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NCT Number: NCT07653607

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).
  • 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.

Treatment and study plan

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

Primary outcomes

  1. The incidence of Internal Anal Sphincter (IAS) injury

    Time frame: 12 months post-surgery.

Secondary outcomes

  1. Change from baseline in Wexner score.

    Time frame: 12 months post surgery

    The change from baseline in the total Wexner Incontinence Score (range 0-20) at each follow-up visit. A higher score means worse outcome.

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jun 17, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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