Esfinterotomía quirúrgica (esfinterotomía lateral interna cerrada) frente a química (toxina botulínica) en el tratamiento de la fisura anal crónica
Surgical (close lateral internal sphincterotomy) versus chemical (botulinum toxin) sphincterotomy as treatment of chronic anal fissure
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Biological significance and clinical utility" ] ] "contieneTextoCompleto" => array:1 [ "es" => true ] "contienePdf" => array:1 [ "es" => true ] "autores" => array:1 [ 0 => array:2 [ "autoresLista" => "José Luis Pérez Arellano, Alfonso Ángel-Moreno Maroto" "autores" => array:2 [ 0 => array:2 [ "nombre" => "José Luis" "apellidos" => "Pérez Arellano" ] 1 => array:2 [ "nombre" => "Alfonso" "apellidos" => "Ángel-Moreno Maroto" ] ] ] ] ] "idiomaDefecto" => "es" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/13074138?idApp=UINPBA00004N" "url" => "/00257753/0000012400000015/v0_201307292009/13074138/v0_201307292010/es/main.assets" ] "itemAnterior" => array:16 [ "pii" => "13074136" "issn" => "00257753" "doi" => "10.1157/13074136" "estado" => "S300" "fechaPublicacion" => "2005-04-23" "documento" => "article" "crossmark" => 0 "subdocumento" => "fla" "cita" => "Med Clin. 2005;124:571-2" "abierto" => array:3 [ "ES" => false "ES2" => false "LATM" => false ] "gratuito" => false "lecturas" => array:2 [ "total" => 6360 "formatos" => array:3 [ "EPUB" => 7 "HTML" => 5829 "PDF" => 524 ] ] "es" => array:12 [ "idiomaDefecto" => true "titulo" => "Anorexia nerviosa y atrofia cerebral en adolescentes" "tienePdf" => "es" "tieneTextoCompleto" => "es" "tieneResumen" => array:2 [ 0 => "es" 1 => "en" ] "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "571" "paginaFinal" => "572" ] ] "titulosAlternativos" => array:1 [ "en" => array:1 [ "titulo" => "Anorexia nervosa and cerebral atrophy in adolescents" ] ] "contieneResumen" => array:2 [ "es" => true "en" => true ] "contieneTextoCompleto" => array:1 [ "es" => true ] "contienePdf" => array:1 [ "es" => true ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:8 [ "identificador" => "fig1" "etiqueta" => "Fig. 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "copyright" => "Elsevier España" "figura" => array:1 [ 0 => array:4 [ "imagen" => "2v124n15-13074136fig02.jpg" "Alto" => 803 "Ancho" => 737 "Tamanyo" => 116732 ] ] "descripcion" => array:1 [ "es" => "Resonancia magnética en T1 (A) y T2 (B) del caso 2, que presentaba atrofia cerebral. Se aprecia un aumento de tamaño y del número de surcos de la convexidad." ] ] ] "autores" => array:1 [ 0 => array:2 [ "autoresLista" => "Jesús Fleta Zaragozano, África Jiménez Vidal, Mariano Velilla Picazo, Gema González Castro, Ignacio Pina Leita, José Luis Olivares López" "autores" => array:6 [ 0 => array:2 [ "nombre" => "Jesús" "apellidos" => "Fleta Zaragozano" ] 1 => array:2 [ "nombre" => "África" "apellidos" => "Jiménez Vidal" ] 2 => array:2 [ "nombre" => "Mariano" "apellidos" => "Velilla Picazo" ] 3 => array:2 [ "nombre" => "Gema" "apellidos" => "González Castro" ] 4 => array:2 [ "nombre" => "Ignacio" "apellidos" => "Pina Leita" ] 5 => array:2 [ "nombre" => "José Luis" "apellidos" => "Olivares López" ] ] ] ] ] "idiomaDefecto" => "es" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/13074136?idApp=UINPBA00004N" "url" => "/00257753/0000012400000015/v0_201307292009/13074136/v0_201307292009/es/main.assets" ] "en" => array:14 [ "idiomaDefecto" => true "titulo" => "Esfinterotomía quirúrgica (esfinterotomía lateral interna cerrada) frente a química (toxina botulínica) en el tratamiento de la fisura anal crónica" "tieneTextoCompleto" => true "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "573" "paginaFinal" => "575" ] ] "autores" => array:1 [ 0 => array:3 [ "autoresLista" => "Antonio Arroyo Sebastián, Francisco Pérez Vicente, Elena Miranda Tauler, Ana Sánchez Romero, Pilar Serrano Paz, Rafael Calpena Rico" "autores" => array:6 [ 0 => array:3 [ "nombre" => "Antonio" "apellidos" => "Arroyo Sebastián" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "affa" ] ] ] 1 => array:3 [ "nombre" => "Francisco" "apellidos" => "Pérez Vicente" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "affa" ] ] ] 2 => array:3 [ "nombre" => "Elena" "apellidos" => "Miranda Tauler" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "affa" ] ] ] 3 => array:3 [ "nombre" => "Ana" "apellidos" => "Sánchez Romero" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "affa" ] ] ] 4 => array:3 [ "nombre" => "Pilar" "apellidos" => "Serrano Paz" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "affa" ] ] ] 5 => array:3 [ "nombre" => "Rafael" "apellidos" => "Calpena Rico" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "affa" ] ] ] ] "afiliaciones" => array:1 [ 0 => array:3 [ "entidad" => "Unidad de Coloproctología. Servicio Cirugía General y Aparato Digestivo. Hospital General Universitario de