Clinical trial NCT06082648: Study of Brain-Gut Function Reconstruction After Intersphincteric Resection for Ultra-Low Rectal Tumors
Official title: Observation and Intervention Study of Brain-Gut Function Reconstruction After Intersphincteric Resection (ISR) for Ultra-Low Rectal Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rectal Neoplasms
Keywords: Ultra-low rectal tumors
Intersphincteric Resection
transcranial magnetic stimulation
fMRI
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2023-10-13
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The differences of cortical activated areas in task-state fMRI in ISR patients.
timeFrame: pre-ISR, pre-ileostomy closure, 6,12 month after ileostomy closure.
measure: The differences of cortical activated areas in task-state fMRI between health volunteers and postoperative ISR patients.
timeFrame: 12 month after ileostomy closure。
measure: Rectal function scores (Wexner score)
timeFrame: pre-ISR，1, 3 , 6, 9, 12, 18, 24 month after ileostomy closure.
measure: Rectal function scores (LARS score)
timeFrame: pre-ISR，1, 3 , 6, 9, 12, 18, 24 month after ileostomy closure.
measure: Quality of life Scale (EORTC QLQ-C30)
timeFrame: pre-ISR，1, 3 , 6, 9, 12, 18, 24 month after ileostomy closure.
measure: Quality of life Scale (EORTC QLQ-CR38)
timeFrame: pre-ISR，1, 3 , 6, 9, 12, 18, 24 month after ileostomy closure.
Secondary outcomes:
measure: Proctoanal manometry
timeFrame: pre-ISR，3 , 6, 12, 18, 24 month after ileostomy closure.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital Affiliated to Fudan University
Study officials:
affiliation: Huashan Hospital
name: Jianbin Xiang, PhD
role: STUDY_CHAIR
References: