Botulinum toxin injection for chronic anal fissure: a prospective controlled study with long follow-up.

BACKGROUND: Botulinum toxin is an effective therapeutic option for chronic anal fissure. However, there is no evidence about treatment standardization and long-term follow-up. We aimed to evaluate the short- and long-term efficacy and safety of botulinum toxin compared to close lateral internal sphincterotomy, with a 5-year follow-up. METHODS: This was a prospective, controlled, single-center study conducted at University Hospital of Ferrara, Ferrara, Italy. The primary outcome was fissure healing at 1 month. Secondary outcomes were Quality-of-Life (QoL) at 1 month and after 5 years, and fissure recurrence at 6 months and 5 years. RESULTS: A total of 59 patients received botulinum toxin injection (Botox), and 32 underwent lateral internal sphincterotomy. At 1 month after treatments, postoperative pain decreased faster and significantly more in the Botox group (30 vs. 60 mm; P<0.001); fissure re-epithelization was observed in 59.4% of the surgical group compared to 25.4% of Botox (P=0.0001). Anal sphincter pressures decreased more in surgical group (P=0.044), although severe anal incontinence was present only in this subset (6.2%; P=0.041). Compared to surgery, patients who received Botox had higher satisfaction rates (P<0.001). Fissure recurrence at 6 months was more common in Botox than surgical group (16.9% vs. 3.2%, respectively; P=0.053). The overall healing rate improved in all patients and persisted at 12 months and 5 years in both groups with overall high patient satisfaction despite mild anal incontinence in 21.8% in the surgery group (P<0.05). CONCLUSIONS: Botox, rather than surgery, should be considered the first-line treatment for chronic anal fissure.

The Italian Unitary Society of Colon-proctology (SIUCP: Società Italiana Unitaria di Colonproctologia) guidelines for the management of anal fissure.

INTRODUCTION: The aim of these evidence-based guidelines is to present a consensus position from members of the Italian Unitary Society of Colon-Proctology (SIUCP: Società Italiana Unitaria di Colon-Proctologia) on the diagnosis and management of anal fissure, with the purpose to guide every physician in the choice of the best treatment option, according with the available literature. METHODS: A panel of experts was designed and charged by the Board of the SIUCP to develop key-questions on the main topics covering the management of anal fissure and to performe an accurate search on each topic in different databanks, in order to provide evidence-based answers to the questions and to summarize them in statements. All the clinical questions were discussed by the expert panel in different rounds through the Delphi approach and, for each statement, a consensus among the experts was reached. The questions were created according to the PICO criteria, and the statements developed adopting the GRADE methodology. CONCLUSIONS: In patients with acute anal fissure the medical therapy with dietary and behavioral norms is indicated. In the chronic phase of disease, the conservative treatment with topical 0.3% nifedipine plus 1.5% lidocaine or nitrates may represent the first-line therapy, eventually associated with ointments with film-forming, anti-inflammatory and healing properties such as Propionibacterium extract gel. In case of first-line treatment failure, the surgical strategy (internal sphincterotomy or fissurectomy with flap), may be guided by the clinical findings, eventually supported by endoanal ultrasound and anal manometry.

Trans-anal irrigation in patients with multiple sclerosis: Efficacy in treating disease-related bowel dysfunctions and impact on the gut microbiota: A monocentric prospective study.

Background: Constipation and faecal incontinence are not so uncommon in patients with multiple sclerosis, impairing quality of life. The gut microbiota is altered in multiple sclerosis patients and likely contributes to disease pathogenesis. Trans-anal irrigation has been proven to allow treatment of neurogenic bowel dysfunction and may affect gut microbiota. Objectives: The primary outcome was trans-anal irrigation effectiveness on constipation and faecal incontinence. The secondary outcome was gut microbiota profiling compared to healthy subjects and during trans-anal irrigation adoption. Methods: We conducted a prospective cohort study on multiple sclerosis patients, screened with Patient Assessment of Constipation Quality of Life questionnaire before undergoing constipation and faecal incontinence scoring, abdomen X-ray for intestinal transit time, compilation of food and evacuation diaries and faecal sample collection for gut microbiota analysis before and after 4 weeks of trans-anal irrigation. Results and Conclusions: Eighty patients were screened of which nearly half had intestinal symptoms. The included population (n = 37) was predominantly composed of women with significantly longer disease duration, higher mean age and disability than the excluded one (p < 0.05). Twelve patients completed the trans-anal irrigation phase, which led to significant improvement of bowel dysfunction symptom-related quality of life, increase in gut microbiota diversity and reduction of the proportions of pro-inflammatory taxa (p < 0.05). Trans-anal irrigation was safe, satisfactory and could help counteract multiple sclerosis-related dysbiosis.

