mesh

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  • 文章类型: Journal Article
    BACKGROUND: Laparoscopic repair of large para-esophageal hiatal hernias (LPHH) remains controversial. Several meta-analyses suggest hiatus reinforcement with mesh has better outcomes over cruroplasty in terms of less recurrence. The aim of this study was to evaluate the medium-term results of treating LPHH with a biosynthetic monofilament polypropylene mesh coated with titanium dioxide to enhance biocompatibility (TiO2Mesh™).
    METHODS: A retrospective observational study, using data extracted from a prospectively collected database was performed at XXX from December 2014 to June 2023. Included participants were all patients who underwent laparoscopic repair of large (> 5 cm) type III hiatal hernia in which a TiO2Mesh™ was used. The results of the study, including clinical and radiological recurrences as well as mesh-related morbidity, were analyzed.
    RESULTS: Sixty-seven patients were finally analyzed. Laparoscopic approach was attempted in all but conversion was needed in one patient because of bleeding in the lesser curvature. With a median follow-up of 41 months (and 10 losses to follow-up), 22% of radiological recurrences and 19.3% of clinical recurrences were described. Regarding complications, one patient presented morbidity associated with the mesh (mesh erosion requiring endoscopic extraction). Recurrent hernia repair was an independent factor of clinical recurrence (OR 4.57 95% CI (1.28-16.31)).
    CONCLUSIONS: LPHH with TiO2Mesh™ is safe and feasible with a satisfactory medium-term recurrence and a low complication rate. Prospective randomized studies are needed to establish the standard repair of LPHH.
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  • 文章类型: Journal Article
    OBJECTIVE: Recent guidelines indicate the use of mesh in UHR for defects > 1 cm, as it reduces recurrence, with 10% recurrence rate compared to up to 54.5% with primary closure. However, Nguyen et al. shows that primary closure is still widely performed in UHR, especially for small defects (1-2 cm), for which there is no published data to determine the optimal approach. In addition, previous meta-analysis by Madsen et al. comparing mesh repair with primary closure in UHR didn\'t exclude emergency conditions and recurrent hernias; also, didn\'t report subgroup analysis on hernia defect size. Thus, we aimed to perform a systematic review and meta-analysis comparing the mesh repairs vs. primary closure of the defect in an open elective primary UHR.
    METHODS: We searched for studies comparing mesh with suture in open UHR in PubMed, Scopus, Cochrane, Scielo, and Lilacs from inception until October 2023. Studies with patients ≤ 18 years old, with recurrent or emergency conditions were excluded. Outcomes were recurrence, seroma, hematoma, wound infection, and hospital length of stay. Subgroup analysis was performed for: (1) RCTs only, and (2) hernia defects smaller than 2 cm. We used RevMan 5.4. for statistical analysis. Heterogeneity was assessed with I² statistics, and random effect was used if I² > 25%.
    RESULTS: 2895 studies were screened and 56 were reviewed. 12 studies, including 4 RCTs, 1 prospective cohort, and 7 retrospective cohorts were included, comprising 2926 patients in total (47.6% in mesh group and 52.4% in the suture group). Mesh repair showed lower rates of recurrence in the overall analysis (RR 0.50; 95% CI 0.31 to 0.79; P = 0.003; I2 = 24%) and for hernia defects smaller than 2 cm (RR 0.56; 95% CI 0.34 to 0.93; P = 0.03; I2 = 0%). Suture repair showed lower rates of seroma (RR 1.88; 95% CI 1.07 to 3.32; P = 0.03; I2 = 0%) and wound infection (RR 1.65; 95%CI 1.12 to 2.43; P = 0.01; I2 = 15%) in the overall analysis, with no differences after performing subgroup analysis of RCTs. No differences were seen regarding hematoma and hospital length of stay.
    CONCLUSIONS: The use of mesh during UHR is associated with significantly lower incidence of recurrence in a long-term follow-up compared to the suture repair, reinforcing the previous indications of the guidelines. Additionally, despite the overall analysis showing higher risk of seroma and wound infection for the suture repair, no differences were seen after subgroup analysis of RCTs.
    BACKGROUND: A review protocol for this systematic review and meta-analysis was registered at PROSPERO (CRD42024476854).
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  • 文章类型: Journal Article
    背景:微创腹股沟疝修补术后的慢性疼痛会对生活质量(QOL)产生衰弱影响,限制日常活动和工作能力。已经提出了许多医疗和手术治疗方案,然而,对于网状物移植在这些患者的治疗中的作用尚无共识。
    方法:我们对2012年7月至2023年7月在我们机构接受了通过机器人或腹腔镜方法去除腹股沟网状物的所有患者进行了回顾性审查。术后对患者进行访谈以确定其总体疼痛评分,并使用CarolinasComfortScale(CCS)问卷评估QOL。患者特征,手术时间,还记录了术前成像技术和镇痛使用情况.
