About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
The planned surgical procedure requires a protective stoma.
Trial design
Single group
Treatments tested in this trial
Pre-op and post-op anorectal function and quality of life evaluation
Procedure/SurgeryPre-op and post-op anorectal function, rectal ultrasound and quality of life evaluation via questionaires
Treatment groups
Trial outcomes
Primary outcomes
The incidence of Internal Anal Sphincter (IAS) injury
Secondary outcomes
Change from baseline in Wexner score.
The change from baseline in the total Wexner Incontinence Score (range 0-20) at each follow-up visit. A higher score means worse outcome.
Locations
Sponsors and contacts
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