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New study checks if 'No-Cut' colon surgery spares anal muscles

NCT ID NCT07653607

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study will follow 57 people having minimally invasive colon surgery where the removed tissue is taken out through the rectum instead of a new abdominal cut. Researchers want to see how often this technique injures the internal anal sphincter muscle and how it affects bowel control and quality of life over 12 months. Participants will complete questionnaires and have anorectal function tests before and after surgery.

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 study could help surgeons understand how often this newer, less invasive surgery technique causes internal anal sphincter injury, potentially leading to better surgical choices.
What could go wrong
This is a small, early-stage observational study with no control group, so results may not apply broadly. It only measures outcomes, not treatment effectiveness.

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 57 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jul 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.

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: 1. Male or female, aged above 18 years, inclusive. 2. Patients scheduled for an elective laparoscopic or robotic-assisted colectomy above sigmoid colon. 3. Deemed a suitable candidate for the Transrectal NOSE procedure by the treating surgical team, based on tumor size (generally, largest diameter \< 4 cm), tumor T stage(1-3), location, and patient anatomy. 4. American Society of Anesthesiologists (ASA) physical status classification of I, II, or III. 5. Able to understand the purpose, procedures, potential risks, and benefits of the study and willing to provide written informed consent, as approved by the Institutional Review Board (IRB). 6. Willing and able to comply with all scheduled follow-up visits and assessment procedures outlined in the protocol. Exclusion Criteria: 1. Pre-existing moderate-to-severe fecal incontinence, defined as a Wexner incontinence score \> 8. 2. History of any prior anal surgery (e.g., sphincteroplasty, artificial sphincter implantation, fistulotomy), major pelvic surgery (e.g., hysterectomy, radical prostatectomy), or pelvic radiation therapy. 3. Confirmed diagnosis of Inflammatory Bowel Disease (Crohn's disease or ulcerative colitis). 4. The planned surgical procedure requires a protective stoma. 5. Uncorrectable coagulopathy identified on preoperative assessment. 6. Known neurological condition affecting bowel control (e.g., spinal cord injury, multiple sclerosis, significant post-stroke deficits). 7. Cognitive impairment, severe psychiatric illness, or other condition that would interfere with reliable completion of questionnaires or compliance with the protocol. 8. Currently pregnant, breastfeeding, or planning to become pregnant during the study period. 9. Concurrent participation in another interventional clinical trial that could potentially interfere with the study outcomes. 10. Any other condition which, in the professional opinion of the investigator, makes the subject unsuitable for participation in this study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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How to take part

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  1. The official record

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