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

A Prospective, Multi-Center, Single-Arm, Open-Label Study to Analyze Anorectal Function and Quality of Life in Patients Undergoing Minimally Invasive Colectomy With Transrectal Natural Orifice Specimen Extraction (NOSE) Using a Rigid Transanal Minimally Invasive Surgery (TAMIS) Platform

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colon Surgery; Minimal Invasive Surgery
• Intervention / Treatment: Procedure: Pre-op and post-op anorectal function and quality of life evaluation

• Study Type: Interventional
• Enrollment (Estimated): 57
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients receiving minimal invasive colon surgery with transrectal NOSE via rigid TAMIS platform	Procedure: Pre-op and post-op anorectal function and quality of life evaluation; Pre-op and post-op anorectal function, rectal ultrasound and quality of life evaluation via questionaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The incidence of Internal Anal Sphincter (IAS) injury	12 months post-surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months post surgery

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2029

Study Registration Dates

• First Submitted: May 24, 2026
• First Submitted That Met QC Criteria: June 15, 2026
• First Posted (Actual): June 17, 2026

Study Record Updates

• Last Update Posted (Actual): June 17, 2026
• Last Update Submitted That Met QC Criteria: June 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 202600564A3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared due to strict restrictions imposed by our Institutional Review Board (IRB) and local data privacy regulations. These policies prohibit the external dissemination or public sharing of patient-level data to ensure the utmost protection of patient confidentiality and privacy. Only aggregated data will be shared through scientific publications.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No