Human Intestinal Microbiome and Surgical Outcomes in Patients Undergoing Colorectal Cancer Surgery
NCT ID: NCT04005118
Last Updated: 2019-07-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
50 participants
OBSERVATIONAL
2019-05-28
2020-04-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Objective: The primary objective is to investigate if a significant association might exist between the microbiome composition and the occurrence of postoperative complications at 90 days.
Methods: 3 different microbiome samples will be taken from all patients. Two fresh fecal samples for detection of LM and fecal water preparation: a) a day before the surgery before MBP and/or ABT (LM1), b) postoperatively after first bowel movement (LM2). One sample will be taken intra-operatively from the stapled resection lines of circular stapler used for forming a colorectal anastomosis, to detect the MAM and to perform immunohistochemistry staining for detection of HACE1 expression.
DNA analysis will be performed for all samples. IHC will be performed for detecting HACE1 expression in the tumor and colorectal anastomosis tissues using anti-HACE1 antibodies. .
For proliferation assessment, human colon carcinoma cell lines HT29 will be plated in monolayers and scratched with a single scratch. Monolayers will be incubated for 24 hours with fecal water from patients with surgical complications and matched control patients without complications.
Descriptive statistics will be performed to describe the study population. This project aim to describe microbiome composition and its impact on postoperative complications.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Gut Microbiota, Anastomotic Leak and Colorectal Cancer
NCT04071964
Gut Microbiome in Colorectal Cancer
NCT04054908
Microbiome and Colorectal Cancer Recurrence
NCT07057076
Study of Gut Microbiome and Colorectal Tumors
NCT03297996
Early Detection of Treatment Failure in Metastatic Colorectal Cancer Patients
NCT05068531
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
preoperative preparation on microbiome composition
Mechanical Bowel Preparation + oral antibiotics group: receiving mechanical bowel preparation only MBP will be prepared with 4 liters of Polyethylene glycol (PEG) solution to be started 24 hours before the planned surgery. 500mg of Metronidazole will be administrated 3 times one day before the surgery at 2 pm, 3 pm and 10 pm.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* With histologically confirmed rectal or left colon adenocarcinoma by biopsy material from colonoscopy
* Having elective colorectal surgery after standardized bowel preparation
* Affiliated to a social security system
* Signature of informed consent
Exclusion Criteria
* Administration of systemic antibiotic therapy within 30 days prior to planned colorectal surgery
* Presenting a contraindication to elective colorectal surgery
* Patient protected by law
* Pregnant or breastfeeding woman
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Lelde Lauka, PHD
Role: PRINCIPAL_INVESTIGATOR
APHP
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Dr Lelde Lauka
Créteil, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Lauka Lelde, PhD
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
APHP190088
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.