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American Family Physician Jan 2020Common anorectal conditions include hemorrhoids, perianal pruritus, anal fissures, functional rectal pain, perianal abscess, condyloma, rectal prolapse, and fecal... (Review)
Review
Common anorectal conditions include hemorrhoids, perianal pruritus, anal fissures, functional rectal pain, perianal abscess, condyloma, rectal prolapse, and fecal incontinence. Although these are benign conditions, symptoms can be similar to those of cancer, so malignancy should be considered in the differential diagnosis. History and examination, including anoscopy, are usually sufficient for diagnosing these conditions, although additional testing is needed in some situations. The primary treatment for hemorrhoids is fiber supplementation. Patients who do not improve and those with large high-grade hemorrhoids should be referred for surgery. Acutely thrombosed external hemorrhoids should be excised. Perianal pruritus should be treated with hygienic measures, barrier emollients, and low-dose topical corticosteroids. Capsaicin cream and tacrolimus ointment are effective for recalcitrant cases. Treatment of acute anal fissures with pain and bleeding involves adequate fluid and fiber intake. Chronic anal fissures should be treated with topical nitrates or calcium channel blockers, with surgery for patients who do not respond to medical management. Patients with functional rectal pain should be treated with warm baths, fiber supplementation, and biofeedback. Patients with superficial perianal abscesses not involving the sphincter should undergo office-based drainage; patients with more extensive abscesses or possible fistulas should be referred for surgery. Condylomata can be managed with topical medicines, excision, or destruction. Patients with rectal prolapse should be referred for surgical evaluation. Biofeedback is a first-line treatment for fecal incontinence, but antidiarrheal agents are useful if diarrhea is involved, and fiber and laxatives may be used if impaction is present. Colostomy can help improve quality of life for patients with severe fecal incontinence.
Topics: Anus Diseases; Diagnosis, Differential; Evidence-Based Medicine; Female; Humans; Male; Practice Guidelines as Topic
PubMed: 31894930
DOI: No ID Found -
Gastroenterology Jun 2021The incidence and prevalence of Crohn's disease (CD) is rising globally. Patients with moderate to severe CD are at high risk for needing surgery and hospitalization and... (Review)
Review
The incidence and prevalence of Crohn's disease (CD) is rising globally. Patients with moderate to severe CD are at high risk for needing surgery and hospitalization and for developing disease-related complications, corticosteroid dependence, and serious infections. Optimal management of outpatients with moderate to severe luminal and/or fistulizing (including perianal) CD often requires the use of immunomodulator (thiopurines, methotrexate) and/or biologic therapies, including tumor necrosis factor-α antagonists, vedolizumab, or ustekinumab, either as monotherapy or in combination (with immunomodulators) to mitigate these risks. Decisions about optimal drug therapy in moderate to severe CD are complex, with limited guidance on comparative efficacy and safety of different treatments, leading to considerable practice variability. Since the last iteration of these guidelines published in 2013, significant advances have been made in the field, including the regulatory approval of 2 new biologic agents, vedolizumab and ustekinumab. Therefore, the American Gastroenterological Association prioritized updating clinical guidelines on this topic. To inform the clinical guidelines, this technical review was completed in accordance with the GRADE (Grading of Recommendations Assessment, Development and Evaluation) framework. The review addressed the following focused questions (in adult outpatients with moderate to severe luminal CD): overall and comparative efficacy of different medications for induction and maintenance of remission in patients with or without prior exposure to tumor necrosis factor-α antagonists, comparative efficacy and safety of biologic monotherapy vs combination therapy with immunomodulators, comparative efficacy of a top-down (upfront use of biologics and/or immunomodulator therapy) vs step-up treatment strategy (acceleration to biologic and/or immunomodulator therapy only after failure of mesalamine), and the role of corticosteroids and mesalamine for induction and/or maintenance of remission. Finally, in adult outpatients with moderate to severe fistulizing CD, this review addressed the efficacy of pharmacologic interventions for achieving fistula and the role of adjunctive antibiotics without clear evidence of active infection.
