RESUMO
BACKGROUND: The rate of incisional hernia after closure of a temporary loop ileostomy is significant. Synthetic meshes are still commonly avoided in contaminated wounds. The Preloop trial was a multicentre RCT designed to evaluate the benefits of synthetic mesh in incisional hernia prevention, and its safety for use in a contaminated surgical site compared with biological mesh. METHODS: Study patients who underwent closure of a loop ileostomy after anterior resection for rectal cancer were assigned to receive either retrorectus synthetic or biological mesh to prevent incisional hernia. The primary outcomes were surgical-site infections within 30 days, and clinical or radiological incisional hernia incidence at 10 months. Secondary outcomes were reoperation rate, operating time, duration of hospital stay, other complications within 30 days of surgery, 5-year quality of life measured by RAND-36, and incisional hernia incidence within 5 years of follow-up. RESULTS: Between November 2018 and September 2021, 102 patients were randomised, of whom 97 received the intended allocation. At 10-month follow-up, 90 patients had undergone clinical evaluation and 88 radiological evaluation. One patient in each group (2 per cent) had a clinical diagnosis of incisional hernia (P = 0.950) and one further patient in each group had a CT-confirmed incisional hernia (P = 0.949). The number of other complications, reoperation rate, operating time, and duration of hospital stay did not differ between the study groups. CONCLUSION: Synthetic mesh appeared comparable to biological mesh in efficacy and safety for incisional hernia prevention at the time of loop ileostomy closure. REGISTRATION NUMBER: NCT03445936 (http://www.clinicaltrials.gov).
Assuntos
Hérnia Incisional , Humanos , Ileostomia/efeitos adversos , Hérnia Incisional/etiologia , Hérnia Incisional/prevenção & controle , Hérnia Incisional/epidemiologia , Qualidade de Vida , Telas Cirúrgicas/efeitos adversos , Infecção da Ferida Cirúrgica/etiologia , Infecção da Ferida Cirúrgica/prevenção & controleRESUMO
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 PROTÉSICA PARA PREVENIR UNA HERNIA PARAESTOMAL EN UNA COLOSTOMÍA PERMANENTE: RESULTADOS DE UN SEGUIMIENTO A LARGO PLAZO: PREVENCIÓN DE HERNIA PARAESTOMAL, NEOPLASIA COLORRECTAL/ANAL: Las hernias paraestomales son comunes con colostomías permanentes y son propensas a complicaciones. Los resultados a corto plazo de los ensayos sobre la prevención 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 realizó en dos hospitales universitarios y tres hospitales centrales en Finlandia.Los pacientes que se sometieron a una resección abdominoperineal laparoscópica por cáncer de recto 2010-2013 fueron incluidos en el estudio e invitados a una visita de seguimiento.Hernias parastomales clínicas y radiológicas.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 clínicamente 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 radiológica 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 período de seguimiento (p = 0,10). Además, solo 1/35 (2.7%) en el grupo de malla pero 6/35 (17.1%) en el grupo control se sometieron a una operación de hernia paraestomal durante el seguimiento a largo plazo (p = 0.030).El estudio está limitado por un pequeño número de pacientes.La malla intra-abdominal profiláctica en ojo de cerradura no disminuyó la tasa de hernias clínicamente detectables, pero redujo la necesidad de la reparación quirúrgica de las hernias paraestomales. Se necesitan ensayos adicionales para identificar un método más eficiente para prevenir las hernias parastomales. Vea el resumen del video en http://links.lww.com/DCR/B171. (Traducción-Dr. Gonzalo Hagerman).NCT02368873.
Assuntos
Colostomia/efeitos adversos , Hérnia Incisional/prevenção & controle , Protectomia/efeitos adversos , Neoplasias Retais/cirurgia , Telas Cirúrgicas , Estomas Cirúrgicos/efeitos adversos , Idoso , Feminino , Finlândia , Seguimentos , Humanos , Laparoscopia/efeitos adversos , Masculino , Pessoa de Meia-Idade , Estudos ProspectivosRESUMO
BACKGROUND: Due to faster recovery and lower morbidity rates, laparoscopy has become the gold standard in elective colorectal surgery for both the benign and malignant forms of the disease. A substantial proportion of colorectal operations are, however, carried out in emergency settings, and most of the emergency resections are still performed open. The aim of this study is to compare the laparoscopic versus open approach for emergency colorectal surgery. METHOD/DESIGN: This is a multicenter prospective randomized controlled trial including adult patients presenting with a condition requiring emergency colorectal resection. DISCUSSION: Previous studies cautiously recommend wider use of laparoscopy in emergency colorectal resections, but all earlier reports are retrospective, are mostly single-center studies, and have limited numbers of patients. Laparoscopy may involve some unpredictable risks that have not yet been reported because of the infrequent use of the techniqueded to assess the safety of laparoscopy as well as the advantages and disadvantages of open compared with laparoscopic emergency surgery. TRIAL REGISTRATION: Trial registration number: ClinicalTrials.gov NCT05005117 . Registered on August 12, 2021.
Assuntos
Neoplasias Colorretais , Laparoscopia , Adulto , Humanos , Colectomia/métodos , Neoplasias Colorretais/cirurgia , Laparoscopia/métodos , Estudos Multicêntricos como Assunto , Estudos Prospectivos , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do TratamentoRESUMO
Postoperative intraabdominal adhesions cause morbidity of varying degree. Intestinal obstruction is the most severe complication of adhesions. This study examined the importance of previous surgery on clinical and economic workloads caused by intestinal obstruction due to postoperative intraabdominal adhesions. All emergency hospitalizations due to adhesion-related intestinal obstruction from January 1, 1999 to December 31, 1999 in a hospital district serving roughly 450,000 inhabitants was reviewed retrospectively. The patient population was divided into six groups according to the site of previous surgery, and the total as well as group-related surgical workload and direct costs of inpatient care were analyzed. There were 123 hospitalizations due to postoperative adhesion-related intestinal obstruction during the study period. A total of 101 patients had experienced 176 operations. The most prevalent operations were colorectal (with or without other operations), upper abdominal, and female reproductive system procedures. Colorectal surgery preceded 40% and 38% of inpatient episodes and inpatient days, respectively. Altogether, 40 operations were performed because of adhesion-related intestinal obstruction. No differences between groups were seen in terms of the mean operating or theater time. Total annual inpatient costs due to emergency hospitalizations for intestinal adhesion-related obstruction related to colorectal surgery in a hospital district serving roughly 450,000 inhabitants was 72,520.60 (U.S. dollars) which accounted for 35.3% of all annual costs caused by postoperative adhesion-related intestinal obstructions. There were no significant differences between groups regarding the total mean inpatient episode costs. Intestinal obstruction due to postoperative adhesions poses substantial costs for the society. Colorectal operations are the most important procedures preceding adhesion-related intestinal obstruction, accounting for 35.3% to 46.8% of the total clinical workload or costs attributable to postoperative adhesion-related obstruction.