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New Stitch-Free staple technique aims to cut leak risk in rectal cancer surgery

NCT ID NCT07376980

Disease control Sponsor: Korea University Anam Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This trial tests a modified stapling technique (MST) against the standard method in 450 adults having minimally invasive rectal cancer surgery. The goal is to see if MST reduces the chance of anastomotic leaks, a serious complication. Participants will be randomly assigned to one of the two techniques and monitored for leaks within 30 days after surgery.

What this could mean

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

Active substance
modified single-stapled anastomosis (a surgical technique)
What this could lead to
If successful, this new stapling method could lower the risk of dangerous leaks after rectal cancer surgery, leading to safer recovery.
What could go wrong
This is a surgical technique study, not a new drug. Results may show no significant benefit over the standard method, and individual surgeon skill can affect outcomes.

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 450 people

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

Started

Dec 2025

Expected to finish

Dec 2030

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

19 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: * Adult patients with rectal cancer who are scheduled to undergo laparoscopic or robotic low anterior resection * histologically confirmed rectal adenocarcinoma located within 15cm from anal verge. * ECOG performance status of 0 to 2 * Any clinical stage Exclusion Criteria: * Who have significant comorbidities or history of abdominal surgeries that would preclude a minimally invasive approach * Bowel obstruction for perforation requiring emergency surgey * Concurrent, or recent treatment for colorectal or other malignancies within the past five years * Presence of inflammatory bowel diseases * Hereditary colorectal cancer syndrome

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Conditions

The condition(s) this trial relates to.

Anastomotic Leak rectal cancer rectal neoplasm rectum adenocarcinoma

As listed by the trial registrant

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

Rectal cancer Rectal cancer surgery Rectal neoplasms Rectal neoplasms malignant

How to take part

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

  1. The places running it

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

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Korea University Anam Hospital

    Seoul, 02841, South Korea

  • Kyung Hee University Hospital

    Seoul, 02447, South Korea

  • Kyungpook National University Chilgok Hospital

    Daegu, Gyeongsangbuk-do, 41404, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital

    Seoul, 03722, South Korea

  • St. Vincent's Hospital

    Suwon, Gyeonggi-do, 16247, South Korea

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