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Polidocanol Foam Versus Rubber Band Ligation in the Treatment of Hemorrhoidal Disease

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ClinicalTrials.gov Identifier: NCT04091763
Recruitment Status : Recruiting
First Posted : September 17, 2019
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
Paulo Sérgio Durão Salgueiro, Universidade do Porto

Brief Summary:

Background: Hemorrhoidal disease is a common benign condition seen frequently in clinical settings. Rubber band ligation and sclerotherapy have proven to be the office-based procedures of choice in hemorrhoidal disease, with various studies reporting rubber band ligation as being more effective but also more painful and bleeding prone than sclerotherapy with liquid polidocanol. However, there are no studies comparing rubber band ligation and sclerotherapy with polidocanol foam, a new type of sclerosant agent that has already proved to be more effective and safer than liquid polidocanol in grade I hemorrhoidal disease.

The present study was designed to establish the clinical effectiveness and safety of sclerotherapy with polidocanol foam compared with rubber band ligation.

Methods: This randomized controlled trial includes patients with symptomatic hemorrhoidal disease grades I to III. The participants were randomly assigned (in a 1:1 ratio) to either rubber band ligation or sclerotherapy with polidocanol foam, stratified by grade of hemorrhoidal disease. During the intervention period the patients are submitted to one of the office-based procedures and, afterwards, in the follow-up period, evaluated every three months for a total period of one year.

The efficacy outcomes include symptom resolution, number of treatment sessions needed to achieve therapeutic success and evolution of hemorrhoidal disease grade in the intervention period and, during follow-up, recurrence incidence. Primary safety outcomes include the occurrence of any complication related to the office-based procedures.


Condition or disease Intervention/treatment Phase
Hemorrhoids, Internal Drug: Polidocanol Injectable Foam Device: Rubber band ligation Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomly assigned to either rubber band ligation or sclerotherapy with polidocanol foam, stratified by grade of hemorrhoidal disease
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sclerotherapy With Polidocanol Foam Versus Rubber Band Ligation in the Treatment of First, Second and Third-Grade Hemorrhoidal Disease: a Randomized, Controlled Trial
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemorrhoids
Drug Information available for: Polidocanol

Arm Intervention/treatment
Experimental: Polidocanol foam sclerotherapy
  1. Preparation of the polidocanol foam according to Tessari technique immediately before application (so that the "microbubbles" of the foam did not disintegrate);
  2. Application according to the Blanchard technique (Fig. 2) through a disposable transparent anoscope, with the patient in jackknife position, using a 20mL disposable syringe of the mixture (polidocanol + air) and a reusable 10 cm syringe extender adapted to an intravenous needle;
  3. Patients treated in a maximum of 3 sessions at 3 weeks intervals;
  4. Maximum dose per treatment session of 20mL of mixture of 4mL of polidocanol 3% with 16mL of air;
  5. In each session more than one hemorrhoid cushion could be treated.
Drug: Polidocanol Injectable Foam

Two distinct periods were considered: intervention and follow-up. During the intervention period patients were observed at 3-week intervals (minimum of 3 weeks and maximum of 9 weeks depending on the number of instrumental treatments performed). The required number of sessions of any of the office-based treatments (maximum of 3 sessions) was determined by clinical and anoscopy response (if after the treatment the participant scored zero points in the Sodergren scale or the anoscopy did not reveal significant hemorrhoidal disease, there was no place for additional instrumental therapy and the patient started the follow-up period.

If there was therapeutic failure at the end of the third session or if there was a significant complication (moderate or severe) the patient's participation in the study ended and he was referred for treatment with other type of office-based procedure or surgery.


Experimental: Rubber band ligation
  1. Use of reusable metal ligation device connected to a vacuum system (McGown suction method) to apply the rubber bands above the dentated line through a disposable transparent anoscope with the patient in jackknife position;
  2. A maximum of 3 sessions of ligation at 3-week intervals were performed;
  3. More than 1 band per session could be applied.
Device: Rubber band ligation

Two distinct periods were considered: intervention and follow-up. During the intervention period patients were observed at 3-week intervals (minimum of 3 weeks and maximum of 9 weeks depending on the number of instrumental treatments performed). The required number of sessions of any of the office-based treatments (maximum of 3 sessions) was determined by clinical and anoscopy response (if after the treatment the participant scored zero points in the Sodergren scale or the anoscopy did not reveal significant hemorrhoidal disease, there was no place for additional instrumental therapy and the patient started the follow-up period.

