Colorectal cancer
Conditions
Interventions
Synchronous TMS Group:TMS intervention was initiated one week after the ostomy reversal surgery (when LARS symptoms were significantly present)
Control 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 range: 18 to 75 years old; 2.Meeting the indications for ISR surgery: the lower edge of the rectal adenocarcinoma is within 5 cm from the anal verge or less than 2 cm from the dentate line; the degree of tumor differentiation: moderately or highly differentiated; tumor stage (including after neoadjuvant therapy downstaging): for tumors located above the levator ani hiatus, it should be within T3 stage (without invasion of the puborectalis muscle), and for those below the levator ani hiatus, it should be within T2 stage, with a negative circumferential resection margin required; 3.Protective ileostomy; 4.Completion of digestive tract reconstruction by manual or instrument-assisted anastomosis between the colon and the anus; 5.Informed consent signed;
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 Wexner Incontinence Score (WIS) >=10; 5.neurological or psychiatric disorders (including Parkinson’s disease, Alzheimer’s disease, stroke, history of epilepsy, and other mental disorders); contraindications to TMS; contraindications to functional magnetic resonance imaging (fMRI, e.g., metallic implants, claustrophobia); 6.those who cannot accept or cooperate with TMS treatment; 7.patients with contraindications for fMRI scanning (such as history of internal metal implants, claustrophobia, etc.); 8.pregnancy/lactation;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| LARS score; | — |
Secondary
| Measure | Time frame |
|---|---|
| The influence of the structure and morphology of the anal canal complex;Wexner Incontinence Score;Kirwan classification;Defecation control function of the rectum;Postoperative quality of life; | — |
Countries
China
Contacts
Public ContactXiang Jianbin
Huashan Hospital, Fudan University
Outcome results
None listed