Rectal Neoplasms
Conditions
Keywords
Ultra-low rectal tumors, Intersphincteric Resection, transcranial magnetic stimulation, fMRI
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 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
DEVICETranscranial 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 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.
DEVICESham 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 group.
Sponsors
Huashan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rectal function scores (Wexner score) | pre-ISR，1, 3 , 6, 9, 12, 18, 24 month after ileostomy closure. | Wexner score of patients in different time frame |
| The differences of cortical activated areas in task-state fMRI in ISR patients. | pre-ISR, pre-ileostomy closure, 6,12 month after ileostomy closure. | 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. | 12 month after ileostomy closure。 | Cortical activated areas in BOLD sequence of health volunteers and patients |
| Quality of life Scale (EORTC QLQ-CR38) | pre-ISR，1, 3 , 6, 9, 12, 18, 24 month after ileostomy closure. | EORTC QLQ-CR38 of patients in different time frame |
| Rectal function scores (LARS score) | pre-ISR，1, 3 , 6, 9, 12, 18, 24 month after ileostomy closure. | LARS score of patients in different time frame |
| Quality of life Scale (EORTC QLQ-C30) | pre-ISR，1, 3 , 6, 9, 12, 18, 24 month after ileostomy closure. | EORTC QLQ-C30 of patients in different time frame |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proctoanal manometry | pre-ISR，3 , 6, 12, 18, 24 month after ileostomy closure. | Proctoanal manometry of Patients in different time frame |
Countries
China
Contacts
Primary ContactYing Mao, PhD
Outcome results
None listed