Ultra-Low Rectal Tumors
Conditions
Interventions
Synchronous TMS Group:TMS intervention was initiated one week after the ostomy reversal surgery (when LARS symptoms were significantly present)
Shame TMS Group:Shame TMS intervention
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 - 75 years old 2. Meets the indications for ISR surgery: The lower edge of rectal adenocarcinoma is within 5 cm from the anal verge or less than 2 cm from the anal verge line; Tumor differentiation: moderate or high; Tumor stage (including after neoadjuvant therapy for tumor regression): If the tumor is above the levator ani hiatus, it should be in stage T3 or lower (not invading the puborectalis muscle); If the tumor is below the levator ani hiatus, it should be in stage T2 or lower. The circumferential resection margin should be negative. 3. Perform protective ileal stoma 4. Complete digestive tract reconstruction through manual anorectostomy or instrument-assisted anastomosis 5. Sign the informed consent form
Exclusion criteria
Exclusion criteria: 1. T4 stage tumors above the levator ani muscle hiatus and T3 stage tumors above the levator ani muscle hiatus 2. Presence of distant metastases or tumor recurrence 3. Poorly differentiated or undifferentiated carcinoma 4. Preoperative assessment of poor anal control function (WIS = 10 points) 5. Neurological and psychiatric disorders, such as Parkinson's disease, Alzheimer's disease, brain organic diseases, stroke, epilepsy history, major mental disorders (such as severe depression), etc. 6. Those who cannot accept or cooperate with TMS treatment 7. Inconclusive for fMRI scanning (e.g., history of metal implants in the body, claustrophobia, etc.) 8. Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rectal function scores (LARS score); | — |
Secondary
| Measure | Time frame |
|---|---|
| Rectal function scores (Wexner score);Quality of life Scale (EORTC QLQ-C30); Proctoanal manometry;The influence of the structure and morphology of the anal canal complex;Kirwan classification; | — |
Countries
China
Contacts
Public ContactJianbin Xiang
Huashan Hospital, Fudan University
Outcome results
None listed