Elche. Elche. Alicante. Spain." "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "affa" ] ] ] ] "titulosAlternativos" => array:1 [ "en" => array:1 [ "titulo" => "Surgical (close lateral internal sphincterotomy) versus chemical (botulinum toxin) sphincterotomy as treatment of chronic anal fissure" ] ] "textoCompleto" => "<p class="elsevierStylePara">Anal fissure remains one of the most common proctologic problems, which manifests as pain and bleeding on defecation. Chronic anal fissures are associated with persistent hypertonia of the internal anal sphincter<span class="elsevierStyleSup">1</span>. For this reason, a variety of surgical methods<span class="elsevierStyleSup">2</span> have been described in order to eliminate the spasm and decrease elevated anal pressures, thereby allowing the fissure to heal.</p><p class="elsevierStylePara">Lateral internal sphincterotomy<span class="elsevierStyleSup">2</span> has been widely accepted as the treatment of choice for chronic anal fissures, resulting in healing in over 90% of patients. However, the high rates of incontinence (0-66%)<span class="elsevierStyleSup">3</span> reported in surgical sphincterotomy have led to the study and implementation of other alternative medical treatments, mainly botulinum toxin (BT)<span class="elsevierStyleSup">4-9</span> and organic nitrate preparations<span class="elsevierStyleSup">4</span> that produce reversible reduction in sphincter pressure, hence allowing the anal fissure to heal. In comparative studies<span class="elsevierStyleSup">4</span>, BT has achieved lower rates of recurrence (4% vs 40%) with the fewest side effects (0 vs 20%) when compared with the results reported for nitrate preparations.</p><p class="elsevierStylePara">Thus, the aim of this prospective randomized controlled trial was to compare the effectiveness and morbidity of surgical (ambulatory close lateral internal sphincterotomy performed with local anaesthesia) and chemical (BT) sphincterotomy in the treatment of chronic anal fissure.</p><p class="elsevierStylePara">Patients and method</p><p class="elsevierStylePara">Between January 1998 and January 2000, 80 patients with chronic anal fissure were randomized according to a computer randomization program to surgical sphincterotomy (group 1, n = 40) or chemical sphincterotomy with botulinum toxin (group 2, n = 40). This study (first visit, sphincterotomy and postoperative revision) was done in an ambulatory setting in the Coloproctology Unit of Elche University Hospital. The study was approved by the ethics committee and each patient signed the informed consent before participating in the study.</p><p class="elsevierStylePara">First, all patients were diagnosed as having chronic anal fissure based on their medical history and physical examination, and were treated for a minimum of 6 weeks with conservative medical treatment (high residue diet, analgesics, and warm sitz baths) before definitive definition of chronic anal fissure and inclusion in the study. Chronic anal fissure was defined as the presence of a fibrous induration or exposed internal sphincter fibres.</p><p class="elsevierStylePara">Exclusion criteria were: associated anal pathologies (stenosis, abscess, fistula and hemorrhoids), patients with associated conditions (inflammatory bowel disease, acquired immunodeficiency syndrome, tuberculosis, sexually transmitted disease and immunosuppression), anticoagulation therapy, allergy to local anaesthetics and pregnancy.</p><p class="elsevierStylePara">All patients were treated by the same surgeon using a uniform method in the prone jackknife position. All patients had a pulse oxymeter monitor and did not need preoperative laboratory tests, enema preparation, antibiotics or intravenous access.</p><p class="elsevierStylePara">Close lateral internal sphincterotomy was carried out under local anaesthesia (20 ml mepivacaine 2%) using a 25 G needle. The anaesthetic was injected into the skin, intersphincteric plane, internal sphincter and submucosa on the right and left side. The fissure furrow was also infiltrated. The sphincterotomy was performed by inserting #11 scalpel blade through the anoderm, advancing towards the intersphinteric plane. The cutting edge was rotated 90º, and a partial internal sphincterotomy was completed up to the dentate line. The skin incision was not closed and a direct pressure was applied for 5 minutes.</p><p class="elsevierStylePara">In the chemical sphincterotomy group, 100-U vials of type A lyophilized botulinum (BOTOX, Allergan, Inc., Irvine, CA, USA) were stored at a temperature of ­20 ºC and diluted in saline to 0.1 ml/2.5 U the day of injection. With a 25 G needle, a total of 25 U were injected into the internal sphincter guided under direct vision and digital examination (8-U dose into each lateral side of the sphincter and 9-U into the anterior verge).