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Not yet recruitingNCT07189663Updated Sep 24, 2025

Study on the Correlation Between Serum and Fecal Sialic Acid Levels and Tumor Characteristics as Well as Postoperative Anastomotic Leakage in Patients With Colorectal Tumors

An observational study in Colorectal Neoplasia and Anastomotic Leakage, sponsored by Xiaolong Li. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-09-24.

Sponsored by Xiaolong Li · Observational

Study type
Observational
Model
Case-control
Time perspective
Other
Enrollment
1,468
Ages
18 Years to 75 Years
Sex
All
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Study summary

This is a Single-center bidirectional cohort study combined with prospective sample analysis conducted by the Department of General Surgery at the Second Affiliated Hospital of Army Medical University (Xinqiao Hospital).

The purpose of this study was to retrospectively collect the preoperative serum sialic acid content and postoperative pathological data of colorectal cancer patients in our hospital's medical order system (including tumor size and stage, etc.) and anastomotic leakage, and analyze the correlation between serum sialic acid content and pathological characteristics of tumor and the correlation between anastomotic leakage; and further collect the feces of colorectal cancer patients in our hospital for 16S microbiome sequencing, and detect their sialic acid content, and observe the relationship between fecal sialic acid content and tumor size and stage; Intestinal flora composition and postoperative anastomotic leakage correlation, provide a new theoretical basis for the prevention and treatment of postoperative anastomotic malhealing.

Read the detailed description

Background#Colorectal cancer (CRC) is one of the most common gastrointestinal malignancies worldwide, ranking third in incidence and second in mortality among all cancers. Surgical resection remains the primary treatment for CRC, particularly for early- and mid-stage patients, as it effectively removes tumor tissue and prolongs survival. However, postoperative anastomotic healing failure (e.g., anastomotic leakage) is a severe complication of colorectal surgery, with an incidence rate of 5%-20%. Anastomotic leakage not only significantly increases postoperative mortality but also prolongs hospital stays, escalates medical costs, and imposes a heavy burden on both patients and healthcare systems. The pathogenesis of anastomotic leakage is complex,involving factors such as local ischemia, surgical technique, infection, and gut microbiota dysbiosis. In recent years, with advancements in microbiomics research, the role of gut microbiota in anastomotic healing has gained increasing attention.

During malignant transformation, colorectal cancer cells exhibit significantly upregulated expression of sialic acid (SA) on their cell surfaces. Sialic acid, a class of nine-carbon monosaccharides widely distributed on mammalian cell surfaces, participates in cell-cell recognition, immune regulation, and host-microbe interactions. Studies have shown that shed sialic acid from colorectal tumor cells enters the intestinal lumen, serving as a critical nutrient source for gut microbes. Notably, certain pathogens (e.g., Escherichia coli, Klebsiella pneumoniae) can utilize sialic acid as a carbon source to promote their proliferation and colonization. These pathogens may impair anastomotic healing through multiple mechanisms: first, by disrupting the intestinal mucosal barrier and exacerbating local inflammation; second, by inhibiting epithelial cell repair and delaying tissue regeneration; and third, by producing toxins or metabolites that further damage local tissues. Thus, colorectal tumor-derived sialic acid may indirectly increase the risk of postoperative anastomotic healing failure by nourishing specific pathogens. Although existing research suggests that sialic acid from colorectal tumors influences the gut microenvironment by feeding pathogens, the specific mechanisms underlying its impact on postoperative anastomotic healing remain unclear. This hypothesis requires experimental validation.

The purpose of this study was to retrospectively collect the preoperative serum sialic acid content and postoperative pathological data of colorectal cancer patients in our hospital's medical order system (including tumor size and stage, etc.) and anastomotic leakage, and analyze the correlation between serum sialic acid content and pathological characteristics of tumor and the correlation between anastomotic leakage; and further collect the feces of colorectal cancer patients in our hospital for 16S microbiome sequencing, and detect their sialic acid content, and observe the relationship between fecal sialic acid content and tumor size and stage; Intestinal flora composition and postoperative anastomotic leakage correlation, provide a new theoretical basis for the prevention and treatment of postoperative anastomotic malhealing.

Study Design# This study was carried out in the general surgery department of our hospital. Based on the hospital electronic medical record system (EMR), the data of patients meeting the standard from January 2010 to December 2020 were retrospectively extracted, and the stool samples and clinical data of patients scheduled for surgery from August 2025 to August 2026 were prospectively collected.