Topics: Adult; Crohn Disease; Decision Support Systems, Clinical; Disease Management; Female; Gastroenterology; Humans; Male; Practice Guidelines as Topic; Rectal Fistula; Severity of Illness Index; Societies, Medical
PubMed: 34051985
DOI: 10.1053/j.gastro.2021.04.023 -
Stem Cell Research & Therapy Apr 2023Perianal fistulas, characterised as granulomatous inflammation of fistulas around the anal canal, are associated with significant morbidity resulting in a negative... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Perianal fistulas, characterised as granulomatous inflammation of fistulas around the anal canal, are associated with significant morbidity resulting in a negative impact on quality of life and a tremendous burden to the healthcare system. Treatment of anal fistulas usually consists of anal surgery; however, results of closure rates are not satisfactory especially with complex perianal fistulas, after which many patients may suffer from anal incontinence. Recently, the administration of mesenchymal stem cells (MSCs) has shown promising efficacy. Herein, we aim to explore whether MSCs are effective for complex perianal fistulas and if they have either short-term, medium-term, long-term or over-long-term efficacy. Additionally, we want to elucidate whether factors such as drug dosage, MSC source, cell type, and disease aetiology influence treatment efficacy. We searched four online databases and analysed data based on information within the clinical trials registry. The outcomes of eligible trials were analysed with Review Manager 5.4.1. Relative risk and related 95% confidence interval were calculated to compare the effect between the MSCs and control groups. In addition, the Cochrane risk of bias tool was applied to evaluate the bias risk of eligible studies. Meta-analyses showed that therapy with MSCs was superior to conventional treatment for complex perianal fistulas in short-, long- and over-long-term follow-up phases. However, there was no statistical difference in treatment efficacy in the medium term between the two methods. Subgroup meta-analyses showed factors including cell type, cell source and cell dosage were superior compared to the control, but there was no significant difference between different experimental groups of those factors. Besides, local MSCs therapy has shown more promising results for fistulas as a result of Crohn's Disease (CD). Although we tend to maintain that MSCs therapy is effective for cryptoglandular fistulas equally, more studies are needed to confirm this conclusion in the future.
SHORT CONCLUSION
MSCs Transplantation could be a new therapeutic method for complex perianal fistulas of both cryptoglandular and CD origin showing high efficacy in the short-term to over-long-term phases, as well as high efficacy in sustained healing. The difference in cell types, cell sources and cell dosages did not influence MSCs' efficacy.
Topics: Humans; Quality of Life; Mesenchymal Stem Cell Transplantation; Treatment Outcome; Mesenchymal Stem Cells; Rectal Fistula; Crohn Disease
PubMed: 37101285
DOI: 10.1186/s13287-023-03331-6 -
Diseases of the Colon and Rectum May 2022Darvadstrocel is an expanded allogeneic adipose-derived mesenchymal stem cell therapy for the treatment of complex perianal fistulas in patients with Crohn's disease.... (Randomized Controlled Trial)
Randomized Controlled Trial
Follow-up Study to Evaluate the Long-term Safety and Efficacy of Darvadstrocel (Mesenchymal Stem Cell Treatment) in Patients With Perianal Fistulizing Crohn's Disease: ADMIRE-CD Phase 3 Randomized Controlled Trial.
BACKGROUND
Darvadstrocel is an expanded allogeneic adipose-derived mesenchymal stem cell therapy for the treatment of complex perianal fistulas in patients with Crohn's disease. Safety and efficacy outcomes from the clinical trial known as "Adipose derived mesenchymal stem cells for induction of remission in perianal fistulizing Crohn's disease," or ADMIRE-CD (NCT01541579), from up to 52 weeks posttreatment were previously reported. Here, the outcomes from an extended 104-week follow-up are reported.
OBJECTIVE
The goal of this study was to assess the long-term safety and efficacy of darvadstrocel at 2 years post-treatment in patients with Crohn's disease and complex perianal fistulas.
DESIGN
This was a phase 3 double-blind randomized controlled study (ADMIRE-CD) in patients with perianal fistulizing Crohn's disease.
SETTINGS
This study extension was conducted in multiple hospitals across 7 European countries and Israel.
PATIENTS
Forty patients entered the extended follow-up period: 25 patients in the darvadstrocel treatment group and 15 in the control group.
INTERVENTIONS
Darvadstrocel or saline solution (control group) was administered once, locally, after fistula tract curettage and internal opening closure (with previous seton placement). All patients were permitted to continue ongoing medical treatments for fistulas.
MAIN OUTCOME MEASURES
Treatment-emergent serious adverse events were recorded through week 104. Clinical remission, defined as closure of all treated external openings that were draining at baseline despite gentle finger compression, was assessed at week 104.
