Clinical trial · Observational
Human Intestinal Microbiome and Surgical Outcomes in Patients Undergoing Colorectal Cancer Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of the Colon | Colon Adenocarcinoma | ALIAS | 0.90 |
| Adenocarcinoma of the Rectum | Rectal Adenocarcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- preoperative preparation on microbiome composition
- description
- 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.
Primary outcomes (3)
- measure
- Rate of anastomotic leakage
- timeFrame
- 90 days after surgery
- description
- detected by imaging techiques (CT scan or MRI)
- measure
- Rate of surgical site infection
- timeFrame
- 90 days after surgery
- description
- 1)superficial and deep infection:clinical observation of purulent discharge from the wound and/or bacterial staining from the wound 2)organ or deep space infection: imaging techniques (CT, MRI, USS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult ≥ 18 years old * 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: * Major surgery 30 days before scheduled colorectal surgery * 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
References
Publications (0)
Data not yet available