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

September 22, 2025 updated by: Xiaolong Li

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.

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

1468

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400037
        • Second Affiliated Hospital of Army Medical University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The occurrence of anastomotic fistula
Time Frame: From enrollment to the end of treatment at 1 month
This study will statistically analyze the occurrence of anastomotic fistula in postoperative patients and explore its risk factors
From enrollment to the end of treatment at 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiaolong Li

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 25, 2025

Primary Completion (Estimated)

September 10, 2026

Study Completion (Estimated)

November 10, 2026

Study Registration Dates

First Submitted

September 22, 2025

First Submitted That Met QC Criteria

September 22, 2025

First Posted (Estimated)

September 24, 2025

Study Record Updates

Last Update Posted (Estimated)

September 24, 2025

Last Update Submitted That Met QC Criteria

September 22, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-study268-02
  • 2019R68 (Other Grant/Funding Number: ArmyMedChina)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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