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
- Being tested
- Oral-agents/Enema
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral-agents/EnemaOther
- Oral-agents for mechanical bowel preparation prior to left-side colorectal resection
- Enema for mechanical bowel preparation prior to left-side colorectal resection
| Study group | Role | What they receive |
|---|---|---|
| Oral preparation | Experimental | The bowel preparation prior to colorectal resection will be conducted using oral-agents Receives: Other: Oral-agents/Enema |
| Enema preparation | Experimental | The bowel preparation prior to colorectal resection will be conducted using rectal enema Receives: Other: Oral-agents/Enema |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intestinal microbiome composition
Significant differences in the beta-diversity of the intestinal microbiome between oral and enema groups
Measured: 6 days after surgery
Secondary outcomes (2)
Intestinal microbiome composition
Significant differences in the beta-diversity of the intestinal microbiome between oral and enema groups
Measured: 30 days after surgery
Intestinal microbiome composition
Significant differences in the alpha-diversity of the intestinal microbiome between oral and enema groups
Measured: 6 and 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start8 Apr 2021
- Primary completion1 Aug 2022
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vilnius University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Rimantas Bausys, Vilnius University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04013841
- Sponsor's protocol ID
- BowelPrepMicrobiome
- Status last verified
- Nov 2023
- First submitted
- 7 Jul 2019
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40596170Zukauskaite 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.
PubMed 39222391
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bowel Preparation for Left Side Colon Surgery Impact on the Intestinal Microbiome: Oral Preparation vs Enema
- ClinicalTrials.gov ID
- NCT04013841
- Acronym / sponsor ID
- BowelPrepMicrobiome
- Conditions
- Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Vilnius UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 8 Apr 2021 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 10 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral preparation | Experimental | Other: Oral-agents/EnemaThe bowel preparation prior to colorectal resection will be conducted using oral-agents |
| Enema preparation | Experimental | Other: Oral-agents/EnemaThe bowel preparation prior to colorectal resection will be conducted using rectal enema |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 y.;
- Signed informed consent;
- Left-side colorectal resection for colorectal cancer;
Key exclusion criteria (8 listed)
- Anticipated ileostoma;
- Allergy to oral preparation agents;
- Multivisceral surgery;
- Emergency surgery;
- History of inflammatory bowel disease;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral-agents/Enema1. Oral-agents for mechanical bowel preparation prior to left-side colorectal resection 2. Enema for mechanical bowel preparation prior to left-side colorectal resection | Other | Enema preparation, Oral preparation |
Primary outcome
Intestinal microbiome composition
Time frame: 6 days after surgery
Significant differences in the beta-diversity of the intestinal microbiome between oral and enema groups
2 secondary outcomes
Intestinal microbiome composition
Time frame: 30 days after surgery
Intestinal microbiome composition
Time frame: 6 and 30 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- Derived from this study: PubMed 40596170Rauduvyte 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.
- Derived from this study: PubMed 39222391Zukauskaite 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral-agents/Enema in people with Colorectal Cancer, run by Vilnius University at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intestinal microbiome composition (time frame: 6 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04013841, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2023.