Post-Operative All-Cause Mortality in Elderly Patients Undergoing Abdominal Emergency Surgery: Role of Charlson Comorbidity Index.

(1) Background: The Charlson comorbidity index (CCI) score has been shown to predict 10-year all-cause mortality, but its validity is a matter of debate in surgical patients. We wanted to evaluate CCI on predicting all-cause mortality in elderly patients undergoing emergency abdominal surgery (EAS); (2) Methods: This retrospective single center study included all patients aged 65 years or older consecutively admitted from January 2017 to December 2019, who underwent EAS and were discharged alive. CCI was calculated by using of the International Classification of Diseases, 9th Revision, Clinical Modification codes. Our outcome was all-cause death recorded during the 20.8 ± 8.8 month follow-up; (3) Results: We evaluated 197 patients aged 78.4 ± 7.2 years of whom 47 (23.8%) died. Mortality was higher in patients who underwent open abdominal surgery than in those treated with laparoscopic procedure (74% vs. 26%, p < 0.001), and in those who needed colon, small bowel, and gastric surgery. Mean CCI was 4.98 ± 2.2, and in subjects with CCI ≥ 4 survival was lower. Cox regression analysis showed that CCI (HR 1.132, 95% CI 1.009-1.270, p = 0.035), and open surgery (HR 10.298, 95%CI 1.409-75.285, p = 0.022) were associated with all-cause death independently from age and sex; (4) Conclusions: Calculation of CCI, could help surgeons in the preoperative stratification of risk of death after discharge in subjects aged ≥65 years who need EAS. CCI ≥ 4, increases the risk of all-causes mortality independently from age.

Efficacy and Safety of Treatment of Complex Idiopathic Fistula-in-Ano Using Autologous Centrifuged Adipose Tissue Containing Progenitor Cells: A Randomized Controlled Trial.

