Prevention of incisional hernia with retrorectus synthetic mesh versus biological mesh following loop ileostomy closure (Preloop trial).

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).

Synthetic mesh versus biological mesh to prevent incisional hernia after loop-ileostomy closure: a randomized feasibility trial.

BACKGROUND: Incisional hernia is a frequent complication after loop-ileostomy closure, rationalizing hernia prevention. Biological meshes have been widely used in contaminated surgical sites instead of synthetic meshes in fear of mesh related complications. However, previous studies on meshes does not support this practice. The aim of Preloop trial was to study the safety and efficacy of synthetic mesh compared to a biological mesh in incisional hernia prevention after loop-ileostomy closure. METHODS: The Preloop randomized, feasibility trial was conducted from April 2018 until November 2021 in four hospitals in Finland. The trial enrolled 102 patients with temporary loop-ileostomy after anterior resection for rectal cancer. The study patients were randomized 1:1 to receive either a light-weight synthetic polypropylene mesh (Parietene Macro™, Medtronic) (SM) or a biological mesh (Permacol™, Medtronic) (BM) to the retrorectus space at ileostomy closure. The primary end points were rate of surgical site infections (SSI) at 30-day follow-up and incisional hernia rate during 10 months' follow-up period. RESULTS: Of 102 patients randomized, 97 received the intended allocation. At 30-day follow-up, 94 (97%) patients were evaluated. In the SM group, 1/46 (2%) had SSI. Uneventful recovery was reported in 38/46 (86%) in SM group. In the BM group, 2/48 (4%) had SSI (p > 0.90) and in 43/48 (90%) uneventful recovery was reported. The mesh was removed from one patient in both groups (p > 0.90). CONCLUSIONS: Both a synthetic mesh and biological mesh were safe in terms of SSI after loop-ileostomy closure. Hernia prevention efficacy will be published after the study patients have completed the 10 months' follow-up.

Sarcopenia and Myosteatosis Are Associated with Neutrophil to Lymphocyte Ratio but Not Glasgow Prognostic Score in Colorectal Cancer Patients.

Cancer patients commonly present sarcopenia, myosteatosis, and systemic inflammation, which are risk factors of poor survival. In this study, sarcopenia and myosteatosis were defined from preoperative body computed tomography scans of 222 colorectal cancer (CRC) patients and analyzed in relation to tumor and patient characteristics, markers of systemic inflammation (modified Glasgow prognostic score (mGPS), neutrophil−lymphocyte ratio (NLR), serum levels of C-reactive protein (CRP), albumin, and 13 cytokines, and survival. Of the systemic inflammation markers, sarcopenia and/or myosteatosis associated with elevated NLR (p = 0.005) and low albumin levels (≤35 g/L) (p = 0.018), but not with mGPS or serum cytokine levels. In addition, myosteatosis was associated with a proximal tumor location (p = 0.039), serrated tumor subtype (p < 0.001), and severe comorbidities (p = 0.004). Multivariable analyses revealed that severe comorbidities and serrated histology were independent predictors of myosteatosis, and older age and elevated NLR were independent indicators of sarcopenia. Myosteatosis associated with shorter overall survival in univariable analysis (HR 1.959, 95% CI 1.24−3.10, p = 0.004) but not in multivariable analysis (p = 0.075). We conclude that sarcopenia and myosteatosis were associated with inflammatory marker NLR, but not with mGPS. Moreover, patients with serrated CRC may have an increased risk of myosteatosis. Myosteatosis or sarcopenia were not independent predictors of patient survival.

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.

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.

Anatomical and functional changes to the pelvic floor after robotic versus laparoscopic ventral rectopexy: a randomised study.

INTRODUCTION AND HYPOTHESIS: To compare the effect of laparoscopic and robot-assisted ventral rectopexy for posterior compartment procidentia on the pelvic floor anatomy and function. METHODS: A prospective randomised single-centre study was carried out of 29 female patients, who underwent robot-assisted or laparoscopic ventral mesh rectopexy for external or internal rectal prolapse with symptoms of obstructive defecation and/or faecal incontinence. Anatomical changes were measured by Pelvic Organ Prolapse Quantification (POP-Q) and magnetic resonance defecography. Functional changes were evaluated using symptom questionnaires before and 3 months after surgery. RESULTS: After rectopexy, changes in POP-Q measurements were statistically significant for points Ap, Bp, C, D and Ba. The descent of the anorectum and cervix/vaginal cuff during straining were significantly reduced with regard to the reference line (mean, -10.4 ± 14.9 mm, p = 0.001) and (-13.3 ± 18.1 mm, p < 0.001) respectively. Pelvic organ mobility (POM) was reduced statistically significantly for the posterior (mean, -16.6 ± 20.8 mm, p < 0.001) and apical compartments (mean, -13.1 ± 14.8, p < 0.001). The PFDI-20, PFIQ-7 and PISQ-12 questionnaires showed statistically significant improvement of symptoms and sexual function. No significant differences were observed between the robot-assisted and laparoscopic techniques in terms of anatomical or functional parameters. CONCLUSION: Ventral mesh recto-colpo-sacropexy effectively corrects the anatomy of the posterior compartment, elevates the vaginal apex and reduces pelvic organ mobility of the posterior and middle compartments. The robot-assisted and laparoscopic techniques had similar anatomical and functional outcomes.

Endovenous obliteration with radiofrequency-resistive heating for greater saphenous vein insufficiency: a feasibility study.

PURPOSE: To assess the feasibility, safety, and clinical utility of ultrasound (US)- and fluoroscopy-guided endovenous saphenous vein obliteration with radiofrequency (RF)-resistive heating in the treatment of primary venous insufficiency. MATERIALS AND METHODS: Thirty legs of 27 patients with mild to moderate varicose veins and primary greater saphenous vein (GSV) insufficiency diagnosed with duplex US were treated. An endovenous catheter was inserted via US-guided percutaneous puncture or a skin incision. Fluoroscopy and US were used to locate the electrodes at the saphenofemoral junction. GSVs were occluded with RF-resistive heating. Local phlebectomies or sclerotherapy were performed in all procedures to treat varicose veins and teleangiectases. Persistence of vein occlusion and complications potentially attributable to endovenous treatment were assessed at 1 week, 6 weeks, 3 months, 6 months, and 1 year. RESULTS: The mean follow-up time was 9.6 months (SD, 3.8 mo). By the time of the last follow-up visit, occlusion of the treated segment of the GSV had been achieved in 22 legs (73.3%). Persisting patency or recanalization of the GSV was detected in eight legs (26.7%). One patient (3.3%) had varicosity-related symptoms, and three treated legs (10%) had recurrent or new varicosities. Postoperative complications included saphenous nerve paresthesia in three legs (10%) and thermal skin injury in one limb (3.3%). CONCLUSION: Endovenous obliteration employing RF-resistive heating is a relatively safe and promising minimally invasive technique for the treatment of primary GSV insufficiency.