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Clinical study of TCM external treatment combined with biofeedback to improve low anterior resection syndrome after rectal cancer

Clinical study of TCM external treatment combined with biofeedback to improve low anterior resection syndrome after rectal cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000749
Enrollment
Unknown
Registered
2024-11-27
Start date
2025-03-01
Completion date
Unknown
Last updated
2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal cancer

Interventions

Intervention group:The collaborative biofeedback intervention program of "moxibustion therapy + ear point pressure bean + acupuncture + percutaneous acupoint electrical stimulation" for patients after
Control group:Control group use the general nursing interventions.

Sponsors

Shanghai 10th People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Patients undergoing rectal cancer surgery in gastrointestinal Surgery Department and Colorectal Cancer Center of Shanghai 10th People's Hospital were selected. 1) Age: 18 years old with no gender limit; 2) Patients with pathological report results and intraoperative diagnosis of rectal cancer and laparoscopic or open rectal cancer surgery; 3) The subjects had good communication skills and were able to complete the questionnaire survey and intervention measures; 4) Voluntary signed written informed consent form.

Exclusion criteria

Exclusion criteria: 1) Subjects with previous inflammatory bowel disease constipation and irritable bowel syndrome that may affect bowel function; 2) Patients with a history of anorectal surgery pregnancy active infection or inflammation and active anal fissure 3) Patients with long-term use of drugs that may affect intestinal function and anal defecation function; 4) Patients with severe cardiovascular and cerebrovascular diseases or mental diseases that cannot cooperate; 5) Patients with serious postoperative complications such as anastomotic fistula; 6) Patients with short life expectancy (attending physician estimate <1 year) 7) Patients whose long-term residence is not in Shanghai and cannot come to the hospital to participate in the trial. 8) Patients refused to participate in the follow-up; 9) Any serious postoperative and non-postoperative related complications occurred during the study leading to readmission; 10) The study subjects have death tumor metastasis and recurrence;

Design outcomes

Primary

MeasureTime frame
Patient's pelvic floor electromyography score 12 months after surgery;Patient's Wexner Scale Score 3 Months After Surgery;Patient's Vaizey Scale Score 6 Months After Surgery;Patient's Wexner Scale Score 6 Months After Surgery;Patient's pelvic floor electromyography score 3 months after surgery;Patient's pelvic floor electromyography score 6 months after surgery;The incidence of LARS was observed at 12 months after surgery;The incidence of LARS was observed at 3 months after surgery;Patient's Vaizey Scale Score 3 Months After Surgery;Patient's Wexner Scale Score 12 Months After Surgery;The incidence of LARS was observed at 6 months after surgery;Patient's Vaizey Scale Score 12 Months After Surgery;

Secondary

MeasureTime frame
QLQ-C29 score at 3 months postoperatively;QLQ-C30 score at 6 months postoperatively;QLQ-C30 score at 3 months postoperatively;Hamilton Anxiety and Depression Scale at 12 months postoperatively;Complications within 30 days after surgery;Postoperative readmission rate of patients;QLQ-C29 score at 12 months postoperatively;QLQ-C30 score at 12 months postoperatively;Hamilton Anxiety and Depression Scale at 3 months postoperatively;Hamilton Anxiety and Depression Scale at 6 months postoperatively;QLQ-C29 score at 6 months postoperatively;

Countries

China

Contacts

Public Contactzhanglin

Shanghai 10th People's Hospital

13764430462@163.com+86 137 6443 0462

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026