| Registry | NCT07866248 |
|---|---|
| Status | Not yet recruiting |
| Phase | Phase 4 |
| Study type | Interventional; na, single group, masking: none, treatment |
| Enrollment | 130 (Estimated) |
| Sponsor | Radwa Hussein Mohammed Hasanen (Other) |
| Conditions | Internal Piles Sclerotherapy, Internal Hemorrhoids |
| Interventions | Standardized 3% Polidocanol Foam Sclerotherapy (Procedure) |
| Dates | start 2026-10-01 (estimated), primary completion 2028-06-01 (estimated), completion 2028-09-01 (estimated), first posted 2026-10-08, last updated 2026-10-08 |
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All trials for Internal Piles Sclerotherapy All trials for Internal Hemorrhoids All trials of Standardized 3% Polidocanol Foam Sclerotherapy
To evaluate the efficacy, durability, safety, and clinical/endoscopic outcomes of standardized 3% polidocanol foam sclerotherapy in patients with symptomatic grade II-III internal hemorrhoids over a 12-month follow-up period.
Hemorrhoidal disease (HD) affects approximately 4% of the population . Its management is typically guided by the Goligher classification and the impact of symptoms on the patient's quality of life. While grade IV HD is usually treated with surgical excision, lower-grade cases can often be managed with less invasive techniques, including office-based procedures such as sclerotherapy and rubber band ligation (RBL), when conservative treatments fail. Sclerotherapy dates back to the nineteenth century as the first minimally invasive treatment described for HD .
Polidocanol (hydroxy-polyethoxy-dodecane) is a synthetic long-chain fatty alcohol, was first used as a sclerosing agent in Germany in the 1960s. polidicanol can be used in treatment of spider veins, reticular veins, varicose veins and hemorrhoids .
Polidocanol works as detergent that cause endothelial destruction and thrombosis, induce sterile inflammation so result in fibrosis and tissue atrophy with vascular obliteration shrinkage and fixation of hemorrhodal cushion so reduction of bleeding and prolapse.
More recently, polidocanol has emerged as a sclerosing agent, first gaining widespread use in the treatment of varicose veins, before being successfully applied to HD. Its improved safety profile progressively replaced phenol oil as the preferred sclerosing agent, and the introduction of polidocanol foam further enhanced its efficacy compared to the original liquid formulation .
The use of polidocanol in foam form has gained attention owing to its practical advantages, including cost-effectiveness, less pain, fewer required office-based sessions, rapid recovery as patient can return to normal activity next day and lower incidence of bleeding complications so suitable for patients with bleeding disorders.
These advancements have led to a shifting paradigm, with sclerotherapy increasingly being considered a first-line treatment for symptomatic grade II-III HD, potentially reserving RBL for recurrent cases .
| Arm | Type | Interventions | Description |
|---|---|---|---|
| 3% polidocanol foam injection in internal hemorrhoids for sclerotherapy | Active comparator | Procedure: Standardized 3% Polidocanol Foam Sclerotherapy | 3% polidocanol foam, Sims position, Open-ended anoscope, use of 20-G needle, Injection above dentate line, Intra-pile injection, 2 ml foam / symptomatic hemorrhoidal cushion, Maximum 3 cushions / session, Maximum plained study dose 6 ml foam / session , Assessment at 4 weeks |
Sex: All, ages: 18 Years to 80 Years
Inclusion Criteria:
1. Age ≥18 years.
2. Symptomatic internal hemorrhoidal disease.
3. Goligher grade II or III hemorrhoids.
4. Predominant hemorrhoidal bleeding (>or equal 2 episodes of rectal bleeding/ week in last 4 weeks) and/or prolapse.
5. Persistent symptoms despite 4 to 6 weeks of conservative treatment (high fibers diet 25/30 g/day, increase water intake, avoid straining, stool softening and topical treatment as anesthetics and corticosteroids containing preparations) .
6. Suitable for outpatient Polidocanol foam sclerotherapy treatment.
7. Willingness to comply with the study protocol.
Exclusion Criteria:
1. Goligher grade IV hemorrhoids.
2. Predominantly external hemorrhoidal disease.
3. Acute thrombosed hemorrhoids.
4. Active anorectal infection.
5. Anal fissure or fistula responsible for presenting symptoms.
6. Known colorectal malignancy.
7. Active inflammatory bowel disease involving the anorectal region.
8. Uncorrected bleeding disorder.
9. Known hypersensitivity to polidocanol.
10. Previous hemorrhoidal surgery substantially altering anorectal anatomy.
11. Severe uncontrolled systemic illness preventing the procedure.
12. Pregnancy where treatment is considered inappropriate according to institutional policy.
13. Inability to provide informed consent.
14. Inability to complete follow-up.
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