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The safety and efficacy of 3% polidocanol foam and diluent in the treatment of Grade I-III hemorrhoids with bleeding: an randomized controlled clinical study

The safety and efficacy of 3% polidocanol foam and diluent in the treatment of Grade I-III hemorrhoids with bleeding: an randomized controlled clinical study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400088702
Enrollment
Unknown
Registered
2024-08-26
Start date
2024-09-01
Completion date
Unknown
Last updated
2024-09-02

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

Conditions

hemorrhoids with bleeding

Interventions

Experimental group:Polidocanol diluent (3% polidocanol 2ml + normal saline 8ml) is injected by endoscope for sclerotherapy
Control group:Polidocanol foam (3% polydocanol 2ml+ air 8ml) is injected by endoscope for sclerotherapy

Sponsors

The Third People’s Hospital of Chengdu
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Male or female, aged 18-75 years (including 18 and 75 years); (2) Grade I-III internal hemorrhoids with symptoms including bleeding; (3) Voluntarily participate and sign informed consent.

Exclusion criteria

Exclusion criteria: (1) Grade IV internal hemorrhoids, mixed hemorrhoids and external hemorrhoids; (2) Internal hemorrhoids of grade I to III are accompanied by incarceration, thrombosis, ulceration, infection and other complications; (3) Severe heart, brain, lung, liver, kidney failure can not tolerate endoscopic treatment; (4) Perianal infectious disease, anal fistula, radiotherapy history and inflammatory bowel disease during active period; (5)Ppatients allergic to Polidocanol ; (6) Pregnant women.

Design outcomes

Primary

MeasureTime frame
The effectiveness of the treatment on bleeding control is evaluated at 12 and 24 weeks post-operation;The effectiveness of prolapse improvement is evaluated at 12 and 24 weeks after surgery;Endoscopy is reviewed 24 weeks after surgery and recurrence of internal hemorrhoid is assessed;

Countries

China

Contacts

Public ContactSHAN Jing

The Third People’s Hospital of Chengdu

tulip-sj@163.com+86 156 5885 0832

Outcome results

None listed

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