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Clinical study on combination therapy of Functional Defecation Disorders based on accurate imaging assessment

Clinical study on combination therapy of Functional Defecation Disorders based on accurate imaging assessment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036547
Enrollment
Unknown
Registered
2020-08-24
Start date
2021-01-01
Completion date
Unknown
Last updated
2020-09-14

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

Conditions

Functional defecation disorders

Interventions

pelvic floor dyssynergic:biofeedback and Acupuncture treatment
rectocele:biofeedback and operation
pelvic floor dyssynergic+ rectocele:biofeedback and Acupuncture treatment+ operation

Sponsors

Longhua Hospital Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosed with ODS by defecography, coloscopy, barium enema and dynamic MRI. 2. Patients should accord with Rome IV criteria. 3. Aged 18-70 years, female or male. 4. Willing to paticipate in this trial and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Excluding defecation disorders related to anatomy, such as rectal prolapse, rectal protrusion> 3cm combined with other organ prolapse, pelvic floor hernia, solitary lower rectal ulcer, etc. 2. Patients with severe primary diseases such as cardiovascular, cerebrovascular, liver, kidney and hematopoietic system, and mental illness. 3. Diabetes patients with poor blood glucose control (fasting blood glucose > 7.8mmol/L). 4. Patients with severe infection and critical illness. 5. Pregnant or lactating women, allergic physique or abnormal liver function. 6. According to the judgment of the investigator, other medical history that reduces the possibility of enrollment or complicates enrollment, such as frequent changes in the working environment, may easily cause loss to follow-up. 7. Subjects who are participating in clinical studies of other drugs.

Design outcomes

Primary

MeasureTime frame
Anorectal manometry;Symptoms scale;Patient assessment of constipation quality of life;Rectal sensation;balloon expulsion test;

Countries

China

Contacts

Public ContactYibo Yao

Longhua Hospital Shanghai University of Traditional Chinese Medicine

yibo.yao@shutcm.edu.cn+86 13774320630

Outcome results

None listed

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