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Clinical Trial
Journal Article
Multicenter Study
Doppler-guided hemorrhoidal dearterialization with laser (HeLP): a prospective analysis of data from a multicenter trial.
Techniques in Coloproctology 2018 August
BACKGROUND: Doppler-guided hemorrhoidal laser procedure (HeLP) is a new minimally invasive technique to treat symptomatic hemorrhoids. The aim of this multicenter study was to prospectively assess clinical results and patients' satisfaction in patients treated with HeLP.
METHODS: Indications for HeLP included patients with symptomatic hemorrhoids resistant to medical therapy, with low-grade prolapse. Clinical efficacy was evaluated assessing resolution of symptoms and patient satisfaction. Frequency of bleeding and frequency of acute hemorrhoid-related symptoms were given a score of 0 to 4 (where 4 = more than 3 episodes/week) and 0 to 3 (where 3 = more than 5 episodes/year), respectively. Quality of life, pain at rest, and pain with evacuation were scored using a visual analogue scale (VAS) of 0 to 10. Intra- and postoperative complications were recorded. Potential predictive factors for failure were assessed.
RESULTS: Two hundred and eighty-four patients (183 males, 101 females) with a mean age of 47.5 years were included in the study. At 6-month follow-up, symptoms had completely resolved in 257/284 (90.5%) and 275/284 (96.8%) patients were satisfied with the results. An analysis of a subgroup of 144 patients followed up for a minimum of 12 months revealed a resolution of symptoms in 130/144 (90.3%) and satisfaction in 139/144 (96.5%). There was a statistically significant improvement of the bleeding score (from 2.4 ± 1.07 to 0.36 ± 0.49; p < 0.0001), acute symptoms score (from 2.03 ± 0.16 to 0.61 ± 0.59; p < 0.0001), quality of life (from 4.63 ± 1.32 to 8.96 ± 1.35; p < 0.0001), pain at rest (from 3.0 ± 2.05 to 1.1 ± 0.99; p < 0.0006), and pain with evacuation (from 4.8 ± 1.22 to 1.7 ± 1.15; p < 0.0001). No significant changes in continence and constipation were observed. Univariate analysis failed to show factors significantly associated with failure.
CONCLUSIONS: The HeLP procedure seems to be safe and effective in patients with symptomatic hemorrhoids. It is simple, minimally invasive, and relatively pain free. It can be performed in an ambulatory setting without anesthesia, and it achieves high patient satisfaction. It may, therefore, be considered a "first-line treatment" in all patients without significant hemorrhoidal prolapse in whom medical therapy has failed.
METHODS: Indications for HeLP included patients with symptomatic hemorrhoids resistant to medical therapy, with low-grade prolapse. Clinical efficacy was evaluated assessing resolution of symptoms and patient satisfaction. Frequency of bleeding and frequency of acute hemorrhoid-related symptoms were given a score of 0 to 4 (where 4 = more than 3 episodes/week) and 0 to 3 (where 3 = more than 5 episodes/year), respectively. Quality of life, pain at rest, and pain with evacuation were scored using a visual analogue scale (VAS) of 0 to 10. Intra- and postoperative complications were recorded. Potential predictive factors for failure were assessed.
RESULTS: Two hundred and eighty-four patients (183 males, 101 females) with a mean age of 47.5 years were included in the study. At 6-month follow-up, symptoms had completely resolved in 257/284 (90.5%) and 275/284 (96.8%) patients were satisfied with the results. An analysis of a subgroup of 144 patients followed up for a minimum of 12 months revealed a resolution of symptoms in 130/144 (90.3%) and satisfaction in 139/144 (96.5%). There was a statistically significant improvement of the bleeding score (from 2.4 ± 1.07 to 0.36 ± 0.49; p < 0.0001), acute symptoms score (from 2.03 ± 0.16 to 0.61 ± 0.59; p < 0.0001), quality of life (from 4.63 ± 1.32 to 8.96 ± 1.35; p < 0.0001), pain at rest (from 3.0 ± 2.05 to 1.1 ± 0.99; p < 0.0006), and pain with evacuation (from 4.8 ± 1.22 to 1.7 ± 1.15; p < 0.0001). No significant changes in continence and constipation were observed. Univariate analysis failed to show factors significantly associated with failure.
CONCLUSIONS: The HeLP procedure seems to be safe and effective in patients with symptomatic hemorrhoids. It is simple, minimally invasive, and relatively pain free. It can be performed in an ambulatory setting without anesthesia, and it achieves high patient satisfaction. It may, therefore, be considered a "first-line treatment" in all patients without significant hemorrhoidal prolapse in whom medical therapy has failed.
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