The Anorectal Function and QoL of Patients Receiving Transrectal NOSE Via Rigid TAMIS Platform in Minimal Invasive Colon Surgery

NCT07653607 | Not Yet Recruiting

• 1 other identifier: 202600564A3
• Study Type: interventional
• Target: 57
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Minimal Invasive Surgery; Colon Surgery

Outcome Measures

Primary Outcomes (1)

• The incidence of Internal Anal Sphincter (IAS) injury

  12 months post-surgery.

Secondary Outcomes (1)

• Change from baseline in Wexner score.

  12 months post surgery

Study Arms (1)

Patients receiving minimal invasive colon surgery with transrectal NOSE via rigid TAMIS platform

EXPERIMENTAL

Procedure: Pre-op and post-op anorectal function and quality of life evaluation

Interventions

Pre-op and post-op anorectal function and quality of life evaluation PROCEDURE

Pre-op and post-op anorectal function, rectal ultrasound and quality of life evaluation via questionaires

Patients receiving minimal invasive colon surgery with transrectal NOSE via rigid TAMIS platform

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• Concurrent participation in another interventional clinical trial that could potentially interfere with the study outcomes.
• Any other condition which, in the professional opinion of the investigator, makes the subject unsuitable for participation in this study.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2026
• First Posted: June 17, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2029
• Last Updated: June 17, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share