BACKGROUND: Mesenchymal stem cells derived from adipose tissue have been successfully used to promote sphincter-saving anal fistula healing. OBJECTIVE: The aim of this study was to evaluate the efficacy and safety of the use of autologous centrifuged adipose tissue in the healing process of cryptoglandular complex anal fistulas. DESIGN: This is a randomized controlled trial. SETTINGS: This study was conducted at a single center. PATIENTS: Patients with complex perianal fistulas not associated with Crohn's disease were included. Rectovaginal fistulas were not included. INTERVENTIONS: Patients were randomly allocated to receive treatment with centrifuged adipose tissue injection (experimental group) and without injection (control group) in combination with fistula surgery. MAIN OUTCOME MEASURES: The primary outcome was defined as the proportion of patients with complete fistula closure at 4 weeks (short-term outcome) and 6 months after surgery (long-term outcome). Healing was defined as when the external opening was closed with no perianal discharge on clinical assessment. The secondary outcome was safety that was evaluated by the analysis of adverse events up to 3 months after surgery. Pelvic MRI was performed at 3 months to assure safety and the accuracy of the clinical determination of healing. Postoperative pain, return to work/daily activities, persistent closure at 6 months, fecal incontinence, and patient satisfaction were evaluated. RESULTS: Fifty-eight patients who received centrifuged adipose tissue injection and 58 patients who did not receive centrifuged adipose tissue injection were included in the safety and efficacy analysis. After 4 weeks, the healing rate was 63.8% in the experimental group compared with 15.5% in the control group (p < 0.001). No major adverse events were recorded. Postoperative anal pain was significantly lower in the injection group. Time taken to return to work/daily activities was significantly shorter in the experimental group (3 days) than in the control group (17 days). At 6 months, persistent closure was similar in the 2 groups (86.2% vs 81%). Fecal Incontinence Score at 6 months after surgery was identical to the preoperative score. Patient satisfaction was high in both groups. LIMITATIONS: The absence of blinding, the lack of correlation between stem cell content, and the clinical outcome were limitations of the study. CONCLUSIONS: Autologous centrifuged adipose tissue injection may represent a safe, efficacious, and inexpensive option for the treatment of complex fistula-in-ano. See Video Abstract at http://links.lww.com/DCR/B607. CLINICAL TRIALS REGISTRATION: URL: https://www.clinicaltrials.gov. Identifier: NCT04326907. EFICACIA Y SEGURIDAD DEL TRATAMIENTO DE LA FSTULA ANAL COMPLEJA IDIOPTICA UTILIZANDO TEJIDO ADIPOSO CENTRIFUGADO AUTLOGO QUE CONTIENE CLULAS PROGENITORAS UN ENSAYO CONTROLADO ALEATORIO: ANTECEDENTES:Las células madre mesenquimales derivadas del tejido adiposo se han utilizado con éxito para promover la curación de la fístula anal con preservación de esfínter.OBJETIVO:El objetivo de este estudio fue evaluar la eficacia y seguridad del uso de tejido adiposo autólogo centrifugado en el proceso de cicatrización de fístulas anales complejas de origen criptoglandular.DISEÑO:Ensayo controlado aleatorio.ENTORNO CLÍNICO:Estudio unicéntrico.PACIENTES:Se incluyeron pacientes con fístulas perianales complejas no asociadas a Enfermedad de Crohn. No se incluyeron las fístulas rectovaginales.INTERVENCIONES:Los pacientes fueron asignados aleatoriamente para recibir tratamiento con inyección de tejido adiposo centrifugado (grupo experimental) y sin inyección (grupo de control) en combinación con cirugía de fístula.PRINCIPALES MEDIDAS DE VALORACIÓN:El resultado primario se definió como la proporción de pacientes con cierre completo de la fístula a las 4 semanas (resultado a corto plazo) y 6 meses después de la cirugía (resultado a largo plazo). La curación se definió cuando orificio externo se cerró sin secreción perianal en la valoración clínica. El resultado secundario fue la seguridad que se evaluó mediante el análisis de los eventos adversos (EA) hasta 3 meses después de la cirugía. La resonancia magnética pélvica se realizó a los 3 meses para garantizar la seguridad y la precisión clínica de la curación. Se evaluó el dolor postoperatorio, el regreso al trabajo / actividades diarias, el cierre persistente a los 6 meses, la incontinencia fecal y la satisfacción del paciente.RESULTADOS:Cincuenta y ocho pacientes que recibieron inyección de tejido adiposo centrifugado y 58 pacientes que no recibieron inyección de tejido adiposo centrifugado se incluyeron en el análisis de seguridad y eficacia. Después de 4 semanas, la tasa de curación fue del 63,8% en el grupo experimental en comparación con el 15,5% en el grupo de control (p <0,001). No se registraron eventos adversos importantes. El dolor anal posoperatorio fue significativamente menor en el grupo de inyección. El tiempo necesario para volver al trabajo / actividades diarias fue significativamente menor en el grupo experimental (3 días) con respecto al grupo de control (17 días). A los 6 meses, el cierre persistente fue similar en los dos grupos (86,2% vs 81%). La puntuación de incontinencia fecal a los 6 meses después de la cirugía fue idéntica a la puntuación preoperatoria. La satisfacción del paciente fue muy alta en ambos grupos.LIMITACIONES:Ausencia de cegamiento, falta de correlación entre el contenido de células madre y el resultado clínico.CONCLUSIONES:La inyección de tejido adiposo centrifugado autólogo puede representar una opción segura, eficaz y económica para el tratamiento de la fístula anal compleja.Registro de ensayos clínicos: www.clinicaltrials.gov, identificador NCT04326907; No patrocinado.Consulte Video Resumen en http://links.lww.com/DCR/B607.

