Clinical Trials Logo

Clinical Trial Summary

Treatment of hemorrhoidal disease includes a conservative approach (dietary and behavioral measures, venotropic and topical medication), office-based treatments and surgery. Rubber banding is currently considered the instrumental method of choice in the treatment of hemorrhoidal disease grades I to III (Goligher's classification). However, its use in patients with bleeding disorders is not recommended. Sclerotherapy can be performed in these patients since the hemorrhagic risk is very low. The most commonly used agent for sclerotherapy is liquid polidocanol. Polidocanol foam seems to be more effective than the liquid formulation and is safe in the treatment of hemorrhoidal disease even in patients with coagulation disorders. This study is aimed to evaluate the efficacy and safety of polidocanol foam sclerotherapy in the treatment of hemorrhoidal disease grades I to III in patients with bleeding disorders.


Clinical Trial Description

Internal hemorrhoidal disease is classified according to the Goligher classification into grades I, II, III and IV according to its grade of prolapse and reducibility. The treatment of patients should be oriented by the presence of symptoms and the impact on life quality, aspects that are valued on the Sodergren scale.

The hemorrhoidal bleeding, usually mild, may be severe in patients under antithrombotic medications (antiplatelet or anticoagulant) as well as in patients with bleeding disorders non-induced by drugs. With the increase of life expectancy and the high prevalence of atrial fibrillation, the consumption of anticoagulants has also been increasing. Similarly, the use of antiplatelet medication has also increased, especially through its use in the primary and secondary prevention of cardiovascular events. Vitamin K antagonists and antiplatelet drugs are associated with an incidence of digestive bleeding between 1.5% - 4.5% with a short-term mortality of 10-15%. The relation between the use of new oral anticoagulants (NOACs) and digestive bleeding remains a matter of debate, with some studies showing different results when comparing bleeding risk with vitamin K antagonists. Similar to what happen with this subset of patients, those with inherited bleeding disorders are a known subgroup of patients predisposed to hemorrhagic complications. Hemophilia represents the main cause of inherited defects of clotting factors VIII and IX. With the advent of intravenous clotting factors concentrates, the perioperative mortality in this subgroup as decreased in the mid-20th century. However patients with this hematologic disease still have a higher risk of bleeding, delayed wound healing and postoperative infections. To the investigator's knowledge little is known about the prevalence of hemorrhoidal disease in patients with inherited bleeding disorders. Bearing in mind the high rate of surgical complications in these patients, they could represent the ideal candidates for less invasive office-based hemorrhoidal therapy. Instrumental, office-based treatment is reserved for internal hemorrhoidal disease grades I to III. Regardless of the applied technique, the goal is to decrease vascularization, decrease hemorrhoidal volume and increase the fixation of the fibrovascular pedicle to the rectal wall, thus treating the bleeding and hemorrhoidal prolapse. Rubber band ligation is considered the method of choice in the treatment of hemorrhoidal disease. However, its use is associated to bleeding rates after procedure ranging between 3.5 - 50% and late bleeding rates between 13% - 18,3% that may occur until 7-14 days after treatment. The hemorrhagic event is significant in 0.8% of cases and may even prove fatal. For this reason, this technique is contraindicated in patients with bleeding disorders. In patients on antithrombotic medication, discontinuation of this medication is recommended for 7 days before the ligation procedure and 7-10 days after the procedure, which substantially increases the risk of cardioembolic events. In contrast, sclerotherapy is a technique with a low rate of bleeding complications and can be used to treat hemorrhoidal disease grades I to III. After intravascular injection of sclerosing agent above the pectineal line - Blanchard technique - an inflammatory and fibrotic response is obtained that interrupts the blood supply. Although there are multiple sclerosing agents, in Portugal, the most frequently used is liquid polidocanol. As a nonionic detergent its use as a foam (obtained by the technique of Tessari which uses a device that combines two syringes and a three-way tap in which the polidocanol is mixed with air under mechanical force) appears to be associated with greater efficacy even with lower doses of sclerosing agent. Sclerotherapy with liquid polidocanol is effective in the treatment of grade I hemorrhoidal disease with a study demonstrating superiority of foam formulation in this grade of hemorrhoidal disease. A recently published Portuguese study sought to study the efficacy and safety of foamed polidocanol sclerotherapy in patients with grade I to IV hemorrhoidal disease. On the findings, which included 2000 participants, 210 of them on anticoagulant and/or dual antiplatelet therapy, the authors conclude that this instrumental procedure is effective and safe even in patients on antithrombotic therapy. However, no comparison was made between the incidence of complications occurred in this subgroup of patients with the remaining patients without antithrombotic therapy. As far as we know there are no published studies comparing polidocanol foam sclerotherapy to other ablative techniques.

