Study of Brain-Gut Function Reconstruction After Intersphincteric Resection for Ultra-Low Rectal Tumors
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transcranial magnetic stimulation, Sham Transcranial magnetic stimulationt.
- Who it may be relevant to
- Registry conditions: Rectal Neoplasms. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Observation and Intervention Study of Brain-Gut Function Reconstruction After Intersphincteric Resection (ISR) for Ultra-Low Rectal Tumors
Overview
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.
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 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.
Interventions
- Device Transcranial magnetic stimulation
The 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 - Device Sham Transcranial magnetic stimulationt
The 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 gr
Primary outcome measures
- The differences of cortical activated areas in task-state fMRI in ISR patients. [Time frame: pre-ISR, pre-ileostomy closure, 6,12 month after ileostomy closure.]
- The differences of cortical activated areas in task-state fMRI between health volunteers and postoperative ISR patients. [Time frame: 12 month after ileostomy closure。]
- Rectal function scores (Wexner score) [Time frame: pre-ISR，1, 3 , 6, 9, 12, 18, 24 month after ileostomy closure.]
- Rectal function scores (LARS score) [Time frame: pre-ISR，1, 3 , 6, 9, 12, 18, 24 month after ileostomy closure.]
- Quality of life Scale (EORTC QLQ-C30) [Time frame: pre-ISR，1, 3 , 6, 9, 12, 18, 24 month after ileostomy closure.]
- Quality of life Scale (EORTC QLQ-CR38) [Time frame: pre-ISR，1, 3 , 6, 9, 12, 18, 24 month after ileostomy closure.]
Secondary outcome measures (1)
- Proctoanal manometry [Time frame: pre-ISR，3 , 6, 12, 18, 24 month after ileostomy closure.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Huashan Hospital Affiliated to Fudan University — Shanghai
Identifiers
NCT: NCT06082648 · KY2023-087