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.

Optimal treatment duration of glyceryl trinitrate for chronic anal fissure: results of a prospective randomized multicenter trial.

BACKGROUND: Chronic anal fissure (CAF) is a painful condition that is unlikely to resolve with conventional conservative management. Previous studies have reported that topical treatment of CAF with glyceryl trinitrate (GTN) reduces pain and promotes healing, but optimal treatment duration is unknown. METHODS: To assess the effect of different treatment durations on CAF, we designed a prospective randomized trial comparing 40 versus 80 days with twice daily topical 0.4% GTN treatment (Rectogesic, Prostrakan Group). Chronicity was defined by the presence of both morphological (fibrosis, skin tag, exposed sphincter, hypertrophied anal papilla) and time criteria (symptoms present for more than 2 months or pain of less duration but similar episodes in the past). A gravity score (1 = no visible sphincter; 2 = visible sphincter; 3 = visible sphincter and fibrosis) was used at baseline. Fissure healing, the primary endpoint of the study, maximum pain at defecation measured with VAS and maximum anal resting pressure were assessed at baseline and at 14, 28, 40 and 80 days. Data was gathered at the end of the assigned treatment. RESULTS: Of 188 patients with chronic fissure, 96 were randomized to the 40-day group and 92 to the 80-day group. Patients were well matched for sex, age, VAS and fissure score. There were 34 (19%) patients who did not complete treatment, 18 (10%) because of side effects. Of 154 patients who completed treatment, 90 (58%) had their fissures healed and 105 (68%) were pain free. There was no difference in healing or symptoms between the 40- and the 80-day group. There was no predictor of fissure healing. A low fissure gravity score correlated with increased resolution of pain (P < 0.05) and improvement of VAS score (P < 0.05) on both univariate and multivariate analysis. A lower baseline resting pressure was associated with better pain resolution on univariate analysis (P < 0.01). VAS at defecation and fissure healing significantly improved until 40 days (P < 0.001), while the difference between 40 and 80 days was not significant. CONCLUSION: We found no benefits in treating CAF with topical GTN for 80 days compared to 40 days. Fissure healing and VAS improvement continue until 6 weeks of treatment but are unlikely thereafter.

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.

Glyceryl trinitrate for chronic anal fissure--healing or headache? Results of a multicenter, randomized, placebo-controled, double-blind trial.

PURPOSE: Internal anal sphincterotomy for treating chronic anal fissure can irreversibly damage anal continence. Reversible chemical sphincterotomy may be achieved by anal application of glyceryl trinitrate ointment (nitric oxide donor), which has been reported to heal the majority of patients with anal fissure by inducing sphincter relaxation and improving anodermal blood flow. This trial aimed to further clarify the role of glyceryl trinitrate in the treatment of chronic anal fissure. METHODS: A total of 132 consecutive patients from nine centers were randomly assigned to receive 0.2 percent glyceryl trinitrate ointment or placebo twice daily for at least four weeks. The severity of pain and maximum anal resting pressure were measured before and after one week of treatment. Anodermal blood flow was measured before and after application of glyceryl trinitrate or placebo in ten patients. RESULTS: The study was completed by 119 patients (59 glyceryl trinitrate and 60 placebo), matched for gender, age, duration of symptoms, duration of treatment, site of fissure, previous attempts to treat, pain score, and maximum anal resting pressure. Twenty-nine patients (49.2 percent) healed after glyceryl trinitrate and 31 patients (51.7 percent) healed after placebo (P = not significant). Pain score fell significantly in both groups, in addition to maximum anal resting pressure. Anodermal blood flow improved significantly in seven patients receiving glyceryl trinitrate, but not in the three receiving placebo. Twenty-three patients (33.8 percent) experienced headache and 4 (5.9 percent), orthostatic hypotension after glyceryl trinitrate. CONCLUSION: This trial fails to demonstrate any superiority of topical 0.2 percent glyceryl trinitrate treatment vs. a placebo, although the effects of glyceryl trinitrate on anodermal blood flow and sphincter pressure are confirmed. This finding, together with the high incidence of side-effects, should discourage the use of this treatment as a substitute for surgery in chronic anal fissure.

Management of perianal Crohn's disease. Results of a multicenter study in Italy.

PURPOSE: Management of perianal Crohn's disease is still controversial, and reports on large series are very few in the literature. The aim of this multicenter study was to investigate the outcome of both medical and surgical treatment in 225 patients. METHODS: Patients cared for at different institutions were followed up for a median of six years. Most of them had either anal fistula or an abscess (86 percent and 43 percent, respectively), but fissures were also present in 26 percent of the cases. Diarrhea and anal pain were the most common symptoms. Anal lesions preceded the onset of intestinal symptoms in 19 percent of cases. RESULTS: Medical treatment was curative only in 21 of 123 patients. Overall, medical and surgical treatment either cured or improved 62 percent of the cases. Fifty percent had an intestinal resection. Abscess drainage and fistulotomy were the most common anal surgeries. Rectovaginal fistulas (n = 30) required intestinal surgery in 36 percent and anal surgery in 20 percent of the cases, 50 percent with good results. Of 166 patients who had anal surgery, 97 (58 percent) had a positive outcome. Recurrence of anal disease requiring further surgery occurred in 24.5 percent of the cases. CONCLUSIONS: Limited surgeries seem to achieve satisfactory results in more than one-half of the patients affected by perianal Crohn's lesions, whereas medical treatment alone is curative in a small portion of them.