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New stitch could cut leak risk after colon surgery

NCT ID NCT07132970

Knowledge-focused Sponsor: Aesculap AG 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether a specific dissolvable stitch (Monoplus) can lower the chance of a leak where the bowel is reconnected after colon cancer surgery. About 249 people having either keyhole or open surgery will take part. The main goal is to see if the leak rate within 30 days is no worse than what is already reported in medical studies.

What this could mean

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

Active substance
Monoplus suture material (a type of dissolvable stitch)
What this could lead to
If successful, this could show that this stitch is a safe option for joining the bowel after colon cancer surgery, potentially reducing complications.
What could go wrong
This is a single-arm study comparing to historical data, not a head-to-head trial. The results may not prove superiority or generalise to all patients.

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 249 people

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

Started

Jan 2026

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

Patients undergoing elective, primary open or laparoscopic right hemicolectomy or right extended hemicolectomy for malignancy with the creation of an intracorporeal or extracorporeal ileo-colic anastomosis.

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: * Patients undergoing a primary, elective either open or laparoscopic right hemicolectomy or right extended hemicolectomy due to malignancy with the creation of an intracorporeal or extracorporeal ileo-colic anastomosis. * Either complete hand-sewn anastomosis or partial sutured anastomosis (e.g. combination of stapling and suturing) * Open or laparoscopic as well as conversion from open to laparoscopic surgery * Absence of peritoneal carcinomatosis * Absence of vascular, nervous or bone infiltration * Age ≥ 18 years * Written data protection declaration (Written Informed consent) Exclusion Criteria: * Left hemicolectomy or left extended hemicolectomy or sigma resection * Inflammatory bowel disease (e.g. Crohn´s disease) * Emergency surgery * Previous abdominal surgery with bowel resection * Re-operation of an anastomosis (anastomosis revision surgery) * Need for stoma creation * Non-compliant patients * Participation in an interventional randomized controlled study (RCT)

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Conditions

The condition(s) this trial relates to.

Anastomotic Leak ascending colon cancer colon carcinoma colonic neoplasm

As listed by the trial registrant

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

Anastomotic leak Colon cancer Right hemicolectomy

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

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

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • AGAPLESION ELISABETHENSTIFT, Klinik für Allgemein- und Viszeralchirurgie

    RECRUITING

    Darmstadt, 64287, Germany

  • Alb-Fils-Klinikum Göppingen, Dept. General Surgery

    RECRUITING

    Göppingen, Baden-Wurttemberg, 73035, Germany

  • Diakonie-Klinikum Landkreis Schwäbisch Hall, Dept. General Surgery

    RECRUITING

    Schwäbisch Hall, Baden-Wurttemberg, 74523, Germany

  • Städtisches Klinikum Lüneburg, Dept. General Surgery

    RECRUITING

    Lüneburg, Lower Saxony, 21339, Germany

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