Evaluation of Polidocanol Foam Sclerotherapy in Symptomatic Internal Hemorrhoids: A Prospective Study
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorRadwa Hussein Mohammed Hasanen
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years.
Symptomatic internal hemorrhoidal disease.
Goligher grade II or III hemorrhoids.
Predominant hemorrhoidal bleeding (>or equal 2 episodes of rectal bleeding/ week in last 4 weeks) and/or prolapse.
Disqualifiers
Goligher grade IV hemorrhoids.
Predominantly external hemorrhoidal disease.
Acute thrombosed hemorrhoids.
Active anorectal infection.
Trial design
Design model
Single group
Treatments tested in this trial
Standardized 3% Polidocanol Foam Sclerotherapy
Procedure/Surgery3% 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
Treatment groups
130 Participants
are divided into 1 treatment groupGroup A: 3% polidocanol foam injection in internal hemorrhoids for sclerotherapyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Sustained treatment success at 12 months
A patient will be classified as having sustained treatment success if at 12 months all of the following are satisfied: clinically meaningful improvement from baseline; no clinically significant recurrent bleeding; no persistent clinically significant prolapse requiring regular manual reduction; no need for surgical hemorrhoidectomy; no need for another hemorrhoidal intervention beyond the protocolized maximum of two PFS sessions; and satisfactory patient-reported outcome.
Time frame
12 months follow upLocations
Sponsors and contacts
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Radwa Hussein Mohammed Hasanen
Lead sponsor
Assiut University
Sponsor institution
Source ClinicalTrials.gov
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