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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients underwent elective colorectal surgery | number of leakage |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 years |
| Sensitivity of the Predictive Model for Clinically Significant Anastomotic Leakage |
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Inclusion Criteria:
Exclusion Criteria:
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Colorectal cancer patients who developed an anastomotic fistula after surgery
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Giovanna Pavone | Foggia | 71122 | Italy |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: Revised file | May 15, 2026 | Jul 14, 2026 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D057868 | Anastomotic Leak |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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Sensitivity of the predictive model in identifying participants who developed clinically significant anastomotic leakage. |
| 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. | 2 years |
| Brier Score of the Predictive Model | Calibration performance of the predictive model assessed using the Brier score. | 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. | 2 years |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |