ArticleFrontiers in surgery2026
Evaluating the effectiveness of oral phlebotonics for the conservative management of hemorrhoidal disease: insights from the VIVI2022/01/VIVALDI study.
Article in Frontiers in surgery, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07376928 (Multicenter Prospective Real-world Observational Study to Evaluate the Effectiveness of Phlebotonics, as Conservative Therapy in a Cohort of Patients With Symptomatic Hemorrhoidal Disease), which is not on this map. Not yet cited in PubMed.
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Multicenter Prospective Real-world Observational Study to Evaluate the Effectiveness of Phlebotonics, as Conservative Therapy in a Cohort of Patients With Symptomatic Hemorrhoidal Disease (HD) of I, II or III Goligher Grade
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10 authors.
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Abstract
Background: The aim of this study is to describe the baseline characteristics of an Italian, real-world cohort of patients with symptomatic hemorrhoidal disease (HD) and to evaluate the effectiveness and safety of phlebotonic drugs, in addition to standard of care. Methods: This is a prospective, multicenter, observational cohort study (VIVI2022/01/VIVALDI, ClinicalTrials.gov number: NCT07376928) on adults with symptomatic Goligher grade I-II-III HD. The primary endpoint was the improvement in the hemorrhoidal disease symptom score (HDSS). Secondary endpoints were based on the resolution of bleeding (Giamundo score), improvement in quality of life (Short Health Scale adapted for HD), Goligher grading, Single Pile Hemorrhoid Classification (SPHC), adverse events, satisfaction with treatment, and change in treatment strategy during the 30-day observational period. Patients were evaluated by visits and questionnaires at baseline and after 30 days; at day 30, the evaluation also included the assessment of surgical indication. At day 15, patients were also interviewed through a phone call in order to verify adherence and unexpected effects. Results: A total of 115 patients (70% male), with a mean (SD) age of 51.4 years and HD diagnosed since an average of 4.6 (8.3) years, were enrolled. The mean HDSS decreased from 7.8 (3.6) at baseline to 3.7 (2.6) at day 30 ( Conclusion: A 30-day course of conservative therapy with oral phlebotonics was found to be safe and effective in improving a variety of clinical measures in adults with symptomatic Goligher grade I-II-III HD.
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