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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients receiving minimal invasive colon surgery with transrectal NOSE via rigid TAMIS platform | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of Internal Anal Sphincter (IAS) injury | 12 months post-surgery. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 14, 2026 | Jun 14, 2026 |
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| Prot_000.pdf |