Doppler-guided hemorrhoidal dearterialization with laser (HeLP): indications and clinical outcome in the long-term. Results of a multicenter trial.

Background: Doppler-guided hemorrhoidal laser procedure consists of sutureless closure of terminal branches of the superior hemorrhoidal artery by laser energy. Clinical results of patients treated with this procedure were analyzed at the completion of 2-year follow-up. Primary endpoint was resolution of symptoms and secondary endpoints were recurrence rate, type of recurrences, re-operation rate, and potential predictive factors for failure.

Methods: Bleeding was assessed on a score from 0 to 4 (none = 0; < 1/month = 1; 1/week = 2; > 1/week = 3; 3-4/week = 4), frequency of hemorrhoid-related symptoms with a score of 0-3 (2/year = 1; 3-5/year = 2; < 5/year = 3). Constipation and fecal incontinence were assessed by means of validated scores. Quality of life and pain at defecation were assessed using a visual analog scale of 0-10 (0 = worst possible-10 = best possible quality of life and 0 = no pain-10 = worst pain imaginable, respectively). Recurrence rate and need for re-operation were reported. Potential predictive factors of failure were analyzed by means of univariate analysis.

Results: Two-hundred-eighty-four patients (183 males, 101 females; mean age: 47.5 years) were included in the trial; 8 patients were lost at follow-up. Analysis of 276 patients who completed the 2-year follow-up showed an overall resolution of symptoms in 89.9% (248/276) of patients. Statistically significant improvement of quality of life, pain reduction, bleeding and frequency of acute symptoms were reported. Of 28 patients with persistent or recurrent symptoms, 12 had pain (4.35%), 10 had bleeding (3.6%) and 6 had increasing prolapse at defecation (2.2%). Eleven out of twenty-eight patients required additional surgery. Constipation and III-IV grade hemorrhoids were associated with statistically significant higher failure rates (p = 0.046 and 0.012, respectively). Better results were reported in patients reporting preoperative high-grade pain at evacuation.

Conclusions: The Doppler-guided hemorrhoidal laser procedure showed efficacy at long-term follow-up. It can be considered as 'first-line' treatment in patients with low-grade hemorrhoids suffering from bleeding, pain and recurrent acute symptoms in whom conservative treatment failed.