HemorrhoidsPhase 2/3NCT04188171
Sclerotherapy With Polidocanol Foam In The Treatment Of Hemorrhoidal Disease In Patients With Bleeding Disorders
A Phase 2/3 study testing Polidocanol foam sclerotherapy in people with Hemorrhoids and Bleeding Disorder, run by Universidade do Porto at 3 sites in Portugal.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhoids, Bleeding Disorder
- What is being tested?
- Polidocanol foam sclerotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 3 sitesPortugal
- Study dates
- 1 Aug 2018to 1 Feb 2021
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with symptomatic internal hemorrhoidal disease grades I to III submitted to sclerotherapy with polidocanol foam in three Portuguese health institutions (Centro Hospitalar Universitário do Porto, Hospital Senhora da Oliveira - Guimarães and Hospital Prof. Doutor Fernando da Fonseca, EPE - Amadora);
- Hemorrhoidal disease refractory to conservative therapy (dietary modification, intestinal transit modifiers, topical and venotropic drugs) during a period no less than 4 weeks;
Who cannot join
- Known allergy to polidocanol;
- Liver cirrhosis;
- Pregnant or lactating women;
- Inflammatory bowel disease;
- Other concomitant symptomatic perianal disease;
- History of office-based or surgical treatment of hemorrhoidal disease in the last 6 months;
- Immunosuppression.
Trial locations and contacts
3 sites in 1 country.
Portugal3 sites
Hospital Prof. Doutor Fernando da Fonseca, EPE
Amadora, 2720-276
Hospital Senhora da Oliveira
Guimarães, 4800-000
Centro Hospitalar Universitário do Porto
Porto, 4050-000
About this study
Official title: Sclerotherapy With Polidocanol Foam In The Management Of First, Second And Third-Grade Hemorrhoidal Disease In Patients With Bleeding Disorders: A Prospective Cohort Study
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.
Read the detailed 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).
- Conditions
- Hemorrhoids, Bleeding Disorder
- Being tested
- Polidocanol foam sclerotherapy
- Keywords
- Sclerotherapy, Polidocanol foam, Hemorrhoidal disease
- Medical subject headings
- Hemorrhoids, Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polidocanol foam sclerotherapyProcedure or surgery
- Preparation of the foam is done according to the Tessari technique (2 disposable 20ml syringe, a three-way tap, reusable extender adapted to intravenous needle).
- Sclerosant applied according to the Blanchard technique through a disposable transparent anoscope (patient in knee-chest position).
- In each session, treatment can be performed on more than one hemorrhoidal cushion. The maximum dose per treatment session is 20ml (mixture of 4ml of polidocanol 3% with 16ml of air).
- During the intervention period the participants are observed at 3-week intervals. The required number of sessions (maximum of 3) is determined by clinical and anoscopic evaluation.
- After the intervention period, a one-year follow-up is scheduled with medical appointments performed every 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Polidocanol foam sclerotherapy | Experimental | During the intervention period the participants are observed at 3-week intervals (maximum of 3 sessions).
The required number of polidocanol foam sclerotherapy sessions (maximum of 3) is determined by clinical and anoscopic evaluation (if the participant is non-symptomatic and/or there is no significant hemorrhoidal disease on anoscopy, the patient will not be a candidate for additional instrumental therapy moving directly to the follow-up period). After each session all patients were instructed to adopt dietary measures and adequate hydration maintaining therapy with systemic venotropic, topical and laxative if necessary.
After the intervention period, a one-year follow-up is scheduled with medical appointments performed every 3 months. Receives: Procedure: Polidocanol foam sclerotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness evaluation (therapeutic success)
For efficacy evaluation during the intervention period the outcomes will be compared between groups A and B.
Therapeutic success is a compound variable of Sodergren symptom score and bleeding grade and is subdivided in:
- Complete (Sodergren score = 0 and bleeding grade ≤ 1);
- Partial (Sodergren score> 0 and bleeding grade> 1 but with improvement over initial score); - Therapeutic failure (participants that, after 3 sessions of office-based treatment worsened or maintained the initial Sodergren score and bleeding grade).
