New study checks if 'No-Cut' colon surgery spares anal muscles
NCT ID NCT07653607
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
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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
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About 57 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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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.
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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.
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Other studies related to the condition(s) this trial covers.
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