Adenocarcinoma of the Rectum Clinical Trial
Official title:
Human Intestinal Microbiome and Surgical Outcomes in Patients Undergoing Colorectal Cancer Surgery
Intro: Recent studies on colorectal cancer surgery have been focusing on the role of
intestinal microbiome on surgical outcomes. Standard perioperative cares, like mechanic bowel
preparation (MBP), administration of antibiotics (ABT) and surgery-related stress and injury
influence the microbiome composition and possibly induce a shift toward a microbiome
dysbiotic state, which predisposes to complicated postoperative course. Microbiome
composition changes and enhanced virulence factors may increase the risk of postoperative
complications, such as anastomotic leakage (AL), surgical site infection (SSI), and
postoperative ileus (PI), which are known to impact on patient's overall survival and cancer
recurrence.
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.
n/a
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