Measured: 3 months
Safety evaluationL occurrence of complications
Comparison of the occurrence of complications in both groups A and B.
Complications are classified as:
- Mild (e.g. pain/discomfort, minor bleeding, external hemorrhoidal thrombosis not requiring surgical intervention);
- Moderate (e.g. external hemorrhoidal thrombosis requiring surgical intervention, moderate bleeding not requiring blood transfusion, urgent hemostasis or urgent surgery);
- Severe (e.g. sepsis, Fournier's gangrene, perineal abscess, bleeding with hemodynamic instability, transfusional need or urgent surgery, sexual impotence in man).
Measured: 12 months
Secondary outcomes (2)
Effectiveness evaluation (Goligher classification)
For efficacy evaluation during the intervention period the outcomes will be compared between groups A and B.
Variation of Goligher classification before and after the intervention.
Measured: 3 months
Effectiveness evaluation (number of office-based sessions)
Number of office-based therapy sessions and polidocanol foam dose applied during the intervention period (comparing groups A and B).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start1 Aug 2018
- Primary completion1 Feb 2020
- Study completion1 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for HemorrhoidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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 and safety outcomes will be compared between two groups of patients: with bleeding disorders (Group A) and without bleeding disorders (Group B).
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paulo Sérgio Durão Salgueiro, Universidade do Porto
- Investigators
- Paulo Salgueiro, MD, Principal investigator, Centro Hospitalar do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04188171
- Sponsor's protocol ID
- 12422301
- Status last verified
- Aug 2020
- First submitted
- 2 Dec 2019
- Last updated
- 19 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Halverson A. Hemorrhoids. Clin Colon Rectal Surg. 2007 May;20(2):77-85. doi: 10.1055/s-2007-977485.
PubMed 20011381Agbo SP. Surgical management of hemorrhoids. J Surg Tech Case Rep. 2011 Jul;3(2):68-75. doi: 10.4103/2006-8808.92797.
PubMed 22413048Riss S, Weiser FA, Schwameis K, Riss T, Mittlbock M, Steiner G, Stift A. The prevalence of hemorrhoids in adults. Int J Colorectal Dis. 2012 Feb;27(2):215-20. doi: 10.1007/s00384-011-1316-3. Epub 2011 Sep 20.
PubMed 21932016Everhart JE, Ruhl CE. Burden of digestive diseases in the United States part II: lower gastrointestinal diseases. Gastroenterology. 2009 Mar;136(3):741-54. doi: 10.1053/j.gastro.2009.01.015. Epub 2009 Jan 21. No abstract available.
PubMed 19166855Johanson JF, Sonnenberg A. The prevalence of hemorrhoids and chronic constipation. An epidemiologic study. Gastroenterology. 1990 Feb;98(2):380-6. doi: 10.1016/0016-5085(90)90828-o.
PubMed 2295392Qureshi WA. Office management of hemorrhoids. Am J Gastroenterol. 2018 Jun;113(6):795-798. doi: 10.1038/s41395-018-0020-0. No abstract available.
PubMed 29487411Pucher PH, Qurashi M, Howell AM, Faiz O, Ziprin P, Darzi A, Sodergren MH. Development and validation of a symptom-based severity score for haemorrhoidal disease: the Sodergren score. Colorectal Dis. 2015 Jul;17(7):612-8. doi: 10.1111/codi.12903.
PubMed 25603811Pengo V, Pegoraro C, Cucchini U, Iliceto S. Worldwide management of oral anticoagulant therapy: the ISAM study. J Thromb Thrombolysis. 2006 Feb;21(1):73-7. doi: 10.1007/s11239-006-5580-y.
