THERESA-3 Study

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 220

Inclusion Criteria

Fulfillment of the diagnostic criteria (there will be considered eligible all patients of both sexes with a clinical diagnosis of acute hemorrhoids characterized by anal pain of sudden onset, with tumors of variable size and appearance, and may be colored red-violet, usually associated with a significant edema). Aged between 18 and 75 years, inclusive. Voluntary patient signing the informed consent.

Exclusion Criteria

History of intracranial hemorrhage. History of cerebrovascular disease, intracranial surgery or head trauma <3 months. Digestive or urinary bleeding <21 days. Recent surgery <14 days. Recent serious trauma <4 weeks. Puncture of major vessels no compressible in the last 7 days. Treatment with anticoagulant pharmaceuticals. Active internal bleeding (<3 weeks) or other conditions where there is significant risk of bleeding or would be difficult to manage because of its location. History of severe arterial hypertension or ventricular tachycardia. History of hereditary coagulopathy (factor VIII deficiency [classic hemophilia] and IX [Christmas disease] of clotting). Decompensated chronic disease (diabetes mellitus, heart insufficiency, and hyperthyroidism). Peripheral or mesenteric vascular thrombosis. Difficulty in secondary urination due to prostatic hyperplasia. Hemorrhoidal disease caused by portal hypertension. Hemorrhoidal disease associated with abscess, fistula or cancer. Hemorrhoidal disease with septic complications or active hemorrhage. Acute diarrheal disease in the last 12 hours. Administration of Streptokinase in the preceding 6 months. History of allergy to Streptokinase, Thiomersal or Salicylates (including aspirin), Phenylephrine, or any ingredient of the formulations under study. Pregnancy or lactation. Obvious mental incapacity to give consent, and act accordingly to the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical response at the 5th day after starting treatment, according to the following criteria: TOTAL Response: Complete disappearance of pain and edema (or mild intensity), and reduction of 70% or more of the initial size of the hemorrhoidal lesion. PARTIAL Response: Presence of pain and edema but with reduced intensity, and 50 - 69% reduction of the size of the lesion. No RESPONSE: No reduction in pain intensity and / or edema, and reduction of less than 50% of the hemorrhoidal lesion.

Secondary Outcome Measures

Name	Time	Method
Clinical response at 72 hours and at the 10th day after starting treatment. Edema, the presence or not will assess through direct physical examination (inspection) of the region. Pain, measured using the same intensity criteria used to assess the adverse events (mild, moderate or severe). Size of the lesion; it is an indirect measure and more objective of the development of edema; for this the patient will be placed in prone position with exposure of the anal part and will be measured (ruler in millimeters) in centimeters (at the inclusion, and at 5 and 10 days after starting treatment) the largest horizontal and vertical diameters of the lesion. Need for surgery (yes/no) at the 10th day after starting treatment