Impact of Ambulatory Surgery for Hemorrhoidal Disease on Clinical Outcomes and Institutional Costs / Impacto da cirurgia ambulatória para patologia hemorroidária nos resultados clínicos e custos

Abstract Objective Transanal hemorrhoidal artery ligation with mucopexy (ligation anopexy [LA]) and open hemorrhoidectomy (OH) can both be performed under local anesthesia. The aim of the present study was to analyze the impact and the cost-effectiveness of performing these techniques in an ambulatory setting of an Italian academic center on the postoperative outcome. Methods A series of 122 consecutive patients with grades II and III hemorrhoidal disease undergoing ambulatory surgical treatment of hemorrhoids in 2015 to 2018 (group A) was comparedwith 122 patients operated at the same institution in the same period (group H) in a hospital setting. The primary outcome was the number of days required to return to work/daily activities. Secondary outcomes included postoperative pain and complications, costeffectiveness, patient satisfaction, and recurrence at 12 months. In group A, all the procedures were performed under local anesthesia with early discharge. In group H, the procedureswere performed under general or loco-regional anesthesia with hospital admission. Results The mean number of days required to return to work/daily activities was 8.4 ± 4.8 days in group A, compared with 12.5 ± 3 days in group H (p<0.001). The visual analog scale (VAS) pain score at 1 week, 2 and 3 weeks, and 1 month after surgery was lower for patients undergoing LA in the ambulatory setting (p<0.01). We observedmore postoperative complications in hospitalized (12.5%) than in ambulatory patients (7.5%) (p<0.001). The total mean direct costs per patient were significantly lower in the ambulatory setting versus the hospital stay group (351.3 versus 1,746 euros). Conclusion Implementing ambulatory surgery for hemorrhoids is feasible, safe, and cost-effective.

Resumo Objetivo A ligação transanal da artéria hemorroidária com mucopexia e a hemorroidectomia aberta (HA) podem ser realizadas em anestesia local. O objetivo do presente estudo foi analisar o impacto no resultado pós-operatório e a relação custo-eficácia da realização destas técnicas em ambiente ambulatorial de um centro acadêmico italiano no desfecho pós-operatório. Métodos Uma série de 122 pacientes consecutivos com patologia hemorroidária de graus II e III submetidos a cirurgia de hemorroidas em regime ambulatório de 2015 a 2018 (grupo A) foi comparada com 122 pacientes operados na mesma instituição no mesmo período (grupo H) por hospitalização. O desfecho primário foi o número de dias necessários para regressar ao trabalho/atividades diárias. Os desfechos secundários incluíram dor e complicações pós-operatórias, custo-eficácia, satisfação do paciente, e recidiva aos 12 meses. No grupo A, todos os procedimentos foram realizados em anestesia local. No grupo H, os procedimentos foram realizados em anestesia geral ou loco-regional. Resultados A espera média para o regresso ao trabalho foi de 8,4 ± 4,8 dias no grupo A em comparação com 12,5 ± 3 dias no grupo H (p<0,001). A pontuação na escala visual analógica (EVA) da dor 1 semana, 2 e 3 semanas, e 1 mês após a cirurgia foi mais baixa para os pacientes submetidos a cirurgia de ligadura com anopexia em ambiente ambulatorial (p<0,01). Observamosmais complicações pós-operatórias empacientes hospitalizados (12,5%) do que em pacientes ambulatórios (7,5%) (p<0,001). Os custos diretosmédios totais por paciente foram mais baixos em ambiente ambulatório do que no grupo de hospitalização (351,3 contra 1.746 euros). Conclusão A implementação da cirurgia ambulatória para hemorroidas é possível, segura e rentável.

Enhanced Recovery Program in Laparoscopic Colorectal Surgery: An Observational Controlled Trial.

Background: Most of the evidence for enhanced recovery programs (ERPs) in colorectal surgery relies on nonrandomized studies with control groups either historical or operated on at different facilities. The aim of this study was to investigate ERP in coeval groups admitted in different wards at the same hospital. Materials and Methods: A prospective cohort of consecutive patients (n = 100) undergoing elective laparoscopic colorectal resection completing a standardized ERP (ERP group) was compared with patients (n = 100) operated with traditional perioperative care in the same period at the same institution (non-ERP group). The two groups were located in separate wards and shared the same anesthesiologists. The exclusion criteria were: >80 years old, American Society of Anesthesia (ASA) IV, metastatic disease, and inflammatory bowel disease. The primary outcome was hospital length of stay (LoS), used as a proxy of functional recovery. Secondary outcomes included: postoperative complications, readmission rate, mortality, and protocol adherence. Results: The ERP group protocol adherence was 81%. The LoS was significantly reduced in the ERP group (4 versus 7 days). The number of 30-day postoperative complications was lower in the ERP group (P < .001). No increase was found in 30-day readmission or mortality. Conventional perioperative protocol was the only predictor of any postoperative complication and, together with male sex and age 65-74 years old, was the only factor associated with prolonged LoS. Conclusion: Implementing a colorectal ERP is feasible, safe, and efficient for functional recovery, but high protocol adherence is needed. Following traditional perioperative care is associated with more postoperative complications and prolonged LoS.