PubMed 16475046Yusuf S, Islam S, Chow CK, Rangarajan S, Dagenais G, Diaz R, Gupta R, Kelishadi R, Iqbal R, Avezum A, Kruger A, Kutty R, Lanas F, Lisheng L, Wei L, Lopez-Jaramillo P, Oguz A, Rahman O, Swidan H, Yusoff K, Zatonski W, Rosengren A, Teo KK; Prospective Urban Rural Epidemiology (PURE) Study Investigators. Use of secondary prevention drugs for cardiovascular disease in the community in high-income, middle-income, and low-income countries (the PURE Study): a prospective epidemiological survey. Lancet. 2011 Oct 1;378(9798):1231-43. doi: 10.1016/S0140-6736(11)61215-4. Epub 2011 Aug 26.
PubMed 21872920Sorensen R, Hansen ML, Abildstrom SZ, Hvelplund A, Andersson C, Jorgensen C, Madsen JK, Hansen PR, Kober L, Torp-Pedersen C, Gislason GH. Risk of bleeding in patients with acute myocardial infarction treated with different combinations of aspirin, clopidogrel, and vitamin K antagonists in Denmark: a retrospective analysis of nationwide registry data. Lancet. 2009 Dec 12;374(9706):1967-74. doi: 10.1016/S0140-6736(09)61751-7.
PubMed 20006130Rothberg MB, Celestin C, Fiore LD, Lawler E, Cook JR. Warfarin plus aspirin after myocardial infarction or the acute coronary syndrome: meta-analysis with estimates of risk and benefit. Ann Intern Med. 2005 Aug 16;143(4):241-50. doi: 10.7326/0003-4819-143-4-200508160-00005.
PubMed 16103468Holster IL, Valkhoff VE, Kuipers EJ, Tjwa ETTL. New oral anticoagulants increase risk for gastrointestinal bleeding: a systematic review and meta-analysis. Gastroenterology. 2013 Jul;145(1):105-112.e15. doi: 10.1053/j.gastro.2013.02.041. Epub 2013 Mar 5.
PubMed 23470618He Y, Wong IC, Li X, Anand S, Leung WK, Siu CW, Chan EW. The association between non-vitamin K antagonist oral anticoagulants and gastrointestinal bleeding: a meta-analysis of observational studies. Br J Clin Pharmacol. 2016 Jul;82(1):285-300. doi: 10.1111/bcp.12911. Epub 2016 Apr 15.
PubMed 26889922Pannach S, Goetze J, Marten S, Schreier T, Tittl L, Beyer-Westendorf J. Management and outcome of gastrointestinal bleeding in patients taking oral anticoagulants or antiplatelet drugs. J Gastroenterol. 2017 Dec;52(12):1211-1220. doi: 10.1007/s00535-017-1320-7. Epub 2017 Feb 16.
PubMed 28210867Craddock CG Jr, Fenninger LD, Simmons B. Hemophilia: Problem of Surgical Intervention for Accompanying Diseases. Review of the Literature and Report of a Case. Ann Surg. 1948 Nov;128(5):888-903. doi: 10.1097/00000658-194811000-00002. No abstract available.
PubMed 17859247
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sclerotherapy With Polidocanol Foam In The Management Of First, Second And Third-Grade Hemorrhoidal Disease In Patients With Bleeding Disorders: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04188171
- Acronym / sponsor ID
- 12422301
- Conditions
- Hemorrhoids, Bleeding Disorder
- Keywords
- Sclerotherapy, Polidocanol foam, Hemorrhoidal disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Feb 2021 (estimated)
- First posted
- 5 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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 and safety outcomes will be compared between two groups of patients: with bleeding disorders (Group A) and without bleeding disorders (Group B).
