Status:
RECRUITING
Study of Brain-Gut Function Reconstruction After Intersphincteric Resection for Ultra-Low Rectal Tumors
Lead Sponsor:
Huashan Hospital
Conditions:
Rectal Neoplasms
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 regio...
Detailed Description
This study is a Single-center Phase II, Open, Three-Arm clinical trial. We prospectively enroll patients who undergo ISR for ultra-low rectal tumor in the department of General Surgery, Huashan Hospit...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2026
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT06082648
Start Date
June 1 2023
End Date
October 30 2026
Last Update
October 13 2023
Active Locations (1)
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1
Huashan Hospital Affiliated to Fudan University
Shanghai, China, 200040