Minimal Invasive SurgeryNCT07653607
The Anorectal Function and QoL of Patients Receiving Transrectal NOSE Via Rigid TAMIS Platform in Minimal Invasive Colon Surgery
A study testing Pre-op and post-op anorectal function and quality of life evaluation in people with Minimal Invasive Surgery and Colon Surgery, run by Chang Gung Memorial Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Minimal Invasive Surgery, Colon Surgery
- What is being tested?
- Pre-op and post-op anorectal function and quality of life evaluation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 31 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
About this study
Official 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
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
- Being tested
- Pre-op and post-op anorectal function and quality of life evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-op and post-op anorectal function and quality of life evaluationProcedure or surgery
Pre-op and post-op anorectal function, rectal ultrasound and quality of life evaluation via questionaires
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving minimal invasive colon surgery with transrectal NOSE via rigid TAMIS platform | Experimental | Not described Receives: Procedure: Pre-op and post-op anorectal function and quality of life evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of Internal Anal Sphincter (IAS) injury
Measured: 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.
Measured: 12 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Minimal Invasive SurgeryStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07653607
- Sponsor's protocol ID
- 202600564A3
- Status last verified
- May 2026
- First submitted
- 24 May 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07653607
- Acronym / sponsor ID
- 202600564A3
- Conditions
- Minimal Invasive Surgery, Colon Surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-op and post-op anorectal function and quality of life evaluationPre-op and post-op anorectal function, rectal ultrasound and quality of life evaluation via questionaires | Procedure or surgery | Patients receiving minimal invasive colon surgery with transrectal NOSE via rigid TAMIS platform |
Primary outcome
The incidence of Internal Anal Sphincter (IAS) injury
Time frame: 12 months post-surgery.
1 secondary outcome
Change from baseline in Wexner score.
Time frame: 12 months post surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-op and post-op anorectal function and quality of life evaluation in people with Minimal Invasive Surgery and Colon Surgery, run by Chang Gung Memorial Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of Internal Anal Sphincter (IAS) injury (time frame: 12 months post-surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.