Colorectal (Colon or Rectal) Cancer, Leak, Anastomotic, Surgery Complications
Conditions
Brief summary
This pilot study aimed to develop a simplified early postoperative model for AL risk stratification using readily available clinical and laboratory variables.
Detailed description
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.
Interventions
None listed
Sponsors
University of Foggia
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Developed Clinically Significant Anastomotic Leakage Requiring Surgical Reintervention and/or Stoma Creation | 2 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Receiver Operating Characteristic Curve (AUC-ROC) of the Predictive Model | 2 years | Discriminative ability of the simplified logistic regression model for predicting clinically significant anastomotic leakage |
| Sensitivity of the Predictive Model for Clinically Significant Anastomotic Leakage | 2 years | Sensitivity of the predictive model in identifying participants who developed clinically significant anastomotic leakage. |
| Specificity of the Predictive Model for Clinically Significant Anastomotic Leakage | 2 years | Specificity of the predictive model in identifying participants who did not develop clinically significant anastomotic leakage. |
| Brier Score of the Predictive Model | 2 yers | Calibration performance of the predictive model assessed using the Brier score. |
| Hosmer-Lemeshow Goodness-of-Fit Test of the Predictive Model | 2 years | Calibration performance of the predictive model assessed using the Hosmer-Lemeshow goodness-of-fit test. |
Countries
Italy
Outcome results
None listed