Status:
UNKNOWN
A Comparison of Flexible Endoscopic Polidocanol Liquid and Foam Sclerotherapy in Cirrhotic Patients With Bleeding From Internal Hemorrhoids
Lead Sponsor:
Institute of Liver and Biliary Sciences, India
Conditions:
Liver Cirrhosis
Internal Hemorrhoid
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
Haemorrhoids are the most common proctologic disease, affecting up to 36% of people in the developed world. Sclerotherapy is defined as the injection of sclerosing agents at the apex of the internal he...
Detailed Description
Hypothesis :- Polidocanol foam sclerotherapy is more effective than liquid polidocanol sclerotherapy, for bleeding cessation from internal hemorrhoids in cirrhotic patients. Aim and Objective - To co...
Eligibility Criteria
Inclusion
- Cirrhotic/ACLF patients with ano-rectal bleeding, either ongoing or within last 1-week, judged to be hemorrhoidal in origin based on clinical features and endoscopy evaluation.
Exclusion
- Coagulopathy threshold of INR \>2.0 and/or platelet count \<50,000/mm3.
- Antiplatelet or anticoagulants use.
- Immunosuppressive medications (including steroids \>20mg/d or equivalent for \>2 weeks).
- Grade IV internal hemorrhoids.
- Thrombosed or strangulated IH or EH.
- Previous EST or RBL in last 1-year.
- Co-existing ano-rectal diseases like perianal abscess, stricture, fistula, anal malignancies, ano-rectal stenosis, radiation proctitis, or proctitis.
- Patients not capable of understanding and signing the informed consent.
- Pregnancy.
- Bronchial Asthma.
Key Trial Info
Start Date :
September 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06031740
Start Date
September 7 2023
End Date
August 31 2024
Last Update
September 15 2023
Active Locations (1)
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1
Institute of Liver & Biliary Sciences (ILBS)
New Delhi, National Capital Territory of Delhi, India, 110070