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Completed

NCT Number: NCT07709923

Predictive Model For Anastomotic Leakage After Colorectal Cancer Surgery

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

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Key information

Conditions

Colorectal (Colon or Rectal) Cancer Anastomotic Leak Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Leak, Anastomotic Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgery Complications

Sex eligibility

All sexes

Study type

Observational

Primary location

Giovanna Pavone

Foggia, 71122, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 2 years

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

  2. Sensitivity of the Predictive Model for Clinically Significant Anastomotic Leakage

    Time frame: 2 years

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

  3. Specificity of the Predictive Model for Clinically Significant Anastomotic Leakage

    Time frame: 2 years

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

  4. Brier Score of the Predictive Model

    Time frame: 2 yers

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

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

    Time frame: 2 years

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

Sponsors and collaborators

Lead sponsor

University of Foggia

Other

Registry information

Official study title

Simplified Predictive Model For Anastomotic Leakage After Colorectal Cancer Surgery: A Pilot Retrospective Study

Acronym: Doesn't exist

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jul 17, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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