If there was therapeutic failure at the end of the third session or if there was a significant complication (moderate or severe) the patient's participation in the study ended and he was referred for treatment with other type of office-based procedure or surgery.





Primary Outcome Measures :
  1. Efficacy outcome (therapeutic success) [ Time Frame: Three to nine weeks (depending on the number of instrumental treatments performed) ]

    Achievement of therapeutic success. Classified as:

    1. Complete (Sodergren score = 0 and bleeding grade ≤ 1);
    2. Partial (Sodergren score> 0 and bleeding grade > 1 but with improvement over initial score);
    3. Therapeutic failure (participants that, at the end of three sessions of instrumental treatment, aggravated or maintained the initial Sodergren score and bleeding grade).

  2. Efficacy outcome (recurrence) [ Time Frame: One year (after the last office-based procedure) ]

    Recurrence of hemorrhoidal disease during the follow-up period (only for patients who have had some degree of therapeutic success). Classified as:

    1. Mild (Sodergren score and bleeding grade higher than the evaluation at the beginning of the follow-up period but lower than the initial ones without the need for instrumental or surgical intervention);
    2. Severe (Sodergren score and degree of hemorrhage ≥ the initial one requiring instrumental or surgical intervention).

  3. Safety outcome [ Time Frame: Three to nine weeks (depending on the number of instrumental treatments performed) ]

    Complications resulting from the office-based procedures are recorded and classified as:

    1. Mild (e.g. pain/discomfort; pruritus; bright red blood on toilet paper/cleaning pad, hemorrhoidal thrombosis requiring only medical treatment);
    2. Moderate (e.g. external hemorrhoidal thrombosis requiring surgical intervention; bright red blood that drips in the toilet or clot expulsion not requiring blood transfusion, urgent hemostasis or urgent surgery): obliges the participant to be withdrawn from the study but do not endanger the patient's life or leave long term sequelae;
    3. Severe (e.g. sepsis; Fournier's gangrene; perineal abscess; bleeding with hemodynamic instability, transfusional need or urgent surgery; sexual impotence in man): obliges the participant to be withdrawn from the study and put the patient's life at risk or implies long-term sequelae.


Secondary Outcome Measures :
  1. Efficacy outcome (number of sessions) [ Time Frame: Three to nine weeks (depending on the number of instrumental treatments performed) ]
    Number of instrumental treatment sessions required to achieve therapeutic success.

  2. Efficacy outcome (Goligher grade) [ Time Frame: Three to nine weeks (depending on the number of instrumental treatments performed) ]
    Evolution of the grade of hemorrhoidal disease (Goligher's classification).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients referred to proctologic consultation of Centro Hospitalar Universitário do Porto (CHUP) older than 18 years;
  • Clinical diagnosis of hemorrhoidal disease grade I, II and III (Goligher's classification);
  • Refractory to conservative management (dietary modification, intestinal transit modifiers, topical and phlebotonic medications) for a period of no less than 4 weeks.

Exclusion Criteria:

  • Hepatic cirrhosis;
  • Pregnant or breast-feeding women;
  • Known allergy to polidocanol
  • Another perianal disease that can cause symptoms similar to hemorrhoidal disease;
  • Concomitant presence of external hemorrhoidal disease and/or hemorrhoidal thrombosis;
  • Office-based or surgical treatment for hemorrhoids within 6 months prior to inclusion;
  • Antiplatelet or hypocoagulant medication;
  • Inherited bleeding disorders;
  • Immunosuppressive states ;
  • Inflammatory bowel disease.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04091763


Contacts
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Contact: Paulo Salgueiro, MD 00351917209020 paulosalgueiro@gmail.com

Locations
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Portugal
Centro Hospitalar Universitário do Porto Recruiting
Porto, Portugal, 4050-000
Contact: Paulo Salgueiro, MD    00351917209020    paulosalgueiro@gmail.com   
Principal Investigator: Paulo Salgueiro, MD         
Sponsors and Collaborators
Universidade do Porto
Investigators
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Principal Investigator: Paulo Salgueiro, MD Gastrenterologist

Publications:

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Responsible Party: Paulo Sérgio Durão Salgueiro, Principal Investigator, Universidade do Porto
ClinicalTrials.gov Identifier: NCT04091763     History of Changes
Other Study ID Numbers: 209117311
First Posted: September 17, 2019    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Paulo Sérgio Durão Salgueiro, Universidade do Porto:
Sclerotherapy
Rubber band ligation
Polidocanol foam
Hemorrhoidal disease
Additional relevant MeSH terms:
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Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Polidocanol
Sclerosing Solutions
Pharmaceutical Solutions