Study of Brain-Gut Function Reconstruction After Intersphincteric Resection for Ultra-Low Rectal Tumors
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Rectal Neoplasms
In brief
To investigate the effects of intersphincteric resection (ISR) of ultra-low rectal tumor on the brain-rectoanal function of patients, and to precisely localize the cerebral functional regulatory regions for intervention targets of anorectal remodeling. Utilizing transcranial magnetic stimulation(TMS) technology to explore the functional remodeling of the "new" anorectal muscle groups and provide a theoretical basis for more research on the rehabilitation and mechanism of fecal incontinence.
Key facts
- Study ID
- NCT06082648
- Run by
- Huashan Hospital
- People needed
- 57
- Starts
- 2023-06-01
- Expected to finish
- 2026-10-30
- Last updated by the study team
- 2023-10-13
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Primary ultra-low rectal tumor patient who is received intersphincteric resection and preventive ileostomy was performed.
- Patient who is willing to participate in the study, and voluntarily sign informed consent.
You may not qualify if…
- Anastomotic leakage or other serious complications occur after surgery.
- Advanced tumor, tumor recurrence or metastasis.
- Patients with contraindications of fMRI scanning, such as history of metal implants in the body, claustrophobia, etc.
- Patients with contraindications for TMS treatment, such as intracranial metal implants, epilepsy history, heart disease with unstable heart function, retinal detachment, etc.
- Combined with organic brain disease and drug abuse history.
- Combined with other mental diseases.
- Pregnant or lactating women.
Where it is running
- Huashan Hospital Affiliated to Fudan University — Shanghai, China (enrolling)
Full record on ClinicalTrials.gov
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