ABSTRACT
Objective:To investigate the long-term effects of porcine small intestinal submucosa (SIS) biologic mesh in open Lichtenstein tension-free hernia repair.Methods:The prospective randomized controlled study was conducted. The clinical data of 76 patients with unilateral inguinal hernia who underwent open Lichtenstein tension-free hernia repair in 2 medical centers (52 cases in Tianjin People′s Hospital and 24 cases in China-Japan Friendship Hospital) from August 2013 to March 2014 were selected. Based on random number method, patients were allocated into two groups. Patients undergoing Lichtenstein tension-free hernia repair using Biodesign Surgisis mesh were allocated into control group, and patients undergoing Lichtenstein tension-free hernia repair using SIS biologic mesh were allocated into experiment group. Observa-tion indicators: (1) grouping situations of the enrolled patients; (2) postoperative long-term effects. Follow-up was conducted using telephone interview, text message or mail to detect hernia recurrence or death due to other reasons as the end-point event of patients up to December 2019. Measurement data with normal distribution were represented as Mean± SD, and comparison between groups was conducted using the t test. Measurement data with skewed distribution were represented by M (range), and comparison between groups was conducted using the Mann-Whitney U test. Count data were described as absolute numbers, and comparison between groups was conducted using the chi-square test or Fisher exact probability. Results:(1) Grouping situations of the enrolled patients: a total of 76 patients were selected for eligibility. There were 38 cases in the control group and the experiment group, respectively. The number of males and females, age, body mass index, cases with intraspinal anesthesia or local anesthesia (anesthesia method), cases with inguinal hernia on the left side or on the right side, cases classified as type Ⅰ, Ⅱ, Ⅲ, Ⅳ or Ⅴ of Gilbert classification, operation time of the control group were 35, 3, (56±15)years, (23.0±2.0)kg/m 2, 22, 16, 16, 22, 9, 16, 0, 11, 2 and (49±15)minutes, respectively. The above indicators of the experiment group were 34, 4, (54±13)years, (22.9±2.2)kg/m 2, 17, 21, 14, 24, 9, 21, 1, 7, 0, and (53±21)minutes, respectively. There was no significant difference in the above indicators between the two groups ( χ2=0.157, t=0.532, 0.367, χ2=1.317, 0.220, Z=-0.315, t=-0.765, P>0.05). (2) Post-operative long-term effects: 35 patients of the control group were followed up for (68.8±2.7)months, 4 cases of which died due to other reasons, 1 case had hernia recurrence, 1 case had chronic pain and no foreign body sensation and postoperative infection occurred. Thirty-one patients of the experiment group were followed up for (68.8±2.7)months, with no death or above complications. There was no significant difference in hernia recurrence or chronic pain between the two groups ( P>0.05). Conclusion:The long-term effects of biological mesh in open Lichtenstein tension-free hernia repair is satisfactory and there is no difference in the long-term effects between the domestic SIS biological mesh and Biodesign Surgisis mesh.
ABSTRACT
Resumen ANTECEDENTE: el tratamiento de una fístula genitourinaria compleja es un reto por las múltiples dificultades para conseguir un resultado exitoso; el injerto biológico de intestino porcino puede ser una opción en estos casos. OBJETIVO: describir el diagnóstico de las fístulas genito-urinarias y su reparación con una innovadora interposición de injerto biológico de intestino delgado porcino. MATERIALES Y MÉTODOS: estudio prospectivo de serie de casos con diagnóstico de fístula vésico-vaginal y uretro-vaginal de pacientes atendidas en el Instituto Nacional de Perinatología entre los años 2012 a 2014. Descripción de los datos demográficos de cada paciente, proceso diagnóstico-clínico y estudios de gabinete y laboratorio; características de la fístula, técnica quirúrgica y seguimiento. RESULTADOS: se estudiaron 5 pacientes con fístulas tipo III o vésico-vaginales localizadas en el trígono, 3 de ellas relacionadas con cirugía ginecológica y 2 con un evento obstétrico, y una tipo I o uretrovaginal en la uretra proximal, relacionada con parto instrumentado. En el cierre del segundo plano, para la colocación del injerto biológico, se aplicó la técnica de reparación de Latzko modificada. Una paciente tuvo 4 reparaciones previas, otra una reparación previa y el resto ninguna. El tamaño varió de 0.5 cm a 3 cm. El seguimiento posoperatorio no evidenció recurrencia; una paciente tuvo incontinencia urinaria de esfuerzo un año después. El seguimiento mínimo fue de 1 y el máximo de 2 años. No se registraron complicaciones posoperatorias. CONCLUSIÓN: el injerto de mucosa de intestino delgado porcino para la reparación de fístulas urogenitales complejas y recurrentes fue efectivo en todas las pacientes.
Abstract BACKGROUND: treatment of a complex genitourinary fistula is a challenge given the multiple difficulties to achieve a successful result, the biological grafting of porcine intestine can be an option in these cases. OBJECTIVE: to describe the diagnosis of genitourinary fistulas and their repair with an innovative interposition of small intestine porcine biological graft. MATERIALS AND METHODS: a prospective trial of a series of cases with a diagnosis of vesicovaginal and urethrovaginal fistula in patients of the Instituto Nacional de Perinatología between 2012 to 2014. Description of patient demographics, diagnostic and clinical process, imaging and lab tests; characteristics of the fistula, surgical technique and follow up. RESULTS: 5 patients with type III or vesicovaginal fistulas located in the trigone were studied, 3 of the fistulas are related to gynecological surgery and 2 with an obstetric event and one type 1 or urethrovaginal in the proximal urethra caused by an instrumented delivery. In the closure of the second layer for placement of the biological graft, we applied the modified Latzko repair technique. One patient had 4 previous repairs, another one had one previous repair and the rest had none. The size varied from 0.5 cm to 3 cm. The postoperative follow-up period did not show recurrence; one patient had stress urinary incontinence one year later. The minimum follow-up was 1 year and the maximum 2 years. No postoperative complications were reported. CONCLUSION: the porcine small intestinal submucosa graft for the repair of complex and recurrent urogenital fistulas was effective in all patients.