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

NCT07189663 | Not Yet Recruiting DMC

• 2 other identifiers: 2025-study268-022019R68
• Study Type: observational
• Target: 1,468
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colorectal Neoplasia; Anastomotic Leakage

Keywords

colorectal neoplasia; anastomotic leakage; sialic acid

Outcome Measures

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

  From enrollment to the end of treatment at 1 month

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiaolong Li: lead

Study Sites (1)

Second Affiliated Hospital of Army Medical University

Chongqing, Chongqing Municipality, 400037, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Fecal samples (5-7g) were collected routinely for intestinal flora analysis (16SrRNA sequencing). Fecal samples were collected and stored immediately at-80 ° C for subsequent DNA extraction.(1) Fecal sialic acid testing: high performance liquid chromatography (HPLC) testing prospectively collected

MeSH Terms

Conditions

Anastomotic Leak

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Xiaolong Li, MD

CONTACT

+86 15025326575; 917304077@qq.com

Guangsheng DU, MD

CONTACT

+86 18716286196; guangsheng_du@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: September 24, 2025
• Study Start: September 25, 2025
• Primary Completion (Estimated): September 10, 2026
• Study Completion (Estimated): November 10, 2026
• Last Updated: September 24, 2025

Record last verified: 2025-09

Locations

CN (1)