Study of Brain-Gut Function Reconstruction After Intersphincteric Resection for Ultra-Low Rectal Tumors

Fudan University

Status: Enrolling

Conditions: Rectal Neoplasms

Treatments: Device: Transcranial magnetic stimulation; Device: Sham Transcranial magnetic stimulationt

Study type: Interventional

Funder types: Other

Identifiers

NCT06082648

KY2023-087

Details and patient eligibility

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.

Full 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 Hospital, Fudan University. Patients with ileostomy closure are randomly divided into two groups (TMS group and false stimulation group), and healthy volunteers were recruited. The differences of task-state fMRI between healthy volunteers, and ISR patients (both preoperative and postoperative) are compared, combined with rectal function scores (Wexner score, LARS score) and quality of life scale (EORTC QLQ-C30, EORTC QLQ-CR38). Proctoanal manometry are used to find the precise location of the proctoanal motor function area in the cerebral cortex, and to evaluate the effect and value of TMS on postoperative anorectal motor function remodeling in patients with ISR.

Enrollment: 57 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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57 participants in 3 patient groups

Sham Stimultion Group

Sham Comparator group

Description:

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:

Device: Sham Transcranial magnetic stimulationt

Pre-ileostomy-closure Stimultion Group

Active Comparator group

Description:

Patients on the Pre-ileostomy-closure group will be interfered with stimulation 3 weeks before the procedure of ileostomy closure.

Treatment:

Device: Transcranial magnetic stimulation

Post-ileostomy-closure Stimultion Group

Active Comparator group

Description:

Patients on the Post-ileostomy-closure group will be interfered with stimulation 3 weeks after the procedure of ileostomy closure.

Treatment:

Device: Transcranial magnetic stimulation