Colorectal (Colon or Rectal) CancerDoesn't existNCT07709923
Predictive Model For Anastomotic Leakage After Colorectal Cancer Surgery
An observational study of Colorectal (Colon or Rectal) Cancer and Leak, Anastomotic, run by University of Foggia at 1 site in Italy.
Trial summary
This pilot study aimed to develop a simplified early postoperative model for AL risk stratification using readily available clinical and laboratory variables. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Colorectal (Colon or Rectal) Cancer, Leak, Anastomotic, Surgery Complications
- How many people
- 117 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2024to 31 Dec 2025
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Colorectal cancer patients who developed an anastomotic fistula after surgery
Who may be able to join
- colorectal cancer resection
- construction of a primary anastomosis
- availability of clinical and laboratory data from the first postoperative day
Who cannot join
- staged procedures without primary anastomosis
- Hartmann's procedure
- protective stoma at the index operation
- incomplete data for the variables required for model construction.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Simplified Predictive Model For Anastomotic Leakage After Colorectal Cancer Surgery: A Pilot Retrospective Study
This pilot study aimed to develop a simplified early postoperative model for AL risk stratification using readily available clinical and laboratory variables.
Read the 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.
- Medical subject headings
- Colonic Neoplasms, Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients underwent elective colorectal surgery | number of leakage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (5)
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
Measured: 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.
Measured: 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.
Measured: 2 years
Brier Score of the Predictive Model
Calibration performance of the predictive model assessed using the Brier score.
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start1 Jan 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal (Colon or Rectal) CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 117 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- University of Foggia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanna Pavone, University of Foggia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07709923
- Sponsor's protocol ID
- 11
- Acronym
- Doesn't exist
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simplified Predictive Model For Anastomotic Leakage After Colorectal Cancer Surgery: A Pilot Retrospective Study
- ClinicalTrials.gov ID
- NCT07709923
- Acronym / sponsor ID
- Doesn't exist / 11
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- University of FoggiaUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 17 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients underwent elective colorectal surgery | – | –number of leakage |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Colorectal cancer patients who developed an anastomotic fistula after surgery
Key inclusion criteria (3 listed)
- colorectal cancer resection
- construction of a primary anastomosis
- availability of clinical and laboratory data from the first postoperative day
Key exclusion criteria (4 listed)
- staged procedures without primary anastomosis
- Hartmann's procedure
- protective stoma at the index operation
- incomplete data for the variables required for model construction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
Area Under the Receiver Operating Characteristic Curve (AUC-ROC) of the Predictive Model
Time frame: 2 years
Sensitivity of the Predictive Model for Clinically Significant Anastomotic Leakage
Time frame: 2 years
Specificity of the Predictive Model for Clinically Significant Anastomotic Leakage
Time frame: 2 years
Brier Score of the Predictive Model
Time frame: 2 yers
Hosmer-Lemeshow Goodness-of-Fit Test of the Predictive Model
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal (Colon or Rectal) Cancer and Leak, Anastomotic, run by University of Foggia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Developed Clinically Significant Anastomotic Leakage Requiring Surgical Reintervention and/or Stoma Creation (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.