| Arm | Type | Receives |
|---|---|---|
| Polidocanol foam sclerotherapy | Experimental | Procedure: Polidocanol foam sclerotherapyDuring the intervention period the participants are observed at 3-week intervals (maximum of 3 sessions). The required number of polidocanol foam sclerotherapy sessions (maximum of 3) is determined by clinical and anoscopic evaluation (if the participant is non-symptomatic and/or there is no significant hemorrhoidal disease on anoscopy, the patient will not be a candidate for additional instrumental therapy moving directly to the follow-up period). After each session all patients were instructed to adopt dietary measures and adequate hydration maintaining therapy with systemic venotropic, topical and laxative if necessary. After the intervention period, a one-year follow-up is scheduled with medical appointments performed every 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients with symptomatic internal hemorrhoidal disease grades I to III submitted to sclerotherapy with polidocanol foam in three Portuguese health institutions (Centro Hospitalar Universitário do Porto, Hospital Senhora da Oliveira - Guimarães and Hospital Prof. Doutor Fernando da Fonseca, EPE - Amadora);
- Hemorrhoidal disease refractory to conservative therapy (dietary modification, intestinal transit modifiers, topical and venotropic drugs) during a period no less than 4 weeks;
Key exclusion criteria (7 listed)
- Known allergy to polidocanol;
- Liver cirrhosis;
- Pregnant or lactating women;
- Inflammatory bowel disease;
- Other concomitant symptomatic perianal disease;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polidocanol foam sclerotherapy* Preparation of the foam is done according to the Tessari technique (2 disposable 20ml syringe, a three-way tap, reusable extender adapted to intravenous needle). * Sclerosant applied according to the Blanchard technique through a disposable transparent anoscope (patient in knee-chest position). * In each session, treatment can be performed on more than one hemorrhoidal cushion. The maximum dose per treatment session is 20ml (mixture of 4ml of polidocanol 3% with 16ml of air). * During the intervention period the participants are observed at 3-week intervals. The required number of sessions (maximum of 3) is determined by clinical and anoscopic evaluation. * After the intervention period, a one-year follow-up is scheduled with medical appointments performed every 3 months. | Procedure or surgery | Polidocanol foam sclerotherapy |
Primary outcome
Effectiveness evaluation (therapeutic success)
Time frame: 3 months
For efficacy evaluation during the intervention period the outcomes will be compared between groups A and B. Therapeutic success is a compound variable of Sodergren symptom score and bleeding grade and is subdivided in: * Complete (Sodergren score = 0 and bleeding grade ≤ 1); * Partial (Sodergren score> 0 and bleeding grade> 1 but with improvement over initial score); - Therapeutic failure (participants that, after 3 sessions of office-based treatment worsened or maintained the initial Sodergren score and bleeding grade).
Safety evaluationL occurrence of complications
Time frame: 12 months
Comparison of the occurrence of complications in both groups A and B. Complications are classified as: * Mild (e.g. pain/discomfort, minor bleeding, external hemorrhoidal thrombosis not requiring surgical intervention); * Moderate (e.g. external hemorrhoidal thrombosis requiring surgical intervention, moderate bleeding not requiring blood transfusion, urgent hemostasis or urgent surgery); * Severe (e.g. sepsis, Fournier's gangrene, perineal abscess, bleeding with hemodynamic instability, transfusional need or urgent surgery, sexual impotence in man).
2 secondary outcomes
Effectiveness evaluation (Goligher classification)
Time frame: 3 months
Effectiveness evaluation (number of office-based sessions)
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2020.
- Results publication: PubMed 20011381Halverson A. Hemorrhoids. Clin Colon Rectal Surg. 2007 May;20(2):77-85. doi: 10.1055/s-2007-977485.
- Results publication: PubMed 22413048Agbo SP. Surgical management of hemorrhoids. J Surg Tech Case Rep. 2011 Jul;3(2):68-75. doi: 10.4103/2006-8808.92797.
- Results publication: PubMed 21932016Riss S, Weiser FA, Schwameis K, Riss T, Mittlbock M, Steiner G, Stift A. The prevalence of hemorrhoids in adults. Int J Colorectal Dis. 2012 Feb;27(2):215-20. doi: 10.1007/s00384-011-1316-3. Epub 2011 Sep 20.
