de la Portilla F, Reyes-Díaz M L, Maestre M V, Jiménez-Rodríguez R M, García-Cabrera A M, Vázquez-Monchul J M, Díaz-Pavón J M, Padillo-Ruiz F C
Coloproctology Unit. Clinical Management Unit of General and Gastrointestinal Surgery Division, Seville Biomedical Research Institute (IBIS). University Hospital Virgen del Rocío/CSIC/University of Seville, Avda Manuel Siurot s/n, 41013, Seville, Spain.
Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD o Ciberehd), Instituto de Salud Carlos III, Madrid, Spain.
Int J Colorectal Dis. 2017 Mar;32(3):437-440. doi: 10.1007/s00384-016-2742-z. Epub 2017 Jan 4.
Faecal incontinence (FI) is both a medical and social problem, with an underestimated incidence. For patients with internal anal sphincter damage, implantation of biomaterial in the anal canal is a recognised treatment option. One such material, Gatekeeper™, has previously shown promising short- and medium-term results without any major complications, including displacement. The main aim of the present study is to assess the degree to which displacement of Gatekeeper prostheses may occur and to determine whether this is associated with patient outcomes.
Seven patients (six females) with a mean age of 55.6 years [50.5-57.2] and a mean FI duration of 6 ± 2 years were prospectively enrolled in the study. Each subject was anaesthetised and underwent implantation of six prostheses in the intersphincteric region, guided by endoanal 3D ultrasound (3D-EAU). Follow-up was performed at post-interventional months 1, 3, and 12 (median 12 ± 4 months), during which data were obtained from a defaecation diary, Wexner scale assessment, anorectal manometry (ARM), 3D-EAU, and a health status and quality of life questionnaire (FIQL).
At 3-month follow-up, 3D-EAU revealed displacement of 24/42 prostheses in 5/7 patients. Of these, 15 had migrated to the lower portion and 9 to the upper portion of the anal canal and rectum. Despite this migration, treatment was considered successful in 3/7 patients. In one patient, it was necessary to remove a prosthesis due to spontaneous extrusion.
We have shown that displacement of the Gatekeeper™ prosthesis occurs, but is not associated with poorer clinical outcomes.
大便失禁（FI）既是一个医学问题，也是一个社会问题，其发病率被低估。对于肛门内括约肌受损的患者，在肛管内植入生物材料是一种公认的治疗选择。一种这样的材料，Gatekeeper™，此前已显示出有希望的短期和中期结果，且无任何重大并发症，包括移位。本研究的主要目的是评估Gatekeeper假体移位可能发生的程度，并确定这是否与患者的预后相关。
前瞻性纳入7例患者（6例女性），平均年龄55.6岁[50.5 - 57.2]，平均大便失禁持续时间为6±2年。每位受试者接受麻醉，并在内肛管三维超声（3D-EAU）引导下，在括约肌间区域植入6个假体。在介入后第1、3和12个月（中位时间12±4个月）进行随访，期间从排便日记、韦克斯纳量表评估、肛肠测压（ARM）、3D-EAU以及健康状况和生活质量问卷（FIQL）中获取数据。
在3个月的随访中，3D-EAU显示7例患者中有5例的42个假体中有24个发生移位。其中，15个迁移到肛管和直肠的下部，9个迁移到上部。尽管发生了这种移位，但7例患者中有3例的治疗被认为是成功的。在1例患者中，由于假体自发脱出，有必要取出一个假体。
我们已经表明，Gatekeeper™假体发生移位，但与较差的临床结果无关。
