Flavonoids mixture (diosmin, troxerutin, hesperidin) in the treatment of acute hemorrhoidal disease: a prospective, randomized, triple-blind, controlled trial.

BACKGROUND: The role of a mixture of phlebotonics in the treatment of acute hemorrhoid crisis is investigated to test their efficacy. METHODS: One hundred and thirty-four consecutive patients with an acute hemorrhoidal crisis recruited in five colorectal units entered the study. Sixty-six of them were randomized to receive a mixture of diosmin, troxerutin and hesperidin (group A), and 68 a placebo (group B). The main symptoms, the use of oral painkillers and the Bristol scale score were recorded at each scheduled visit and compared using both Student's t test for independent samples and the ANOVA models for repeated measures. The presence of edema, prolapse and thrombosis were also recorded and compared using the Chi-square test. Furthermore, the trend of proportions during the time of the evaluations was assessed by the Chi-square test for linear trend. RESULTS: Pain, bleeding and the proportion of patients who reported persistence of edema and thrombosis decreased significantly after 12 days of treatment in group A. After 6 days, the number of paracetamol tablets taken by patients in group A was significantly lower than the amount of flavonoid mixture. CONCLUSIONS: The use of a mixture of diosmin, troxerutin and hesperidin is a safe and effective mean of managing symptoms of acute hemorrhoidal disease. Furthermore, in patients receiving treatment, there was faster control and lower persistence of edema and thrombosis.

Seton or glue for trans-sphincteric anal fistulae: a prospective randomized crossover clinical trial.

OBJECTIVE: Fibrin glue treatment of anal fistulae has been proposed to minimize the risk of faecal incontinence but its acceptance by coloproctologists is still poor because the published data is controversial. Therefore, we carried out a prospective randomized crossover trial comparing treatment with a commercial fibrin glue to classical seton treatment, with healing rate, hospital stay, healing time, faecal incontinence and postoperative pain as study outcomes. METHOD: Sixty-four homogeneous patients with trans-sphincteric anal fistulae referred to seven colorectal units were randomized to undergo fibrin glue (39 patients) or seton (25 patients) treatment. Patients failing to heal after treatment with fibrin glue were re-randomized to undergo a second injection with glue or seton treatment. RESULTS: Sixty-two of the 64 patients completed the minimum 1-year follow-up period. Twenty-one of 24 patients healed in the seton group compared with 15/38 in the fibrin glue group (P = 0.0007). The 23 failures after glue treatment were re-randomized to have a second glue injection (eight patients) or a seton treatment (15 patients). Four of the eight (50%) patients treated with a second injection of glue, and nine out of the 15 (60%) patients in the seton group, healed. Patients treated with fibrin glue reported less postoperative pain and had a shorter hospital stay than patients treated with a seton; furthermore, faecal continence and anal manometry significantly worsened after seton treatment. CONCLUSION: Seton treatment has a significantly higher probability of success compared with fibrin glue treatment but poses a higher risk of faecal incontinence. Fibrin glue could be considered as a first line of treatment for patients at risk of faecal incontinence or other comorbidities.

Ligasure Precise vs. conventional diathermy for Milligan-Morgan hemorrhoidectomy: a prospective, randomized, multicenter trial.

PURPOSE: Milligan-Morgan hemorrhoidectomy using radiofrequency dissection (Ligasure) has been proposed instead of conventional diathermy in view of its potential benefits in terms of postoperative anal pain and better hemostatic control, but the medical literature is still controversial. This multicenter, randomized, controlled trial was designed to compare the outcomes between Ligasure and conventional diathermy hemorrhoidectomy in the Milligan-Morgan procedures in a sufficient number of patients. METHODS: Patients with Grades III and IV hemorrhoids were randomized to two groups: Ligasure hemorrhoidectomy and conventional diathermy. Postoperative anal pain was measured by the Visual Analog Scale (VAS) and the analgesia required. Postoperative complications, wound healing, and return to working activities also were evaluated as secondary outcomes. RESULTS: A total of 273 patients, well matched for age, gender, working activity and grade of hemorrhoids, were randomized to two groups: Ligasure 146, and diathermy 127. The severity of postoperative anal pain was significantly less in the Ligasure group when measured at least 12 hours after defecation (P < 0.01), whereas it was similar at the time of defecation. The Ligasure group had significantly lower requirements for painkiller pills. There were no significant differences in early and late complications. Return to work and normal activities was significantly faster in the Ligasure group. CONCLUSION: Ligasure hemorrhoidectomy is an effective procedure for Grades III and IV hemorrhoids and facilitates a faster return to work and normal activities by reducing postoperative pain.

Anal endosonography: a survey of equipment, technique and diagnostic criteria adopted in nine Italian centers.

BACKGROUND: Anal endosonography (AES) has become an essential part of the pre-operative diagnostic workup in both organic and functional anal diseases. METHODS: Nine Italian centres with an average volume activity of >10 exams/week each were surveyed with the aim of determining the concordance with respect to indications for the procedure and interpretation of the results. RESULTS: Overall, anal sepsis, faecal incontinence and anorectal tumours were the more common indications for AES while evacuation dysfunctions and anal pain were not always considered indications. All centres use the same diagnostic criteria for simple and complicated perirectal sepsis and sphincteric defects, but adopt different classifications for stage 1 and stage 2 anal tumours. Participants agreed in that lymph-node staging by AES is less precise than tumour staging, especially after chemoradiation therapy. CONCLUSIONS: A list of recommendations and guidelines based on the groups's experience has been produced for those radiologists and coloproctologists interested in the use of AES and accreditation of their centres.