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A Comparison of Flexible Endoscopic Polidocanol Liquid and Foam Sclerotherapy in Cirrhotic Patients With Bleeding From Internal Hemorrhoids

NCT06031740 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-09-15

No results posted yet for this study

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 hemorrhoidal complex, above the dentate line, leading to scarring, fibrosis, and fixation of the hemorrhoids. Sclerotherapy as a treatment of internal hemorrhoids has been used for a long time by surgeons, using proctoscopic exposure. Even though flexible instruments can be expected to have better manoeuvrability and target site exposure. There is no consensus amongst the major guidelines as to which grade of haemorrhoid that sclerotherapy should be used, whether it is equivalent or inferior to rubber bad ligation (RBL), whether sclerotherapy should be used at all for the treatment of IH, what is the effect of PHT on hemorrhoid prevalence and propensity to bleed, differentiation of internal hemorrhoids from rectal varices, data on EBL or EST in cirrhotics with hemorrhoids, safety of endotherapy with underlying coagulopathy and concerns for infectious complications.

Conditions

Interventions

PROCEDURE

Sclerotherapy with 1.5% polidocanol

2mL (3%) polidocanol = 60mg; maximal dose: 1mL/column and 4mL/session. \- Group 2: Foam sclerotherapy.

PROCEDURE

Foam sclerotherapy.

Tessari's technique; 4mL 3% poilidocanol +16mL air; maximal dose: 2mL/column and 20mL/session.

Sponsors & Collaborators

  • Institute of Liver and Biliary Sciences, India

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-07
Primary Completion
2024-08-31
Completion
2024-08-31

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06031740 on ClinicalTrials.gov