- Results publication: PubMed 19166855Everhart JE, Ruhl CE. Burden of digestive diseases in the United States part II: lower gastrointestinal diseases. Gastroenterology. 2009 Mar;136(3):741-54. doi: 10.1053/j.gastro.2009.01.015. Epub 2009 Jan 21. No abstract available.
- Results publication: PubMed 2295392Johanson JF, Sonnenberg A. The prevalence of hemorrhoids and chronic constipation. An epidemiologic study. Gastroenterology. 1990 Feb;98(2):380-6. doi: 10.1016/0016-5085(90)90828-o.
- Results publication: PubMed 29487411Qureshi WA. Office management of hemorrhoids. Am J Gastroenterol. 2018 Jun;113(6):795-798. doi: 10.1038/s41395-018-0020-0. No abstract available.
- Results publication: PubMed 25603811Pucher PH, Qurashi M, Howell AM, Faiz O, Ziprin P, Darzi A, Sodergren MH. Development and validation of a symptom-based severity score for haemorrhoidal disease: the Sodergren score. Colorectal Dis. 2015 Jul;17(7):612-8. doi: 10.1111/codi.12903.
- Results publication: PubMed 16475046Pengo V, Pegoraro C, Cucchini U, Iliceto S. Worldwide management of oral anticoagulant therapy: the ISAM study. J Thromb Thrombolysis. 2006 Feb;21(1):73-7. doi: 10.1007/s11239-006-5580-y.
- Results publication: PubMed 21872920Yusuf S, Islam S, Chow CK, Rangarajan S, Dagenais G, Diaz R, Gupta R, Kelishadi R, Iqbal R, Avezum A, Kruger A, Kutty R, Lanas F, Lisheng L, Wei L, Lopez-Jaramillo P, Oguz A, Rahman O, Swidan H, Yusoff K, Zatonski W, Rosengren A, Teo KK; Prospective Urban Rural Epidemiology (PURE) Study Investigators. Use of secondary prevention drugs for cardiovascular disease in the community in high-income, middle-income, and low-income countries (the PURE Study): a prospective epidemiological survey. Lancet. 2011 Oct 1;378(9798):1231-43. doi: 10.1016/S0140-6736(11)61215-4. Epub 2011 Aug 26.
- Results publication: PubMed 20006130Sorensen R, Hansen ML, Abildstrom SZ, Hvelplund A, Andersson C, Jorgensen C, Madsen JK, Hansen PR, Kober L, Torp-Pedersen C, Gislason GH. Risk of bleeding in patients with acute myocardial infarction treated with different combinations of aspirin, clopidogrel, and vitamin K antagonists in Denmark: a retrospective analysis of nationwide registry data. Lancet. 2009 Dec 12;374(9706):1967-74. doi: 10.1016/S0140-6736(09)61751-7.
- Results publication: PubMed 16103468Rothberg MB, Celestin C, Fiore LD, Lawler E, Cook JR. Warfarin plus aspirin after myocardial infarction or the acute coronary syndrome: meta-analysis with estimates of risk and benefit. Ann Intern Med. 2005 Aug 16;143(4):241-50. doi: 10.7326/0003-4819-143-4-200508160-00005.
- Results publication: PubMed 23470618Holster IL, Valkhoff VE, Kuipers EJ, Tjwa ETTL. New oral anticoagulants increase risk for gastrointestinal bleeding: a systematic review and meta-analysis. Gastroenterology. 2013 Jul;145(1):105-112.e15. doi: 10.1053/j.gastro.2013.02.041. Epub 2013 Mar 5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paulo Salgueiro, MD principal investigator
Centro Hospitalar do Porto
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Polidocanol foam sclerotherapy in people with Hemorrhoids and Bleeding Disorder, run by Universidade do Porto at 3 sites in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness evaluation (therapeutic success) (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04188171, which also lists 36 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2020.