The Anorectal Function and QoL of Patients Receiving Transrectal NOSE Via Rigid TAMIS Platform in… (NCT07653607) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Anorectal Function and QoL of Patients Receiving Transrectal NOSE Via Rigid TAMIS Platform in Minimal Invasive Colon Surgery
57 participantsStarted 2026-06-01
Plain-language summary
The primary objective of this study is to prospectively determine and precisely estimate the incidence of Internal Anal Sphincter (IAS) Injury at 12 months following colectomy with Transrectal NOSE.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female, aged above 18 years, inclusive.
. Patients scheduled for an elective laparoscopic or robotic-assisted colectomy above sigmoid colon.
. 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.
. American Society of Anesthesiologists (ASA) physical status classification of I, II, or III.
. 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).
. Willing and able to comply with all scheduled follow-up visits and assessment procedures outlined in the protocol.
Exclusion criteria
. Pre-existing moderate-to-severe fecal incontinence, defined as a Wexner incontinence score \> 8.
. 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.
. Confirmed diagnosis of Inflammatory Bowel Disease (Crohn's disease or ulcerative colitis).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is specifically looking at whether a rigid TAMIS platform used during transrectal NOSE surgery causes injury to the internal anal sphincter — how concerned should I personally be about that risk given my anatomy or any pre-existing bowel function issues?
2Since this trial hasn't started recruiting yet, how long might it be before it opens, and is there a standard minimally invasive colon surgery approach I should consider in the meantime?
3The study is listed as Phase NA, which suggests it's more of an observational or procedural study rather than a drug trial — can you help me understand what that means for how much safety and outcome data already exists for this specific TAMIS platform approach?
4If internal anal sphincter injury does occur during a transrectal NOSE procedure, what would that mean for my long-term bowel control and quality of life, and how does that risk compare to a more conventional laparoscopic colon surgery that doesn't use a natural orifice extraction?
5This trial is measuring anorectal function and quality of life as outcomes — are there validated ways my anorectal function would be tested before and after surgery, and would I need to commit to follow-up assessments as part of participating?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The incidence of Internal Anal Sphincter (IAS) injury
. The planned surgical procedure requires a protective stoma.
. Uncorrectable coagulopathy identified on preoperative assessment.
. Known neurological condition affecting bowel control (e.g., spinal cord injury, multiple sclerosis, significant post-stroke deficits).
. Cognitive impairment, severe psychiatric illness, or other condition that would interfere with reliable completion of questionnaires or compliance with the protocol.
. Currently pregnant, breastfeeding, or planning to become pregnant during the study period.