Prospective multicenter observational trial on the safety and efficacy of LEVORAG® Emulgel in the treatment of acute and chronic anal fissure

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Abstract

Background

Anal fissure (AF) is a common cause of anal pain with a tendency not to heal spontaneously because of ischemia of the anoderm caused by sphincter spasm. Lateral internal sphincterotomy, while very effective, can cause fecal incontinence and chemical sphincterotomy by application of cream may have discouraging side effects and/or low efficacy. The aim of this prospective multicenter study was to evaluate the safety and effectiveness of a new medical treatment based on Emulgel cream, with emollient, soothing and protective agents, on AF healing.

Methods

Consecutive patients with AF treated in nine coloproctology units during 6 months entered the study on topical treatment with Levorag ^® Emulgel (THD S.p.A Correggio (RE), Italy). Before treatment, they had a proctologic examination and pain was measured using a visual analog scale. THD Levorag ^® Emulgel was applied every 12 h for 40 days. Monitoring was scheduled at 10, 20 and 40 days. At time 0 and at the end of treatment, patients underwent anorectal manometry, if possible.

Results

Two hundred eighty-four AF patients were recruited (171 acute fissures). Complete healing was achieved in 47.9 % of the cases, an improvement in 31.0 % (global efficacy 78.9 %). In patients with acute fissure, the rate of efficacy was 89.4 % (complete healing: 64.3 %, improvement: 25.1 %), in those with chronic fissure the rate of efficacy was 62.8 % (complete healing: 23 %, improvement: 39.8 %), p < 0.001. Pain and resting anal pressure decreased significantly after treatment.

Conclusions

Treatment with THD Levorag ^® Emulgel proved to be effective for the reepithelization of AF and the reduction of pain in the short term in about 80 % of patients.

Related collections

Most cited references 14

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Aetiology and treatment of anal fissure.

Riikka J Lund, J Scholefield (1996)

Anal fissure is a common problem that causes significant morbidity in a young and otherwise healthy population. Treatment has remained largely unchanged for over 150 years and the pathogenesis of this condition is not yet fully explained. Acute fissure should be treated conservatively with dietary modification. Chronic fissures do not respond to conservative treatment. The current recommended surgical treatment for chronic fissure is lateral internal sphincterotomy. However, there is a disturbance of continence in a sizeable proportion of those undergoing this procedure. As yet there is no proven non-surgical treatment for chronic fissure. Although local injection of botulinum toxin and the topical application of nitrates show early promise, further controlled trials are needed.

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The management of patients with primary chronic anal fissure: a position paper

D. Altomare, G. A. Binda, S. Canuti … (2011)

Anal fissure is one of the most common and painful proctologic diseases. Its treatment has long been discussed and several different therapeutic options have been proposed. In the last decades, the understanding of its pathophysiology has led to a progressive reduction of invasive and potentially invalidating treatments in favor of conservative treatment based on anal sphincter muscle relaxation. Despite some systematic reviews and an American position statement, there is ongoing debate about the best treatment for anal fissure. This review is aimed at identifying the best treatment option drawing on evidence-based medicine and on the expert advice of 6 colorectal surgeons with extensive experience in this field in order to produce an Italian position statement for anal fissures. While there is little chance of a cure with conservative behavioral therapy, medical treatment with calcium channel blockers, diltiazem and nifepidine or glyceryl trinitrate, had a considerable success rate ranging from 50 to 90%. Use of 0.4% glyceryl trinitrate in standardized fashion seems to have the best results despite a higher percentage of headache, while the use of botulinum toxin had inconsistent results. Nonresponding patients should undergo lateral internal sphincterotomy. The risk of incontinence after this procedure seems to have been overemphasized in the past. Only a carefully selected group of patients, without anal hypertonia, could benefit from anoplasty.

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Relationship between anal pressure and anodermal blood flow. The vascular pathogenesis of anal fissures.

