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To compare outcomes of 3 percentage polidocanol sclerotherapy versus Modified Barrons rubber band ligation in the management of grade 2 internal hemorrhoidal disease

Comparative analysis between outcomes of 3 percentage polidocanol sclerotherapy versus Modified Barrons rubber band ligation in the management of grade 2 internal hemorrhoidal disease : A non inferiority randomised control trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/02/080085
Enrollment
332
Registered
2025-02-07
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

Health Condition 1: K641- Second degree hemorrhoids

Interventions

Intervention1: 3 percentage polidocanol: In group A the participants will be treated with 4 ml 3 percentage polidocanol foam via generously lubricated Kelly proctoscope Modified Tessari technique will

Sponsors

AIIMS Patna
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age 18 years or older with grade 2 hemorrhoidal disease giving consent for participation Refractory to conservative management given for at least 1 month

Exclusion criteria

Exclusion criteria: Grade 1 3 and 4 hemorrhoidal disease Associated complications like strangulation or thrombosis Patients with external hemorrhoids Associated perianal fissure or fistula Patients who have undergone treatment for hemorrhoidal disease within last 12 months regardless of the type of treatment Patients with Inflammatory Bowel Disease Patients with coagulopathies arising from any cause or on anti-coagulation therapy Immunocompromised individuals Pregnant females

Design outcomes

Primary

MeasureTime frame
To assess the patient related outcomes blood loss pain prolapse itching soiling of 3 percentage polidocanol Sclerotherapy as compared to Modified Barrons Rubber Band Ligation in treatment of grade 2 internal haemorrhoidal disease using Patient Reported Outcome Measures Haemorrhoidal Impact and Satisfaction Score PROM HISS questionnaireTimepoint: day 0 1 week 6 weeks 3 months—

Secondary

MeasureTime frame
To assess the complication rate of 3 percentage polidocanol Sclerotherapy as compared to Modified Barrons Rubber Band Ligation in treatment of grade 2 internal haemorrhoidal diseaseTimepoint: 6 weeks 3 months;To assess the recurrence rate of 3 percentage polidocanol Sclerotherapy as compared to Modified Barrons Rubber Band Ligation in treatment of grade 2 internal haemorrhoidal disease where recurrence means subjective return of symptoms as told by patientTimepoint: 3 months—

Countries

India

Contacts

Public ContactDr Shiv Shankar Paswan

all india institute of medical sciences patna

shubhswarnima@gmail.com7488836504

Outcome results

None listed

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