RESULTS
Of 40 patients, 37 completed the extended follow-up. Through week 104, 7 treatment-emergent serious adverse events were reported, of which 4 occurred between weeks 52 and 104. At week 104, clinical remission was reported in 14/25 (56%) patients in the darvadstrocel group and 6/15 (40%) patients in the control group.
LIMITATIONS
Limitations include the small number of patients who entered the extended follow-up period, and no imaging examinations were performed at the 104-week time point.
CONCLUSIONS
Darvadstrocel was well tolerated and clinical remission after treatment with darvadstrocel may be sustained for up to 104 weeks in patients with perianal fistulizing Crohn's disease. See Video Abstract at http://links.lww.com/DCR/B812.ClinicalTrials.gov No: NCT01541579.
ESTUDIO DE SEGUIMIENTO PARA EVALUAR LA SEGURIDAD Y EFICACIA A LARGO PLAZO DE DARVADSTROCEL TRATAMIENTO CON CLULAS MADRE MESENQUIMALES EN PACIENTES CON ENFERMEDAD DE CROHN PERIANAL FISTULIZANTE ENSAYO CONTROLADO ALEATORIZADO DE FASE ADMIRECD
ANTECEDENTES:Darvadstrocel es una terapia con células madre mesenquimales alogénicas expandidas derivadas de tejido adiposo para el tratamiento de fístulas perianales complejas en pacientes con enfermedad de Crohn. Los resultados del ensayo clínico conocido como "Células madre mesenquimales derivadas de tejido adiposo para la inducción de la remisión en la enfermedad de Crohn fistulizante perianal" o ADMIRE-CD (NCT01541579), en cuanto a la seguridad y eficacia hasta 52 semanas después del tratamiento, fueron previamente informados. Seguidamente, se presentan los resultados de un seguimiento extendido de 104 semanas.OBJETIVO:Evaluar la seguridad y eficacia a largo plazo de darvadstrocel a dos años del tratamiento en pacientes con enfermedad de Crohn y fístulas perianales complejas.DISEÑO:Este fue un estudio de fase 3, aleatorizado, a doble ciego, controlado (ADMIRE-CD) en pacientes con enfermedad de Crohn perianal fistulizante.DESARROLLO:Esta extensión del estudio se realizó en varios hospitales de siete países europeos e Israel.PACIENTES:Cuarenta pacientes participaron en la extensión de seguimiento: tratamiento con darvadstrocel (n = 25); grupo control (n = 15).INTERVENCIONES:Se administró Darvadstrocel o solución salina (grupo control) una vez, localmente, tras el legrado del trayecto fístuloso y cierre del orificio interno (con la colocación previa de setón). A todos los pacientes se les permitió continuar con los tratamientos médicos en curso para las fístulas.PRINCIPALES MEDIDAS DE RESULTADO:Los eventos de efectos adversos graves derivados del tratamiento se registraron hasta la semana 104. La remisión clínica, definida como el cierre de todas las aberturas externas tratadas que drenaban al inicio espontáneamente o por compresión suave de los dedos, fue evaluado en la semana 104.RESULTADOS:Del total de 40 pacientes, 37 completaron la extensión de seguimiento. Hasta la semana 104, se reportaron 7 eventos de efectos adversos graves resultantes del tratamiento, de los cuales 4 ocurrieron entre las semanas 52 y 104. En la semana 104, se reportó remisión clínica en 14/25 (56%) pacientes en el grupo de darvadstrocel y 6/15 (40%) pacientes en el grupo de control.LIMITACIONES:Solo una pequeña cantidad de pacientes participaron en el período de seguimiento extendido y no se realizaron exámenes por técnicas de imagen en la visita a 104 semanas.CONCLUSIONES:Darvadstrocel fue bien tolerado y la remisión clínica después del tratamiento con darvadstrocel puede mantenerse hasta 104 semanas en pacientes con enfermedad de Crohn perianal fistulizante. Consulte Video Resumen en http://links.lww.com/DCR/B812. (Traducción-Dr Osvaldo Gauto and Dr Julian Panés.)ClinicalTrials.gov No. NCT01541579.
