Flexible Endoscopic Polidocanol Liquid and Foam Sclerotherapy for internal hemmhoids.
- Conditions
- Health Condition 1: K77- Liver disorders in diseases classified elsewhere
- Registration Number
- CTRI/2023/10/058768
- Lead Sponsor
- Institute of Liver and Biliary Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1) 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.
1.Coagulopathy threshold of INR >2.0 and/or platelet count <50,000/mm3.
2.Antiplatelet or anticoagulants use.
3.Immunosuppressive medications (including steroids >20mg/d or equivalent for >2 weeks).
4.Grade IV internal hemorrhoids.
5.Thrombosed or strangulated IH or EH.
6.Previous EST or RBL in last 1-year.
7.Co-existing ano-rectal diseases like perianal abscess, stricture, ?stula, anal malignancies, ano-rectal stenosis, radiation proctitis, or proctitis.
8.Patients not capable of understanding and signing the informed consent.
9.Pregnancy.
10.Bronchial Asthma.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method o recurrence of hemorrhoidal bleeding episodes at 1-week after endotherapyTimepoint: 1 week
- Secondary Outcome Measures
Name Time Method Adverse events/ local infectious complications after endotherapyTimepoint: 8 weeks;Ano-rectal bleeding at 4-wks, defined by Giamundo scoreTimepoint: 4 weeks;Ano-rectal bleeding at 8-wks, defined by Giamundo scoreTimepoint: 8 weeks;Proportion of cirrhotic patients with bleeding hemorrhoids, with coexisting rectal varices and/or portal colopathy.Timepoint: 8 weeks;Proportion of patients requiring a 2nd treatment session within 8-wks.Timepoint: 8 weeks;Proportion of patients requiring BT for hemorrhoidal bleeding within 8 wksTimepoint: 8 weeks;Proportion of patients with failed endotherapyTimepoint: 8 weeks;Relationship of MELD score (4-40) with no recurrence of bleeding at 7days.Timepoint: 7 days