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New model could spot dangerous surgical leaks before they happen

NCT ID NCT07709923

Knowledge-focused Sponsor: University of Foggia Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 17, 2026 · Last updated Jul 17, 2026

Summary

This study aims to create a simple model that uses routine clinical and lab data from the first day after colorectal cancer surgery to predict the risk of anastomotic leakage—a serious complication where the surgical connection leaks. Researchers reviewed records of 117 patients who had colorectal cancer surgery with a primary anastomosis. The goal is to help doctors identify high-risk patients early and potentially prevent severe outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this model could help surgeons identify patients at high risk of anastomotic leakage early, potentially reducing severe complications.
What could go wrong
This is a small, retrospective pilot study. The model needs validation in larger, prospective trials before it can be used in practice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

117 people

The number who actually took part.

Started

Jan 2024

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Colorectal cancer patients who developed an anastomotic fistula after surgery

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Anastomotic Leak colonic neoplasm colorectal cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colorectal (colon or rectal) cancer Leak, anastomotic Surgery--complications

Contacts and locations

Locations

  • Giovanna Pavone

    Foggia, 71122, Italy

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