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

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

NCT ID: NCT06082648

Condition: Rectal Neoplasms

Conditions: Official terms:
Rectal Neoplasms

Conditions: Keywords:
Ultra-low rectal tumors
Intersphincteric Resection
transcranial magnetic stimulation
fMRI

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Intervention:

Intervention type: Device
Intervention name: Transcranial magnetic stimulation
Description: 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.
Arm group label: Post-ileostomy-closure Stimultion Group
Arm group label: Pre-ileostomy-closure Stimultion Group

Intervention type: Device
Intervention name: Sham Transcranial magnetic stimulationt
Description: 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.
Arm group label: Sham Stimultion Group

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.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Huashan Hospital Affiliated to Fudan University

Address:
City: Shanghai
Zip: 200040
Country: China

Status: Recruiting

Contact:
Last name: Jianbin Xiang, doctor

Phone: 86-21-52887040
Email: 68875417@qq.com

Contact backup:
Last name: Minwei Zhou, doctor

Phone: 86-21-52887040
Email: zmwf1@126.com

Investigator:
Last name: Jianbin Xiang, doctor
Email: Principal Investigator

Start date: June 1, 2023

Completion date: October 30, 2026

Lead sponsor:
Agency: Huashan Hospital
Agency class: Other

Source: Huashan Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06082648