Boris W V Schouten, J Briel, Johannes Auwerda (1994)

The aim of this study was to investigate the relationship between anal pressure and anodermal blood flow. We performed Doppler laser flowmetry of the anoderm combined with anorectal manometry in 178 subjects (87 males and 91 females; median age, 55 (range, 17-87) years). This group consisted of 31 healthy volunteers, 23 patients with fecal incontinence, 17 patients with hemorrhoids, and 9 patients with anal fissure. The remaining 98 patients had other colorectal disorders. In 16 controls we examined anodermal blood flow in the four quadrants of the anal canal. Perfusion of the anoderm at the posterior midline was significantly lower than in the other three segments of the anal canal (posterior midline: 0.74 +/- 0.26 V; left lateral side: 1.68 +/- 0.81 V; right lateral side: 1.57 +/- 0.52 V; anterior midline: 1.48 +/- 0.69 V, P < 0.001). In the overall group, we found a significant correlation between maximum and resting pressure and anodermal blood flow at the posterior midline (r = -0.616, P < 0.001). In the nine patients with chronic anal fissure, the mean maximum anal resting pressure was 125 +/- 26 mmHg, which was significantly higher than in patients with hemorrhoids (82 +/- 15 mmHg), controls (66 +/- 19 mmHg), and patients with fecal incontinence (42 +/- 14 mmHg, P < 0.001), whereas the blood flow at the base of the fissure was significantly lower (0.43 +/- 0.10 V vs. 0.57 +/- 0.19 V vs. 0.75 +/- 0.26 vs. 1.03 +/- 0.34 V). In ten patients we also studied the influence of anesthesia on both anal pressure and anodermal blood flow. During the administration of anesthesia, anal pressure dropped from 63 +/- 21 mmHg to 32 +/- 15 mmHg (P < 0.001), whereas anodermal blood flow at the posterior midline increased from 0.79 +/- 0.22 V to 1.31 +/- 0.35 V (P < 0.001). Anodermal blood flow at the posterior midline is less than in the other segments of the anal canal. The perfusion of the anoderm at the posterior commissure is strongly related to anal pressure. The higher the pressure, the lower the flow. Our findings support the hypothesis that anal fissures are ischemic ulcers.

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Author and article information

Contributors

D. F. Altomare: +39 0805478764 , donatofrancesco.altomare@uniba.it

Journal

Journal ID (nlm-ta): Tech Coloproctol

Journal ID (iso-abbrev): Tech Coloproctol

Title: Techniques in Coloproctology

Publisher: Springer Milan (Milan )

ISSN (Print): 1123-6337

ISSN (Electronic): 1128-045X

Publication date (Electronic): 15 March 2015

Publication date PMC-release: 15 March 2015

Publication date (Print): 2015

Volume: 19

Issue: 5

Pages: 287-292

Affiliations

[ ]Department of Emergency and Organ Transplantation, University of Bari, Piazza G Cesare, 11, 70124 Bari, Italy

[ ]Department of Surgery and Oncology, Vittorio Emanuele Hospital, Catania, Italy

[ ]Department of General and Oncologic Surgery, University of Naples, Naples, Italy

[ ]Coloproctological Unit Azienda Ospedaliera “S. Anna e S. Sebastiano” di Caserta, Caserta, Italy

[ ]Department of General Surgery, Ospedale Ignazio Veris Delli Ponti, Scorrano, Italy

[ ]Department of Surgery, IRCCS De Bellis, Castellana Grotte, Bari, Italy

[ ]Department of General Surgery, University of Catania, Policlinico G. Rodolico, Catania, Italy

[ ]Department of General Surgery, Brotzu Hospital, Cagliari, Italy

[ ]Colonproctology Unit, Garibaldi-Nesima Hospital, University of Catania, Catania, Italy

Article

Publisher ID: 1289

DOI: 10.1007/s10151-015-1289-2

PMC ID: 4555206

PubMed ID: 25772685

SO-VID: ee1df241-4b50-4287-a588-95fe636fd0c6

License:

Open AccessThis article is distributed under the terms of the Creative Commons Attribution License which permits any use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited.

History

Date received : 30 November 2014

Date accepted : 10 February 2015

Custom metadata

ScienceOpen disciplines: Gastroenterology & Hepatology

Keywords: anal fissure,emulgel cream,chemical sphincterotomy

Data availability:

ScienceOpen disciplines: Gastroenterology & Hepatology

Keywords: anal fissure, emulgel cream, chemical sphincterotomy

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