NCT04013841

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for not_applicable colorectal-cancer

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 10, 2019

Completed
1.7 years until next milestone

Study Start

First participant enrolled

April 8, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

November 8, 2023

Status Verified

November 1, 2023

Enrollment Period

1.3 years

First QC Date

July 7, 2019

Last Update Submit

November 7, 2023

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • Intestinal microbiome composition

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

    6 days after surgery

Secondary Outcomes (2)

  • Intestinal microbiome composition

    30 days after surgery

  • Intestinal microbiome composition

    6 and 30 days after surgery

Study Arms (2)

Oral preparation

EXPERIMENTAL

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

Other: Oral-agents/Enema

Enema preparation

EXPERIMENTAL

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

Other: Oral-agents/Enema

Interventions

Oral-agents/EnemaOTHER

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 preparationOral preparation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 y.;
  • Signed informed consent;
  • Left-side colorectal resection for colorectal cancer;

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Institute

Vilnius, Lithuania

Location

Related Publications (2)

  • 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.

    PMID: 40596170DERIVED

  • 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.

    PMID: 39222391DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Enema

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

July 7, 2019

First Posted

July 10, 2019

Study Start

April 8, 2021

Primary Completion

August 1, 2022

Study Completion

November 1, 2023

Last Updated

November 8, 2023

Record last verified: 2023-11

Locations

LI(1)