Observation and Intervention Study of Brain-Gut Function Reconstruction After Intersphincteric Resection (ISR) for Ultra-Low Rectal Tumors
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: t
View:
• 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.
Locations
Other Locations
China
Huashan Hospital Affiliated to Fudan University
RECRUITING
Shanghai
Contact Information
Primary
Ying Mao, PhD
Maoying@huashan.cn
8621-52889999
Time Frame
Start Date: 2023-06-01
Estimated Completion Date: 2026-10-30
Participants
Target number of participants: 57
Treatments
Sham_comparator: Sham Stimultion Group
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.
Active_comparator: Pre-ileostomy-closure Stimultion Group
Patients on the Pre-ileostomy-closure group will be interfered with stimulation 3 weeks before the procedure of ileostomy closure.
Active_comparator: Post-ileostomy-closure Stimultion Group
Patients on the Post-ileostomy-closure group will be interfered with stimulation 3 weeks after the procedure of ileostomy closure.
Related Therapeutic Areas
Sponsors
Leads: Huashan Hospital