Prospective, Randomized Study on the Use of Prosthetic Mesh to Prevent a Parastomal Hernia in a Permanent Colostomy: Results of a Long-term Follow-up
| Autor: | Mika T Vierimaa, Elisa Mäkäräinen-Uhlbäck, Tero Rautio, Pasi Ohtonen, Jyrki Kössi, Monika Carpelan-Holmström, Matti V. Kairaluoma, Kai Klintrup, Pirita R Tahvonen |
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| Rok vydání: | 2020 |
| Předmět: |
Male
medicine.medical_specialty Long term follow up Parastomal hernia 03 medical and health sciences 0302 clinical medicine Permanent colostomy Colostomy medicine Humans Incisional Hernia Hernia Prospective randomized study Prospective Studies Finland Aged Gynecology Proctectomy Rectal Neoplasms business.industry Abdominoperineal resection Gastroenterology Surgical Stomas General Medicine Middle Aged Surgical Mesh University hospital medicine.disease 3. Good health Estudio prospectivo 030220 oncology & carcinogenesis Female Laparoscopy 030211 gastroenterology & hepatology business Follow-Up Studies |
| Zdroj: | Diseases of the Colon & Rectum. 63:678-684 |
| ISSN: | 0012-3706 |
| Popis: | Background Parastomal hernias are common with permanent colostomies and prone to complications. The short-term results of trials of parastomal hernia prevention are widely published, but long-term results are scarce. Objective The aim of the study is to detect the long-term effects and safety of preventive intra-abdominal parastomal mesh. Design This is a long-term follow-up of a previous prospective randomized, controlled multicenter trial. Settings This study was conducted at 2 university hospitals and 3 central hospitals in Finland. Patients Patients who had a laparoscopic abdominoperineal resection for rectal cancer between 2010 and 2013 were included in the study and invited for a follow-up visit. Main outcome measures The primary outcomes measured were clinical and radiological parastomal hernias. Results Twenty subjects in the mesh group and 15 in the control group attended the follow-up visit with a median follow-up period of 65 (25th-75th percentiles, 49-91) months. A clinically detectable parastomal hernia was present in 4 of 20 (20.0%) and 5 of 15 (33.3%) subjects in the mesh and control groups (p = 0.45). A radiological parastomal hernia was present in 9 of 19 (45.0%) subjects in the mesh group and 7 of 12 (58.3%) subjects in the control group (p = 0.72). However, when all subjects (n = 70, 1:1) who attended the 12-month follow-up were screened for long-term results according to register data, 9 of 35 (25.9%) subjects in the mesh group and 16 of 35 (45.6%) subjects in control group were diagnosed with a parastomal hernia during the follow-up period (p = 0.10). In addition, only 1 of 35 (2.7%) subjects in the mesh group but 6 of 35 (17.1%) subjects in the control group underwent a parastomal hernia operation during the long-term follow-up (p = 0.030). Limitations The study is limited by the small number of patients. Conclusion Prophylactic intra-abdominal keyhole mesh did not decrease the rate of clinically detectable hernias but reduced the need for the surgical repair of parastomal hernias. Further trials are needed to identify a more efficient method to prevent parastomal hernias. See Video Abstract at http://links.lww.com/DCR/B171. Clinical trial registration https://clinicaltrials.gov. Identifier: NCT02368873. ESTUDIO PROSPECTIVO ALEATORIZADO SOBRE EL USO DE MALLA PROTESICA PARA PREVENIR UNA HERNIA PARAESTOMAL EN UNA COLOSTOMIA PERMANENTE: RESULTADOS DE UN SEGUIMIENTO A LARGO PLAZO: PREVENCION DE HERNIA PARAESTOMAL, NEOPLASIA COLORRECTAL/ANAL: Las hernias paraestomales son comunes con colostomias permanentes y son propensas a complicaciones. Los resultados a corto plazo de los ensayos sobre la prevencion de la hernia parastomal se publican ampliamente, pero los resultados a largo plazo son escasos.El objetivo del estudio es detectar los efectos a largo plazo y la seguridad de la malla parastomal intraabdominal preventiva.Este es un seguimiento a largo plazo de un estudio aleatorizado prospectivo, controlado y multicentrico previo.Este estudio se realizo en dos hospitales universitarios y tres hospitales centrales en Finlandia.Los pacientes que se sometieron a una reseccion abdominoperineal laparoscopica por cancer de recto 2010-2013 fueron incluidos en el estudio e invitados a una visita de seguimiento.Hernias parastomales clinicas y radiologicas.Veinte sujetos en el grupo de malla y 15 en el grupo control asistieron a la visita de seguimiento con una mediana de seguimiento de 65 meses (25-75 ° percentil 49-91). Una hernia paraestomal clinicamente detectable estuvo presente en 4/20 (20.0%) y 5/15 (33.3%) en los grupos de malla y control, respectivamente (p = 0.45). Una hernia parastomal radiologica estuvo presente en 9/19 (45.0%) en el grupo de malla y 7/12 (58.3%) en el grupo de control (p = 0.72). Sin embargo, cuando todos los sujetos (n = 70, 1: 1) que asistieron a los 12 meses de seguimiento fueron evaluados para obtener resultados a largo plazo de acuerdo con los datos del registro, 9/35 (25.9%) sujetos en el grupo de malla y 16/35 (45,6%) sujetos en el grupo control fueron diagnosticados con una hernia paraestomal durante el periodo de seguimiento (p = 0,10). Ademas, solo 1/35 (2.7%) en el grupo de malla pero 6/35 (17.1%) en el grupo control se sometieron a una operacion de hernia paraestomal durante el seguimiento a largo plazo (p = 0.030).El estudio esta limitado por un pequeno numero de pacientes.La malla intra-abdominal profilactica en ojo de cerradura no disminuyo la tasa de hernias clinicamente detectables, pero redujo la necesidad de la reparacion quirurgica de las hernias paraestomales. Se necesitan ensayos adicionales para identificar un metodo mas eficiente para prevenir las hernias parastomales. Vea el resumen del video en http://links.lww.com/DCR/B171. (Traduccion-Dr. Gonzalo Hagerman).NCT02368873. |
| Databáze: | OpenAIRE |
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