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study of biofeedback combined with percutaneous pudendal nerve stimulation in the treatment of low anterior rectal resection syndrome

study of biofeedback combined with percutaneous pudendal nerve stimulation in the treatment of low anterior rectal resection syndrome

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078101
Enrollment
Unknown
Registered
2023-11-28
Start date
2023-02-05
Completion date
Unknown
Last updated
2023-12-03

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

Conditions

Postoperative rehabilitation of rectal cancer

Interventions

Control Group: Biofeedback Therapy Group:Receiving biofeedback therapy once daily, five times a week, for a duration of 8 weeks.
Experimental Group: Biofeedback Combined with percutaneous pudendal Nerve Stimulation Treatment Group:Receiving percutaneous pudendal nerve electrical stimulation + biofeedback therapy once daily, fiv

Sponsors

Sir Run Run Shaw hospital, Zhejiang University school of medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1)Age between 18 and 80 years. 2)One month after laparoscopic-assisted radical rectal cancer surgery (including temporary ileostomy closure), patients still experience bowel dysfunction. 3)Meeting the diagnostic criteria for LARS as per the international LARS expert consensus. 4)Normal preoperative anal function with no bowel dysfunction. 5)Having good communication skills and the ability to cooperate with interventions and questionnaire surveys. 6)Voluntarily participating in this study, with the exclusion of vulnerable groups.

Exclusion criteria

Exclusion criteria: 1)Patients with a history of inflammatory bowel disease, constipation, irritable bowel syndrome, or other conditions that may affect bowel function. 2)Patients with permanent colostomies for reasons other than rectal cancer surgery. 3)Patients on long-term medication that may affect bowel function. 4)Patients with severe conditions affecting other organ systems, such as heart, liver, kidney, or nervous system diseases. 5)Patients with distant organ metastasis from tumors. 6)Vulnerable populations, including individuals with mental illness, cognitive impairment, critically ill patients, minors, and pregnant women.

Design outcomes

Primary

MeasureTime frame
LARS score;

Secondary

MeasureTime frame
anorectal manometry;EORTC QLQ-CR29 score;

Countries

China

Contacts

Public ContactGaoyang Cao

Sir Run Run Shaw hospital, Zhejiang University school of medicine

cgygift@zju.edu.cn+86 137 3220 7746

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026