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
Qualifiers
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
Treatments tested in this trial
- Pre-op and post-op anorectal function and quality of life evaluation