Topics: Crohn Disease; Europe; Follow-Up Studies; Humans; Mesenchymal Stem Cells; Retrospective Studies; Stem Cell Transplantation
PubMed: 34890373
DOI: 10.1097/DCR.0000000000002325 -
Clinics in Colon and Rectal Surgery Sep 2019This article provides an overview of the principles in the evaluation and management of perianal Crohn's disease (CD). Manifestation-specific treatment is addressed... (Review)
Review
This article provides an overview of the principles in the evaluation and management of perianal Crohn's disease (CD). Manifestation-specific treatment is addressed including abscess, fistula, skin tags, hemorrhoids, fissure, ulcers, strictures, ano-, and rectovaginal fistulas as well CD-associated hidradenitis suppurativa.
PubMed: 31507348
DOI: 10.1055/s-0039-1687834 -
The British Journal of Surgery Sep 2022Perianal abscess is common. Traditionally, postoperative perianal abscess cavities are managed with internal wound packing, a practice not supported by evidence. The aim... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Perianal abscess is common. Traditionally, postoperative perianal abscess cavities are managed with internal wound packing, a practice not supported by evidence. The aim of this randomized clinical trial (RCT) was to assess if non-packing is less painful and if it is associated with adverse outcomes.
METHODS
The Postoperative Packing of Perianal Abscess Cavities (PPAC2) trial was a multicentre, RCT (two-group parallel design) of adult participants admitted to an NHS hospital for incision and drainage of a primary perianal abscess. Participants were randomized 1:1 (via an online system) to receive continued postoperative wound packing or non-packing. Blinded data were collected via symptom diaries, telephone, and clinics over 6 months. The objective was to determine whether non-packing of perianal abscess cavities is less painful than packing, without an increase in perianal fistula or abscess recurrence. The primary outcome was pain (mean maximum pain score on a 100-point visual analogue scale).
RESULTS
Between February 2018 and March 2020, 433 participants (mean age 42 years) were randomized across 50 sites. Two hundred and thirteen participants allocated to packing reported higher pain scores than 220 allocated to non-packing (38.2 versus 28.2, mean difference 9.9; P < 0.0001). The occurrence of fistula-in-ano was low in both groups: 32/213 (15 per cent) in the packing group and 24/220 (11 per cent) in the non-packing group (OR 0.69, 95 per cent c.i. 0.39 to 1.22; P = 0.20). The proportion of patients with abscess recurrence was also low: 13/223 (6 per cent) in the non-packing group and 7/213 (3 per cent) in the packing group (OR 1.85, 95 per cent c.i. 0.72 to 4.73; P = 0.20).
CONCLUSION
Avoiding abscess cavity packing is less painful without a negative morbidity risk.
REGISTRATION NUMBER
ISRCTN93273484 (https://www.isrctn.com/ISRCTN93273484).
REGISTRATION NUMBER
NCT03315169 (http://clinicaltrials.gov).
Topics: Abscess; Adult; Anus Diseases; Bandages; Drainage; Humans; Pain; Rectal Fistula; Treatment Outcome
PubMed: 35929816
DOI: 10.1093/bjs/znac225 -
Clinics in Colon and Rectal Surgery Sep 2019Anal cancer is a heterogeneous and rare disease process that accounts for ∼1.5% of all gastrointestinal tract malignancies. The perianal skin plays host to a variety... (Review)
Review
Anal cancer is a heterogeneous and rare disease process that accounts for ∼1.5% of all gastrointestinal tract malignancies. The perianal skin plays host to a variety of different premalignant and malignant lesions, all with variable histology, treatment options, and prognosis. Anal cancers in general are notorious for having a delayed or missed diagnosis leading to treatment delays and may have an impact on survival. This delay is in part due to the nonspecific symptomatology and also improper physical examination of the sensitive and anatomically complex perianal region and anal canal. This article examines the various types of perianal cancers and their precursor lesions and will explore treatment options as well as outcomes and prognosis.
PubMed: 31507349
DOI: 10.1055/s-0039-1687835 -
Clinics in Colon and Rectal Surgery Sep 2019This article provides an overview of hidradenitis suppurativa, lichen planus, lichen sclerosis, calcinosis cuti, pyogenic granuloma, intertrigo, and seborrheic... (Review)
Review
This article provides an overview of hidradenitis suppurativa, lichen planus, lichen sclerosis, calcinosis cuti, pyogenic granuloma, intertrigo, and seborrheic keratosis. This article also focuses on recognition and management of these pleomorphic afflictions of the perianal region.
PubMed: 31507350
DOI: 10.1055/s-0039-1687836