Investigating brain-gut function after surgery for ultra-low rectal tumors
Observation and Intervention Study of Brain-Gut Function Reconstruction After Intersphincteric Resection (ISR) for Ultra-Low Rectal Tumors
This study is testing how surgery for ultra-low rectal tumors affects the way the brain and rectum work together, to see if brain stimulation can help improve bowel control afterwards.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 57 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Huashan Hospital Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06082648 on ClinicalTrials.gov |
What this trial studies
This study examines how intersphincteric resection (ISR) for ultra-low rectal tumors affects brain-rectoanal function. It involves enrolling patients who have undergone ISR and comparing their brain activity and rectal function scores before and after surgery using advanced imaging techniques like fMRI and transcranial magnetic stimulation (TMS). The goal is to identify brain regions that regulate anorectal function and assess the potential for TMS to aid in rehabilitation and improve outcomes for patients experiencing fecal incontinence post-surgery.
Who should consider this trial
Good fit: Ideal candidates are patients with primary ultra-low rectal tumors who have undergone intersphincteric resection and preventive ileostomy.
Not a fit: Patients with serious postoperative complications, advanced tumors, or contraindications for fMRI or TMS will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved rehabilitation strategies for patients suffering from fecal incontinence after rectal surgery.
How similar studies have performed: While the specific combination of ISR and TMS is novel, similar studies exploring brain-gut interactions and rehabilitation techniques have shown promise.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shanghai
- Huashan Hospital Affiliated to Fudan University — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Ying Mao, PhD
- Email: Maoying@huashan.cn
- Phone: 8621-52889999
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.