Classification and guidelines of hemorrhoidal disease: Present and future.

Classification and guidelines of hemorrhoidal disease are based on the subdivision in Grades of prolapse followed by any aspect related to both the treatment and its technique. When taking the proposals for classification and guidelines issued by prolific scientific societies into consideration, it is evident that strong contradictions and interpretative limits emerge in finding the best treatment to be adopted. After a critical examination of these limitations, a methodological proposal is shared to achieve a new classification, which plays a part in forming a new guideline for hemorrhoidal disease, identifying its evolution, dynamism of the prolapse, symptomatology, enteropathogenesis and gender characteristics.

Impact of a colorectal enhanced recovery program implementation on clinical outcomes and institutional costs: A prospective cohort study with retrospective control.

BACKGROUND: The enhanced recovery program for perioperative care of the surgical patient reduces postoperative metabolic response and organ dysfunction, accelerating functional recovery. The aim of this study was to determine the impact on postoperative recovery and cost-effectiveness of implementing a colorectal enhanced recovery program in an Italian academic centre. MATERIALS AND METHODS: A prospective series of consecutive patients (N = 100) undergoing elective colorectal resection completing a standardized enhanced recovery program in 2013-2015 (ERP group) was compared to patients (N = 100) operated at the same institution in 2010-2011 (Pre-ERP group) before introducing the program. The exclusion criteria were: >80 years old, ASA score of IV, a stage IV TNM, and diagnosis of inflammatory bowel disease. The primary outcome was hospital length of stay which was used as a proxy of functional recovery. Secondary outcomes included: postoperative complications, 30-day readmission and mortality, protocol adherence, nursing workload, cost-effectiveness, and factors predicting prolonged hospital stay. The ERP group patient satisfaction was also evaluated. RESULTS: Hospital stay was significantly reduced in the ERP versus the Pre-ERP group (4 versus 8 days) as well as nursing workload, with no increase in postoperative complications, 30-day readmission or mortality. ERP group protocol adherence (81%) and patient satisfaction were high. Conventional perioperative protocol was the only independent predictor of prolonged hospital stay. Total mean direct costs per patient were significantly higher in the Pre-ERP versus the ERP group (6796.76 versus 5339.05 euros). CONCLUSIONS: Implementing a colorectal enhanced recovery program is feasible, efficient for functional recovery and hospital stay reduction, safe, and cost-effective. High patient satisfaction and nursing workload reduction may also be expected, but high protocol adherence is necessary.

[Long stapled haemorrhoidectomy versus Milligan-Morgan procedure: short- and long-term results of a randomised, controlled, prospective trial]. / Emorroidectomia secondo Longo vs Milligan-Morgan: risultati a breve e lungo termine di uno studio prospettico, randomizzato, controllato. Analisi costo-beneficio.

The aim of this study was to assess the short- and long-term results of treatment for haemorrhoids by prospectively comparing two techniques, namely, stapled rectal prolapse mucosectomy according to Longo and open hemorrhoidectomy. One hundred consecutive patients were randomised to stapled (50 patients) or manual hemorrhoidectomy (50 patients). We analysed postoperative pain, preoperative and postoperative anorectal function, intraoperative and postoperative complications, time needed to return to work and to normal social activities, and costs. Long-term follow data were obtained by means of an outpatient visit. The operative time of the stapled technique was less than that of open haemorrhoidectomy (22 vs 35 minutes). Two cases of early postoperative bleeding occurred after the stapled technique. The mean pain score on a visual scale was significantly less in patients undergoing the stapled technique. In addition, the time needed to return to work and to normal social activities was significantly less after the stapled technique, which, however, proved to be a more expensive procedure. Stapled mucosectomy of the prolapsed rectal mucosa is a safe, rapid, and relatively painless technique, which has a low incidence of complications. It can be performed in a day surgery unit. Patient satisfaction, early return to normal activities and good long-term results counterbalance the high cost of the procedure.

