Predictive Model For Anastomotic Leakage After Colorectal Cancer Surgery

University of Foggia117 enrolled

Overview

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

This retrospective single-centre cohort included 117 patients who underwent colorectal cancer resection with primary anastomosis between January 2024 and December 2025. Patients with protective stomas or incomplete data were excluded. Demographic, clinical, surgical, and first-postoperative-day laboratory variables were analysed. Multivariable logistic regression was used to evaluate factors associated with AL and to assess model performance.

Study Type

OBSERVATIONAL

Enrollment

117

Conditions

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

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. colorectal cancer resection 2. construction of a primary anastomosis 3. availability of clinical and laboratory data from the first postoperative day Exclusion Criteria: 1. staged procedures without primary anastomosis 2. Hartmann's procedure 3. protective stoma at the index operation 4. incomplete data for the variables required for model construction.

Locations (1)

Giovanna Pavone

Foggia, Italy

Outcomes

Primary Outcomes

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.

Time frame: 2 years

Secondary Outcomes

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

Discriminative ability of the simplified logistic regression model for predicting clinically significant anastomotic leakage

Time frame: 2 years

Sensitivity of the Predictive Model for Clinically Significant Anastomotic Leakage

Sensitivity of the predictive model in identifying participants who developed clinically significant anastomotic leakage.

Time frame: 2 years

Specificity of the Predictive Model for Clinically Significant Anastomotic Leakage

Specificity of the predictive model in identifying participants who did not develop clinically significant anastomotic leakage.

Time frame: 2 years

Brier Score of the Predictive Model

Calibration performance of the predictive model assessed using the Brier score.

Time frame: 2 yers

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

Calibration performance of the predictive model assessed using the Hosmer-Lemeshow goodness-of-fit test.

Time frame: 2 years

Data from ClinicalTrials.gov

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