An observational study in Colorectal (Colon or Rectal) Cancer, Leak, Anastomotic and Surgery Complications, sponsored by University of Foggia. Completed at 1 site in Italy. Per ClinicalTrials.gov, last updated 2026-07-17.
Sponsored by University of Foggia · Observational
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.
2,457 studies on the registry are indexed under Colonic Neoplasms; 458 are open to participants now.
This study's enrollment of 117 is below the median of 227 across 555 observational studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →University of Foggia is the lead sponsor of 36 studies on the registry; 4 are open to participants now.
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Colorectal cancer patients who developed an anastomotic fistula after surgery
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Exclusion Criteria:
number of leakage
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
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
Plan to share: No
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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University of Foggia