</p><p class="elsevierStylePara">In both groups, patients were discharged with instructions concerning high residue diet, analgesics (oral metanizol 1 capsule [575 mg]/8 h alternating with oral ketorolac 1 capsule [10 mg]/8 h), and warm sitz baths. Early complications were recorded at one week revision. Information regarding sex, age, symptoms, bowel habits, examination findings, fissure healing and recurrence was collected at the time of admission and at 2 month, 6 month, one, 2 and 3 year follow-up visits. The follow-up was carried out by other different surgeon attached to the Coloproctology Unit. Healing was defined as complete re-epithelization of the fissure and absence of symptoms. Recurrence of fissure was defined by persistence of fissure in anatomic exploration whether associated with symptoms or not. The Cleveland Clinic Scoring System was used for assessment of incontinence.</p><p class="elsevierStylePara">Generally, there were no significant differences between the 2 groups in the characteristics of patients, symptoms and anal exploration before treatment (table 1).</p><p class="elsevierStylePara"><img src="2v124n15-13074137tab01.gif"></img></p><p class="elsevierStylePara"><span class="elsevierStyleItalic">Statistical analysis</span></p><p class="elsevierStylePara">The data were analyzed by standard statistical methods with the SPSS package version 11.0 for Windows (SPSS Inc., Chicago, IL, USA). The results were expressed as means (standard deviation). Differences between data were compared using Student's t test for paired and unpaired samples, whereas differences between percentages were analyzed using Fisher's exact test. Probability values of less than 0.05 were considered significant. Logistic regression analysis was used to compare variables between the groups. The sample size was estimated before the study, where approximately 40 patients in each arm of the trial were calculated depending on the mean percentage of success obtained in previous studies. An a level of error of 5% and a ß error of 10% were considered appropriate.</p><p class="elsevierStylePara">Results</p><p class="elsevierStylePara">Complications and results of treatment are listed in table 2. We found 2 patients (5%) with an hematoma wound (one in the surgical sphincterotomy group and one in the chemical sphincterotomy group). There were no anal abscesses, hemorrhoid thrombosis, perianal fistulae or urinary retention.</p><p class="elsevierStylePara"><img src="2v124n15-13074137tab02.gif"></img></p><p class="elsevierStylePara">There was persistence or recurrence of the fissure in one patient (7.5%) in the surgical sphincterotomy group and in 6 patients (15%) in the chemical sphincterotomy group (p > 0.05) at the 2 month visit, and one more patient in the surgical sphincterotomy group (overall: 10%) and 6 more patients in the chemical sphincterotomy group (overall: 30%) (p < 0.05) after 6 months. Differences in overall healing were found during the one year review: 36 patients (90%) in the surgical sphincterotomy and 18 patients (45%) in the chemical sphincterotomy group (p < 0.001). There were no new recurrences at 2 and 3 year follow-up.</p><p class="elsevierStylePara">Fissures were significantly less likely to heal in patients in whom the condition had been present for over 12 months and who had a sentinel pile. No relationship was found between the other pre-operative clinical variables analyzed and healing.</p><p class="elsevierStylePara">With regard to incontinence, in the 2 month revision it was present in 2 patients (5%) in the surgical sphincterotomy group (one patient with daily incontinence for fluids and one patient with occasional incontinence for gases) and in 2 patients (5%) in the chemical sphincterotomy group (one patient with occasional incontinence for liquid faeces and one with occasionally incontinent for flatus). At the 6-month revision, all patients of the chemical sphincterotomy group and 2 patient of the surgical sphincterotomy group reported that the incontinence had spontaneously resolved. After one year, only one patient from the surgical sphincterotomy group (2.5%) reported occasional residual incontinence for flatus (< 4, Cleveland score). At the revisions after 2 and 3 years, no changes in incontinence were found. These differences between the 2 groups in the percentages of incontinence with regard to the treatment used were not significant.</p><p class="elsevierStylePara">Out of all the preoperative clinical variables analyzed, only an age above 50 years was associated with incontinence. All the incontinent patients were aged more than 50 years old.