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Can a powered stapler prevent leaks after colon surgery?

NCT ID NCT06578065

Disease control Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 09, 2026 · Last updated Sep 10, 2026 · Updated 1 time

Summary

This trial compares a new powered circular stapler with standard manual staplers in patients having colorectal surgery. The goal is to see if the powered device reduces anastomotic leakage, a serious complication where the reconnected bowel leaks. Researchers will randomly assign 540 adults to either the powered or manual stapler and follow them for 30 days to track leakage rates and other outcomes like bleeding and overall complications.

What this could mean

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

Active substance
Echelon Circular Powered Stapler
What this could lead to
If the powered stapler works better, it could become a preferred tool for colorectal surgery, helping more patients avoid serious complications like leaks.
What could go wrong
The trial may show no difference between the two staplers, or the powered device might not perform as well in real-world settings. As with any surgery, there are risks of infection, bleeding, and other complications.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 540 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2024

Expected to finish

Sep 2027

An estimate. End dates often move.

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Patient or its legal representative informed consent. * Age ≥ 18 years. * Patients who will undergo a colorectal anastomosis after left colectomy, sigmoidectomy or anterior rectal resection, for benign or malignant pathology (NOTE: Hartmann reversal cases also included). Exclusion Criteria: * Diverting stoma. * Emergency surgery. * American Society of Anaesthesiologists (ASA) score ≥ IV. * Transanal total mesorectal excision approach.

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As listed by the trial registrant

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

Colorectal anastomosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Consorci Corporació Sanitària Parc Taulí de Sabadell

    NOT_YET_RECRUITING

    Sabadell, Barcelona, 08208, Spain

  • Hospital Clínico Universitario Virgen de la Arrixaca

    RECRUITING

    Murcia, 30120, Spain

  • Hospital Clínico Universitario de Valencia

    RECRUITING

    Valencia, 46010, Spain

  • Hospital General Universitario Gregorio Marañón

    RECRUITING

    Madrid, 28007, Spain

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