The investigators are conducting a multicentric longitudinal prospective study including adult patients, with or without bleeding disorders, with hemorrhoidal disease grades I to III submitted to polidocanol foam sclerotherapy in three health institutions during an inclusion period of 1.5 years. Efficacy is assessed using Sodergren score of symptoms, bleeding and Goligher grades, and recurrence during follow-up. For the safety evaluation, complications are recorded. Efficacy and safety outcomes will be compared between two groups of patients: with bleeding disorders (Group A) and without bleeding disorders (Group B). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04188171
Study type Interventional
Source Universidade do Porto
Contact
Status Active, not recruiting
Phase Phase 2/Phase 3
Start date August 1, 2018
Completion date February 1, 2021

See also
  Status Clinical Trial Phase
Completed NCT06216223 - Laser Versus Surgery in Anal Diseases in Inflammatory Bowel Patients N/A
Withdrawn NCT02851940 - Pain and Bleeding Following Hypertonic Saline Sclerotherapy Compared to Brand Ligation for Symptomatic Hemorrhoids N/A
Recruiting NCT02301052 - Evaluation of Allium Ampeloprasum Spp.Iranicum Cream Effect for the Management of Hemorrhoids Symptoms Phase 1/Phase 2
Completed NCT02216305 - HAL-RAR Versus Hemorrhoidectomy in the Treatment of Grade III-IV Hemorrhoids. Prospective, Randomized Trial N/A
Completed NCT02358174 - Hemorrhoids and Metalloproteinases, Observational Study N/A
Completed NCT01483833 - Efficacy Study of Iferanserin to Treat Hemorrhoids Phase 2
Completed NCT00397137 - Stapled Anopexy Versus Closed Haemorrhoidectomy for Haemorrhoids N/A
Completed NCT00841620 - Symptom Control 1-year After Circular Stapler Anopexy or Diathermy Excision for Prolapsed Haemorhoids Phase 4
Completed NCT06459739 - Effect of Sacral Erector Spinae Plane Block on Hemorrhoid and Pilonidal Sinus Surgery N/A
Completed NCT04276298 - Topical Analgesia Post-Haemorrhoidectomy Phase 2/Phase 3
Completed NCT04675177 - Polidocanol Foam VS Artery Ligation in Hemorrhoidal Disease Phase 2/Phase 3
Recruiting NCT05889962 - Ultrasound-guided Pudendal Nerve Block for Pain After Hemorrhoidectomy N/A
Recruiting NCT01961739 - Topical 2% Lidocaine for the Treatment of Symptomatic Hemorrhoids Phase 2/Phase 3
Active, not recruiting NCT02061176 - THD Versus Open Haemorrhoidectomy N/A
Withdrawn NCT00512044 - Local Versus General Anaesthesia in Stapled Hemorrhoidectomy Phase 4
Completed NCT04031131 - The Use of Topical Anaesthetic in the Banding of Internal Haemorrhoids Phase 2
Recruiting NCT04329364 - RCT Comparing Conventional Haemorrhoidectomy With Laser Haemorrhoidoplasty Phase 2/Phase 3
Completed NCT05247333 - Implementation of a Minor Ailment Service in Community Pharmacy Practice N/A
Completed NCT04567485 - Impact of Moderate to Severe Pain in the Post-intervention Monitoring Room After Hemorrhoidectomy on the Length of Stay in the Outpatient Surgery Unit
Completed NCT03298997 - Ligation and Hemorrhoidopexy Technique Versus Ligation of Hemorrhoidal Arteries Using Ultrasound for Hemorrhoids N/A