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

NCT04091763 | Completed Phase 2

• 1 other identifier: 209117311
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemorrhoids, Internal

Keywords

Sclerotherapy; Rubber band ligation; Polidocanol foam; Hemorrhoidal disease

Outcome Measures

Primary Outcomes (3)

• Efficacy outcome (therapeutic success)

  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).

  Three to nine weeks (depending on the number of instrumental treatments performed)

• Efficacy outcome (recurrence)

  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).

  One year (after the last office-based procedure)

• Safety outcome

  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.

  Three to nine weeks (depending on the number of instrumental treatments performed)

Secondary Outcomes (2)

• Efficacy outcome (number of sessions)

  Three to nine weeks (depending on the number of instrumental treatments performed)

• Efficacy outcome (Goligher grade)

  Three to nine weeks (depending on the number of instrumental treatments performed)

Study Arms (2)

Polidocanol foam sclerotherapy

EXPERIMENTAL

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

Rubber band ligation

EXPERIMENTAL

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

Interventions

Polidocanol Injectable Foam DRUG

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.

Polidocanol foam sclerotherapy

Rubber band ligation DEVICE

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.

Rubber band ligation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Antiplatelet or hypocoagulant medication;
• Inherited bleeding disorders;
• Immunosuppressive states ;
• Inflammatory bowel disease.

Sponsors & Collaborators

• Universidade do Porto: lead

Study Sites (1)

Centro Hospitalar Universitário do Porto

Porto, 4050-000, Portugal

Location

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MeSH Terms

Conditions

Hemorrhoids

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Paulo Salgueiro, MD

  Gastrenterologist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomly assigned to either rubber band ligation or sclerotherapy with polidocanol foam, stratified by grade of hemorrhoidal disease

Study Record Dates

• First Submitted: September 4, 2019
• First Posted: September 17, 2019
• Study Start: August 1, 2018
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: August 21, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)