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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChang Gung Memorial Hospital

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 volunteers

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

Design model

Single group

Treatments tested in this trial

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

    Procedure/Surgery

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

Treatment groups

57 Participants
are divided into 1 treatment group
Group A: Patients receiving minimal invasive colon surgery with transrectal NOSE via rigid TAMIS platformExperimental treatment 1 intervention

Trial outcomes

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.

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

Time frame
12 months post surgery

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: