Sclerotherapy With Polidocanol Foam Versus Rubber Band Ligation in the Treatment of First, Second and Third-Grade Hemorrhoidal Disease: a Randomized, Controlled Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Universidade do Porto
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Efficacy outcome (therapeutic success)
Study Overview
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.
Detailed Description
INTRODUCTION Hemorrhoids are normal vascular structures in the anal canal, arising from a cushion of dilated arteriovenous channels and connective tissues, that drains into the superior and inferior hemorrhoidal veins. Their main function is to maintain anal continence, serve as a protection for the anal sphincters during the act of defecation and have a sensory function, allowing to differentiate liquids, solids or gases and to signal defecation.
The hemorrhoidal disease develops when the supporting tissues of hemorrhoidal cushions deteriorate due to various processes: abnormal venous dilation, vascular thrombosis, degenerative processes of collagen and fibroelastic tissue, distortion and rupture of anal subepithelial muscle, hyperperfusion of the hemorrhoidal plexus, inflammatory phenomena and hormonal changes (typical of pregnancy).
Hemorrhoidal disease occurs frequently in the adult population and a considerable number of patients are asymptomatic. Both sexes are similarly affected. The peak incidence occurs between 45-65 years, being rare before the age of 20.
Classification of hemorrhoidal disease corresponds to its position relative to the dentate line. External hemorrhoids are located below the dentate line and are covered by modified squamous epithelium, being richly innervated and therefore painful when there is associated thrombosis. On the contrary, internal hemorrhoids lie above the dentate line. Internal hemorrhoids are further classified based on their appearance and degree of prolapse according to the Goligher classification: grade I, without prolapse (they have the potential to bleed but are not visualized without the aid of an anoscope); grade II, prolapsed with defecation, but reduced spontaneously; grade III, prolapse with defecation requiring manual reduction and grade IV, prolapsed and non-reducible.
Since hemorrhoidal disease is a benign pathology, its treatment should be guided by the symptoms and the impact of the disease on quality of life. A prospective study by Pucher et al. developed and validated the Sodergren scale, which is based on a set of symptoms to assess the severity of hemorrhoidal disease. This scale can be used to assess the efficacy of treatment of haemorrhoids and the comparison of trials, consequently it is helpful in the choice of the best therapeutic option.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Polidocanol foam sclerotherapy
- Preparation of the polidocanol foam according to Tessari technique immediately before application (so that the "microbubbles" of the foam did not disintegrate);
- 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;
- Patients treated in a maximum of 3 sessions at 3 weeks intervals;
- Maximum dose per treatment session of 20mL of mixture of 4mL of polidocanol 3% with 16mL of air;
- In each session more than one hemorrhoid cushion could be treated.
Intervention: Polidocanol Injectable Foam (Drug)
Rubber band ligation
- 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;
- A maximum of 3 sessions of ligation at 3-week intervals were performed;
- More than 1 band per session could be applied.
Intervention: Rubber band ligation (Device)
Outcomes
Primary Outcomes
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).
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).
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 Outcomes
- 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))
Investigators
Paulo Sérgio Durão Salgueiro
Principal Investigator
Universidade do Porto