</p><p class="elsevierStylePara">Discussion</p><p class="elsevierStylePara">There is still controversy on whether BT is bound to replace surgical sphincterotomy as the treatment of choice for chronic anal fissure. Many studies have been published about treatment with BT<span class="elsevierStyleSup">4-9</span> or surgical sphincterotomy<span class="elsevierStyleSup">1,2</span>, with very different results. No doubt these differences owe to the different methodology used: criteria for inclusion of patients, BT regimen (dose, re-injection, site and number of injections), the amount of sphincter sectioned in surgical sphincterotomy, method for measuring or quantifying healing-recurrence, and follow-up time. In BT treatment, the best results of healing (> 80%) with short follow-up (< 12 months) have been obtained using high doses of BT (25-30 U), directly injected into the internal sphincter, dividing the dose in various injection points. Of note, it is more effective to inject into the anterior than into the posterior face<span class="elsevierStyleSup">5,6,8</span>. However, clinical results from long-term follow-up in patients treated with BT are lacking.</p><p class="elsevierStylePara">There is only one published prospective randomized study comparing BT and surgical sphincterotomy<span class="elsevierStyleSup">7</span> which showed a higher healing degree in the latter group (94%vs75%), although with a short (12 months) clinical follow-up. Our study is, to our knowledge, the first prospective randomized study with a long term (36 months) follow-up.</p><p class="elsevierStylePara">If we analyze the studies with longer follow-up times<span class="elsevierStyleSup">8,9</span>, it is possible to see, as far as BT treatment is concerned, a trend towards progressive recurrence over time with lower healing rates than those initially reported. Mínguez et al<span class="elsevierStyleSup">9</span> reported the longest-term follow-up study (42 months) with a relapse of anal fissure in 41.5% of patients. Our study also shows this trend only in the BT group, since there is a progressive rate of recurrence, which starts at 12% in the early months and reaches 53% at 3 years. In surgical sphincterotomy, the recurrence is lower (< 10%) and not progressive. This is not surprising and could be related to the temporary reversible effect of the toxin, contrary to the surgical sphincterotomy.</p><p class="elsevierStylePara">Some studies have described clinical factors related to recurrence<span class="elsevierStyleSup">9</span>; in our study we could also find some clinical parameters related to a higher rate of recurrence indicating that the fissure had become chronic (duration of disease over 12 months and presence of a sentinel pile). Therefore, reversible sphincterotomy with BT does not appear to be sufficient to achieve definitive healing. We believe that in these patients surgical treatment should be considered as the first therapeutic option in the view of the high probability of recurrence using BT in the long-term follow-up.</p><p class="elsevierStylePara">Furthermore, we found no significant difference between the 2 groups with regard to the immediate complication rates (hemorrhage, hematoma wound, retention of urine) following treatment. The rate of permanent incontinence after 3 years was 2.5% in the surgical sphincterotomy and 0% in the BT group, which is associated with a lower mean resting pressure and mean squeeze pressure than in continent patients. An age higher than 50 years was the only pre-treatment factor associated with an increase in incontinence.</p><p class="elsevierStylePara">Based on these findings, we recommend the use of BT as the first therapeutic approach in patients older than 50 years or with risk factors for incontinence (women who have had multiple vaginal deliveries, prior anal surgery, prior incontinence, inflammatory bowel disease, etc.), despite the higher rate of recurrence associated with this treatment since it avoids the greater risk of incontinence associated with surgery. In patients with long-term recurrence, re-injection with higher doses of BT should be considered. Retreatment with BT has been described as an alternative therapy with very good results in patients with recurrence. Brisinda et al<span class="elsevierStyleSup">6</span> reported a healing rate of 96% employing a reinjection of 50 units of BT in patients with recurrence of fissure. However, it is difficult to ascertain before starting treatment which patients should be administered a higher dose of BT. In fact, higher and thus more effective doses may stimulate the production of antibodies and lead to an increase in the rate of complications and recurrences.</p><p class="elsevierStylePara">Concerning the morbidity of BT<span class="elsevierStyleSup">10</span>, the literature points out its safety on grounds of uncommon associated complications (incontinence, postinjection hemorroidal thrombosis, anal hematoma and epididymitis) and their banal and reversible nature. In our series, only 5% patients reported initial incontinence which was 100% reversible and progressively disappeared as the internal sphincter recovered its functionality.