Early and late outcome after surgery for colorectal cancer: elective versus emergency surgery.

AIMS AND BACKGROUND: Emergency surgery for colorectal cancer is associated with a higher postoperative morbidity and mortality rate and a poor long-term outcome compared with elective surgery. The aim of the present study was to compare early and late outcome after elective and emergency surgery for malignant colorectal cancer, looking for the principal determinants of a worse outcome after emergency colorectal surgery. METHODS: A retrospective study of 236 patients presenting with colorectal cancer over an 8-year period was undertaken. Of these, 118 presented as emergencies, whereas 118 patients, well matched for age, sex, site of tumor and TNM admitted as elective, were included in the study. Data reviewed included postoperative mortality and morbidity and long-term outcome. RESULTS: The 30-day operative mortality rate was significantly higher in the emergency group than in the electively treated group (11.9% versus 3.4%, P < 0.01). The higher mortality rate was observed in the perforation group. The 30-day operative morbidity was higher in the emergency group (27.1% versus 12.7%, P < 0.05). Anastomotic failure was a serious complication: following primary resection, we observed 4 non-fatal (5.4%) and two fatal (2.7%) anastomotic leaks after 74 primary anastomoses. Among emergency-treated patients, the procedures characterized by the highest percentage of postoperative complications were three-stage resections (63.6%). The 5-year survival rate was greater after elective surgery (59% versus 39%). CONCLUSIONS: The early and long-term outcome following emergency colorectal surgery was significantly lower than that after elective surgery. Although medical complications in patients with end-stage cancer played an important role, surgical failures still had an important impact on outcome.

Primary rectal lymphoma as a cause of bowel obstruction. Report of a case.

BACKGROUND: Malignant lymphoma involving the rectum either as a localized process or as a manifestation of disseminated disease is rare. Several treatments have been proposed and reported, including surgical resection alone or associated with adjuvant chemoradiation, chemotherapy alone, and radiotherapy alone. METHODS: A case of bowel obstruction caused by a primary rectal MALT lymphoma is reported. Following emergency loop sigmoid colostomy the patient was started on multiple specific cycles of chemotherapy according to the MACOP-B protocol. RESULTS: At the end of chemotherapy a remarkable reduction in the size of the tumor was noted. Subsequently the patient underwent an ultralow anterior resection followed by a straight coloanal anastomosis. At 36 months of follow-up the patient is alive with no tumor recurrence. CONCLUSIONS: The present report describes the unique case of a patient with primary obstructing rectal lymphoma treated with neoadjuvant chemotherapy and sphincter-saving curative surgery.

[Impact of the sentinel lymph node in the staging of colorectal carcinoma]. / Impatto del linfonodo sentinella nella stadiazione del carcinoma colorettale.

In view of the very good results obtained by lymphatic mapping and sentinel node biopsy in the staging of patients with melanoma or breast cancer, we investigated the feasibility of intraoperative regional lymphatic mapping in patients with primary colorectal carcinoma. The aim of this study was to determine whether lymphatic mapping and sentinel node assessment can identify aberrant drainage patterns or make for better staging of the neoplasm in those cases with no or only minimal lymphatic neoplastic involvement. Sixteen consecutive patients with primary colorectal cancer (stage T2-T3) but without macroscopic involvement of the lymphatic system underwent intraoperative lymphatic mapping by injecting 1-1.5 ml of isosulfan blue dye. The identified and resected sentinel nodes were examined using conventional haematoxylin-eosin staining and cytokeratin immunohistochemistry. Sentinel node identification was successful in 15 out of 16 cases (93.8%). In 11 cases (73.3%) sentinel node status correctly predicted the final staging. The false-negative rate was 26.7%. Immunohistochemical analysis revealed the presence of micrometastasis in one case (6.7%), which was consequently upstaged. In cases of colorectal cancer lymphatic mapping is an easy, perfectly feasible technique. However, in our experience, it would not appear to significantly improve the accuracy of the histopathological staging of colorectal carcinoma.