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Colorectal NeoplasiaNCT07189663

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 of Colorectal Neoplasia and Anastomotic Leakage, run by Xiaolong Li at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Colorectal Neoplasia, Anastomotic Leakage
How many people
1,468 participants
Where
1 siteChina
Study dates
25 Sep 2025to 10 Nov 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

None listed.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xiaolong Li, MD contact

+86 15025326575

917304077@qq.com

China1 site
  • Second Affiliated Hospital of Army Medical University

    Chongqing, Chongqing Municipality, 400037

    Xiaolong Li, MD, +86 15025326575, 917304077@qq.com

    Yuhao Jiang, MD, +86 17384751418, 1935247339@qq.com

Other trials in China

About this study

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.

Keywords
colorectal neoplasia, anastomotic leakage, sialic acid
Medical subject headings
Anastomotic Leak

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07189663
Study groupRoleWhat they receive
Serum Sialic Acid (SA) High-Level GroupFor 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 GroupFor 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 GroupFor 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 GroupFor 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. The occurrence of anastomotic fistula

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

    Measured: From enrollment to the end of treatment at 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2025
  2. Study start25 Sep 2025 (estimated)
  3. Primary completion10 Sep 2026 (estimated)
  4. Study completion10 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Other
Enrolment
1,468 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07189663
Sponsor's protocol ID
2025-study268-02
Other IDs
2019R68
Status last verified
Sep 2025
First submitted
22 Sep 2025
Last updated
24 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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

Questions about this trial

What is this clinical trial studying?

An observational study of Colorectal Neoplasia and Anastomotic Leakage, run by Xiaolong Li at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xiaolong Li, MD (+86 15025326575, 917304077@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The occurrence of anastomotic fistula (time frame: From enrollment to the end of treatment at 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.

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