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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHuashan Hospital

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Transcranial magnetic stimulation

    Device

    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.

  • Sham Transcranial magnetic stimulationt

    Device

    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.

Treatment groups

57 Participants
are divided into 3 treatment groups
Group A: Sham Stimultion GroupSham comparator 1 intervention
Group B: Pre-ileostomy-closure Stimultion GroupActive comparator 1 intervention
Group C: Post-ileostomy-closure Stimultion GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

The differences of cortical activated areas in task-state fMRI in ISR patients.

Cortical activated areas in BOLD sequence of patients in different time frame

Time frame
pre-ISR, pre-ileostomy closure, 6,12 month after ileostomy closure.
2

The differences of cortical activated areas in task-state fMRI between health volunteers and postoperative ISR patients.

Cortical activated areas in BOLD sequence of health volunteers and patients

Time frame
12 month after ileostomy closure。
3

Rectal function scores (Wexner score)

Wexner score of patients in different time frame

Time frame
pre-ISR,1, 3 , 6, 9, 12, 18, 24 month after ileostomy closure.
4

Rectal function scores (LARS score)

LARS score of patients in different time frame

Time frame
pre-ISR,1, 3 , 6, 9, 12, 18, 24 month after ileostomy closure.

Secondary outcomes

1

Proctoanal manometry

Proctoanal manometry of Patients in different time frame

Time frame
pre-ISR,3 , 6, 12, 18, 24 month after ileostomy closure.

Other outcomes

Sponsors and contacts

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