Observation and Intervention Study of Brain-Gut Function Reconstruction After Intersphincteric Resection (ISR) for Ultra-Low Rectal Tumors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- The differences of cortical activated areas in task-state fMRI between health volunteers and postoperative ISR patients.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Sham Stimultion Group
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.
干预措施: Sham Transcranial magnetic stimulationt (Device)
Pre-ileostomy-closure Stimultion Group
Patients on the Pre-ileostomy-closure group will be interfered with stimulation 3 weeks before the procedure of ileostomy closure.
干预措施: Transcranial magnetic stimulation (Device)
Post-ileostomy-closure Stimultion Group
Patients on the Post-ileostomy-closure group will be interfered with stimulation 3 weeks after the procedure of ileostomy closure.
干预措施: Transcranial magnetic stimulation (Device)
结局指标
主要结局
The differences of cortical activated areas in task-state fMRI between health volunteers and postoperative ISR patients.
时间窗: 12 month after ileostomy closure。
Cortical activated areas in BOLD sequence of health volunteers and patients
Rectal function scores (Wexner score)
时间窗: pre-ISR，1, 3 , 6, 9, 12, 18, 24 month after ileostomy closure.
Wexner score of patients in different time frame
Quality of life Scale (EORTC QLQ-C30)
时间窗: pre-ISR，1, 3 , 6, 9, 12, 18, 24 month after ileostomy closure.
EORTC QLQ-C30 of patients in different time frame
Quality of life Scale (EORTC QLQ-CR38)
时间窗: 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)
时间窗: pre-ISR，1, 3 , 6, 9, 12, 18, 24 month after ileostomy closure.
LARS score of patients in different time frame
The differences of cortical activated areas in task-state fMRI in ISR patients.
时间窗: pre-ISR, pre-ileostomy closure, 6,12 month after ileostomy closure.
Cortical activated areas in BOLD sequence of patients in different time frame
次要结局
- Proctoanal manometry(pre-ISR，3 , 6, 12, 18, 24 month after ileostomy closure.)
研究者
Jianbin Xiang
Professor，Ph.D., M.D.
Huashan Hospital