</p>" "pdfFichero" => "2v124n15a13074137pdf001.pdf" "tienePdf" => true "PalabrasClave" => array:2 [ "es" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Palabras clave" "identificador" => "xpalclavsec223599" "palabras" => array:3 [ 0 => "Fisura anal" 1 => "Esfinterotomía" 2 => "Toxina botulínica" ] ] ] "en" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Keywords" "identificador" => "xpalclavsec223600" "palabras" => array:3 [ 0 => "Anal fissure" 1 => "Sphincterotomy" 2 => "Botulinum toxin" ] ] ] ] "tieneResumen" => true "resumen" => array:2 [ "es" => array:1 [ "resumen" => "Fundamento y objetivo: Comparar en un estudio prospectivo y aleatorizado la efectividad y morbilidad del tratamiento con esfinterotomía quirúrgica y toxina botulínica en la fisura anal crónica. Pacientes y método: Se trató a 80 pacientes con fisura anal crónica mediante esfinterotomía lateral interna cerrada (grupo 1) o esfinterotomía química con la inyección en el esfínter interno de 25 U de toxina botulínica (grupo 2). Resultados: La tasa de curación global a los 3 años fue del 90% en la esfinterotomía cerrada y del 45% con la toxina botulínica (p < 0.001). Encontramos un grupo con factores clínicos (duración de la enfermedad mayor de 12 meses y presencia de hemorroide centinela antes del tratamiento) asociados a mayor tasa de recurrencia. La tasa final de incontinencia fue del 5% en la esfinterotomía quirúrgica y del 0% con la toxina botulínica (p > 0.05). Todos los pacientes incontinentes tuvieron una edad superior a 50 años. Conclusiones: Recomendamos la esfinterotomía quirúrgica como la técnica de elección en pacientes con factores de recurrencia. Preferimos la utilización de toxina botulínica en pacientes mayores de 50 años o con factores de riesgo de incontinencia, ya que, a pesar del mayor riesgo de recurrencia, evita el mayor riesgo de incontinencia descrito en la esfinterotomía quirúrgica." ] "en" => array:1 [ "resumen" => "Background and objective: The aim of this prospective randomized trial was to compare the effectiveness and morbidity of surgical vs chemical sphincterotomy in the treatment of chronic anal fissure after a 3-year follow-up period. Patients and method: Eighty patients with chronic anal fissure were treated either with close lateral internal sphincterotomy (group 1) or with chemical sphincterotomy with 25 U botulinum toxin injected into the internal sphincter (group 2). Results: Overall healing was 90% in the close sphincterotomy group and 45% in the toxin botulinum group (p < 0.001). There was a group of patients with clinical factors (duration of disease over 12 months and presence of a sentinel pile before treatment) associated with a higher recurrence of anal fissure. Final percentage of incontinence was 5% in the close sphincterotomy group and 0% in the botulinum toxin group (p > 0.05). All incontinent patients were aged more than 50 years. Conclusions: We recommend surgical sphincterotomy as the first therapeutic approach in patients with clinical factors of recurrence. However, we recommend the use of botulinum toxin in patients older than 50 years or with associated risk factors of incontinence, despite the higher rate of recurrence, since it avoids the greater risk of incontinence seen with surgery." ] ] "multimedia" => array:4 [ 0 => array:6 [ "identificador" => "tbl1" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "copyright" => "Elsevier España" "tabla" => array:1 [ "tablatextoimagen" => array:1 [ 0 => array:1 [ "tablaImagen" => array:1 [ 0 => array:4 [ "imagenFichero" => "2v124n15-13074137tab01.gif" "imagenAlto" => 237 "imagenAncho" => 433 "imagenTamanyo" => 11853 ] ] ] ] ] ] 1 => array:6 [ "identificador" => "tbl2" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "copyright" => "Elsevier España" "tabla" => array:1 [ "tablatextoimagen" => array:1 [ 0 => array:1 [ "tablaImagen" => array:1 [ 0 => array:4 [ "imagenFichero" => "2v124n15-13074137tab02.gif" "imagenAlto" => 225 "imagenAncho" => 428 "imagenTamanyo" => 9695 ] ] ] ] ] ] 2 => array:5 [ "identificador" => "tbl3" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "copyright" => "Elsevier España" ] 3 => array:5 [ "identificador" => "tbl4" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "copyright" => "Elsevier España" ] ] "bibliografia" => array:2 [ "titulo" => "Bibliography" "seccion" => array:1 [ 0 => array:1 [ "bibliografiaReferencia" => array:10 [ 0 => array:3 [ "identificador" => "bib1" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:3 [ "titulo" => "Anal fissure. 20-year experience." 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Article information
ISSN: 00257753Original language: English
DOI:10.1157/13074137
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