Study of Brain-Gut Function Reconstruction After Intersphincteric Resection for Ultra-Low Rectal Tumors
Recruiting · NCT06082648 · Interventional (participants receive a specific treatment) · Lead sponsor: Huashan Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Sham Transcranial magnetic stimulationtTranscranial magnetic stimulation
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
Exclusion criteria
- 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
1 location listed.
- Huashan Hospital Affiliated to Fudan University - Shanghai, China