About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Transcranial magnetic stimulation
DeviceThe magnetic stimulator equipment is provided by the MagProX100 magnetic stimulator ( MagVenture, Lucernemarken, DK-3520 Farum, Denmark), with 8-shaped coil, a maximum stimulation frequency of 30Hz and a maximum stimulation intensity of 6 Tesla.Stimulation group: Intermittentpulse transcranial magnetic stimulation (iTBS) will be performed with : the cluster consists of 3 pulses, the intra-cluster frequency is 50Hz, the intercluster frequency is 5Hz, the interval is 8.2s for every stimulus. There are 20 cycles and a total of 600 pulses. Each intervention time is 3min11s, and the stimulation intensity is set as 80% resting state motion threshold. The intervention will be performed once a day for 2 weeks.
Sham Transcranial magnetic stimulationt
DeviceThe magnetic stimulator equipment is provided by the MagProX100 magnetic stimulator ( MagVenture, Lucernemarken, DK-3520 Farum, Denmark), with 8-shaped coil, a maximum stimulation frequency of 30Hz and a maximum stimulation intensity of 6 Tesla. Patients on the Sham stimulation group will be interfered with the stimulation coil perpendicular to the skull, so that they will hear the sound of machine without having therapeutic effects. The parameters will be the same as those in the stimulation group.
Treatment groups
Trial outcomes
Primary outcomes
The differences of cortical activated areas in task-state fMRI in ISR patients.
Cortical activated areas in BOLD sequence of patients in different time frame
The differences of cortical activated areas in task-state fMRI between health volunteers and postoperative ISR patients.
Cortical activated areas in BOLD sequence of health volunteers and patients
Rectal function scores (Wexner score)
Wexner score of patients in different time frame
Rectal function scores (LARS score)
LARS score of patients in different time frame
Secondary outcomes
Proctoanal manometry
Proctoanal manometry of Patients in different time frame
Sponsors and contacts
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