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New stapling technique aims to cut colon surgery leaks

NCT ID NCT07417358

Knowledge-focused Sponsor: Umeå University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at a new way to reconnect the colon after surgery for cancer or diverticular disease. The goal is to see if using a single stapler instead of two can lower the risk of dangerous leaks at the connection point. About 500 adults having planned left-sided colon surgery will be observed, and their results will be compared to past patients who had the standard two-stapler method.

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

About 500 people

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

Started

Jan 2026

Expected to finish

Jun 2029

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.

Who is studied

The study population consists of adult patients (≥18 years) undergoing planned left-sided colorectal resection with construction of a colorectal anastomosis, including left hemicolectomy, sigmoid resection, or partial mesorectal excision, for benign or malignant indications. Patients are treated as part of routine clinical care at participating centers. The study includes both a retrospective cohort of patients operated during 2023-2025 and a prospective cohort of consecutively included patients undergoing surgery after study initiation. In the prospective cohort, the intent is to perform a single-stapled colorectal anastomosis when technically feasible in all consenting patients.

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: * Age ≥ 18 years. * Planned (elective) left-sided colorectal resection with creation of a colorectal anastomosis, including: Left hemicolectomy, and/or Sigmoid resection, and/or Partial mesorectal excision (PME). * Benign or malignant indication. * Prospective cohort: Ability to provide written informed consent. * Retrospective cohort: Eligible patients operated during 2023-2025 at participating centers, identified through medical record review, meeting the same surgical inclusion criteria. Exclusion Criteria: * Total mesorectal excision (TME) (e.g., low rectal cancer surgery requiring TME). * Non-left-sided colorectal resections (e.g., right-sided colectomy) or procedures outside the study-defined operations. * Surgery not involving a colorectal anastomosis (e.g., end colostomy/Hartmann's procedure without anastomosis). * Emergency/urgent colorectal resection (non-elective surgery). * Prospective cohort: Inability to provide informed consent.

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Conditions

The condition(s) this trial relates to.

Anastomotic Leak colorectal cancer colorectal neoplasm

As listed by the trial registrant

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

Anastomotic leakage Colorectal anastomosis Colorectal cancer Diverticular disease of left side of colon

How to take part

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

  1. The places running it

    5 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

  • Skåne University Hospital

    RECRUITING

    Malmö, Sweden

  • Sunderby Hospital

    RECRUITING

    Luleå, Sweden

  • Surgical Centre, Umeå University Hospital

    RECRUITING

    Umeå, Sweden

  • Uppsala University Hospital

    RECRUITING

    Uppsala, Sweden

  • Östra Sahlgrenska University Hospital

    RECRUITING

    Gothenburg, Sweden

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