Predictive Model For Anastomotic Leakage After Colorectal Cancer Surgery

NCT07709923 | Completed

• 1 other identifier: 11
• Study Type: observational
• Target: 117
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study aimed to develop a simplified early postoperative model for AL risk stratification using readily available clinical and laboratory variables.

Conditions

Colorectal (Colon or Rectal) Cancer; Leak, Anastomotic; Surgery Complications

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Developed Clinically Significant Anastomotic Leakage Requiring Surgical Reintervention and/or Stoma Creation

  Number of participants who developed clinically significant anastomotic leakage after colorectal cancer surgery. Anastomotic leakage was defined as an anastomotic defect confirmed by clinical, radiological, intraoperative, or postoperative findings requiring surgical reintervention and/or stoma creation.

  2 years

Secondary Outcomes (5)

• Area Under the Receiver Operating Characteristic Curve (AUC-ROC) of the Predictive Model

  2 years

• Sensitivity of the Predictive Model for Clinically Significant Anastomotic Leakage

  2 years

• Specificity of the Predictive Model for Clinically Significant Anastomotic Leakage

  2 years

• Brier Score of the Predictive Model

  2 yers

• Hosmer-Lemeshow Goodness-of-Fit Test of the Predictive Model

  2 years

Study Arms (1)

Patients underwent elective colorectal surgery

number of leakage

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Colorectal cancer patients who developed an anastomotic fistula after surgery

You may qualify if:

• colorectal cancer resection
• construction of a primary anastomosis
• availability of clinical and laboratory data from the first postoperative day

You may not qualify if:

• staged procedures without primary anastomosis
• Hartmann's procedure
• protective stoma at the index operation
• incomplete data for the variables required for model construction.

Sponsors & Collaborators

• University of Foggia: lead

Study Sites (1)

Giovanna Pavone

Foggia, 71122, Italy

Location

MeSH Terms

Conditions

Colonic Neoplasms; Anastomotic Leak

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: General Surgeon, MD

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 17, 2026
• Study Start: January 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)