Primary Objective:Anastomotic fistula occurrence, changes in flora structure Key Outcomes# Data Analysis: Data extracted from electronic medical records. Statistical analysis using SPSS 22.0 (χ² test for categorical data, t-test for normally distributed continuous data; significance p\<0.05). Ethics: Approved by the institutional ethics committee. Conducted in accordance with the Declaration of Helsinki and Chinese regulations. Patient privacy and data confidentiality are prioritized. Timeline: Patient data collection and analysis (Aug 2025-Aug 2026); Statistical analysis and manuscript preparation (Sep-Dec 2025). Significance:The purpose of this study was to retrospectively collect the preoperative serum sialic acid content and postoperative pathological data of colorectal cancer patients in our hospital's medical order system (including tumor size and stage, etc.) and anastomotic leakage, and analyze the correlation between serum sialic acid content and pathological characteristics of tumor and the correlation between anastomotic leakage; and further collect the feces of colorectal cancer patients in our hospital for 16S microbiome sequencing, and detect their sialic acid content, and observe the relationship between fecal sialic acid content and tumor size and stage; Intestinal flora composition and postoperative anastomotic leakage correlation, provide a new theoretical basis for the prevention and treatment of postoperative anastomotic malhealing.

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Conditions studied

  • Colorectal Neoplasia
  • Anastomotic Leakage

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Keywords

  • colorectal neoplasia
  • anastomotic leakage
  • sialic acid
03

In context

Anastomotic Leak

209 studies on the registry are indexed under Anastomotic Leak; 60 are open to participants now.

This study's planned enrollment of 1,468 is above the median of 200 across 108 observational studies indexed under Anastomotic Leak.

Browse Anastomotic Leak studies →

Lead sponsor

Xiaolong Li is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients who underwent radical resection of colorectal cancer in the Department of General Surgery, Xinqiao Hospital

Eligibility criteria

Inclusion Criteria: For the retrospective Part : Age between 18 and 80 years; Patients who underwent radical resection of colorectal cancer in our hospital from January 2010 to December 2020; Preoperative serum sialic acid level was measured (a routine test item in liver function biochemical tests in our hospital from 2010 to 2020); Complete postoperative pathological data.

  • For the prospective Section:Age between 18 and 80 years; Patients who underwent radical resection of colorectal cancer in our hospital from August 2025 to August 2026; Voluntarily sign the informed consent form for fecal sample collection.

Exclusion Criteria:

  • Emergency surgery, palliative surgery, or concurrent other malignant tumors; Preoperative neoadjuvant chemoradiotherapy (may affect SA levels and microbiota); Recent infection: history of severe infection within 3 months before surgery.
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Study design

Observational model
Case-control
Time perspective
Other
Enrollment
1,468 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Serum Sialic Acid (SA) High-Level Group

    For the Retrospective Section , record the serum sialic acid (SA) levels of enrolled subjects. Using the median of these levels as the cutoff, assign patients with levels above the median to Serum Sialic Acid (SA) High-Level Group

  • Serum Sialic Acid (SA) Low-Level Group

    For the Retrospective Section , record the serum sialic acid (SA) levels of enrolled subjects. Using the median of these levels as the cutoff, assign patients with levels under the median to Serum Sialic Acid (SA) Low-Level Group

  • Fecal Sialic Acid (SA) High-Level Group

    For the prospective Section , record the fecal sialic acid (SA) levels of enrolled subjects. Using the median of these levels as the cutoff, assign patients with levels above the median to Fecal Sialic Acid (SA) High-Level Group

  • Fecal Sialic Acid (SA) Low-Level Group

    For thr prospective Section , record the fecal sialic acid (SA) levels of enrolled subjects. Using the median of these levels as the cutoff, assign patients with levels under the median to Fecal Sialic Acid (SA) Low-Level Group

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What researchers measure

Primary outcomes

  1. The occurrence of anastomotic fistula

    This study will statistically analyze the occurrence of anastomotic fistula in postoperative patients and explore its risk factors

    Time frame: From enrollment to the end of treatment at 1 month

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Study locations

1 site
  • Second Affiliated Hospital of Army Medical University
    Chongqing, Chongqing Municipality 400037, China
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References and documents

Individual participant data

Plan to share: Undecided — We are currently planning to conduct a series of studies. As data sharing will be postponed until all studies have been completed, the data will not be made available at this time

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07189663
Lead sponsor
Xiaolong Li
Responsible party
Xiaolong Li (Investigator, Army Medical University, China) — Sponsor-investigator
First posted
Sep 24, 2025
Start date
Sep 25, 2025 (estimated)
Primary completion
Sep 10, 2026 (estimated)
Completion
Nov 10, 2026 (estimated)
Last update
Sep 24, 2025

Study contacts

Xiaolong Li, MD
Contact
917304077@qq.com
+86 15025326575
Guangsheng DU, MD
Contact
guangsheng_du@hotmail.com
+86 18716286196

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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