    结果:22例慢性疼痛患者行腹股沟网片摘除术,包括12个机器人和10个腹腔镜手术。所有患者术前平均疼痛评分为7.6/10,术后为4.0/10。术后CCS平均评分为24分,表明中度不适。四名患者表现出CCS评分<11,表明没有不适,并且没有患者表现出CCS评分>90,表明严重的衰弱不适。大多数患者术后镇痛摄入量减少或完全停止。
    结论:腹腔镜和机器人网状移植治疗腹股沟疝修补术后慢性疼痛在减轻疼痛和减少长期镇痛方面都是安全有效的。
    BACKGROUND: Chronic pain after minimally invasive inguinal hernia repair with mesh can have debilitating effects on quality of life (QOL), limiting daily activities and ability to work. Many medical and surgical options for treatment have been proposed, however there is no consensus on the role of mesh explantation in the management of these patients.
    METHODS: We performed a retrospective review of all patients who underwent groin mesh removal by robotic or laparoscopic approach from July 2012 to July 2023 at our institution. Patients were interviewed post-operatively to determine their overall pain scores and QOL was assessed using the Carolinas Comfort Scale (CCS) Questionnaire. Patient characteristics, operative times, pre-operative imaging techniques and analgesia use was also recorded.
    RESULTS: Twenty-two patients underwent groin mesh removal for chronic pain, including 12 robotic and 10 laparoscopic operations. The mean pre-operative pain score in all patients was 7.6/10 compared to 4.0/10 post-operatively. The mean post-operative CCS score was 24, indicating moderate discomfort. Four patients demonstrated CCS scores <11 indicating no discomfort and no patients demonstrated CCS scores >90, indicating severe debilitating discomfort. The majority of patients had a reduction or total cessation of analgesia intake post-operatively.
    CONCLUSIONS: Both laparoscopic and robotic mesh explantation for treatment of chronic pain post-inguinal hernia repair is safe and effective in achieving a reduction in pain and reducing the need for long-term analgesia.
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  • 文章类型: Journal Article
    简介:钛基植入物可用于填充骨重建手术中的空隙。通过增材制造(AM),有可能生产具有骨传导性能如高孔隙率和低刚度的钛植入物。AM促进了传统技术不可行的设计灵活性和个性化水平。方法:在本研究中,植入后12周,使用新型双皮质承载绵羊模型研究了骨整合到钛合金(Ti-6Al-4V)晶格中。目的是使用跨越股骨髁整个宽度的对比刚度的两种晶格结构来评估AM制造的植入物的安全性和有效性。结果:这是通过组织形态计量学评估植入物骨整合和骨-植入物接触特性来实现的,通过组织病理学对局部植入物组织反应进行评分,和显微计算机断层扫描重建。讨论:我们发现Ti-6Al-4V植入物促进了广泛和广泛的骨整合,在试验期结束时,骨骼正在成熟。植入期之后,没有发现可直接归因于植入装置存在的不良临床适应症,通过宏观和微观观察确定。
    Introduction: Titanium-based implants can be used to fill voids in bone reconstruction surgery. Through additive manufacturing (AM), it is possible to produce titanium implants with osteoconductive properties such as high porosity and low stiffness. AM facilitates a level of design flexibility and personalization that is not feasible with traditional techniques. Methods: In this study, osseointegration into titanium alloy (Ti-6Al-4V) lattices was investigated for 12 weeks post-implantation using a novel bicortical load-bearing ovine model. The objective was to assess the safety and efficacy of AM-fabricated implants using two lattice structures of contrasting stiffness spanning the full width of the femoral condyle. Results: This was achieved by evaluating implant osseointegration and bone-implant contact properties by histomorphometry, scoring local implant tissue responses via histopathology, and micro-computed tomography reconstruction. Discussion: We found that Ti-6Al-4V implants facilitated widespread and extensive osseointegration, with bone maturation ongoing at the conclusion of the trial period. Following the implantation period, no adverse clinical indications that could be directly ascribed to the presence of the implanted device were identified, as determined by macroscopic and microscopic observation.
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  • 文章类型: Case Reports
    放线菌病是一种罕见的,由放线菌引起的慢性细菌感染。虽然它通常影响颈面部区域,胸部,和腹部,阑尾受累极为罕见.此案例报告详细介绍了演示文稿,诊断,以及一名45岁女性放线菌病继发急性阑尾炎患者的治疗。
    方法:一个45岁的女人,有8年宫内节育器病史,出现三天的右髂窝疼痛,呕吐,和稳定的生命体征。实验室检查显示有炎症综合征。怀疑急性阑尾炎,CT扫描证实10毫米阑尾肿胀。腹腔镜手术显示阑尾有痰,导致简单的阑尾切除术.病理检查证实放线菌颗粒,支持放线菌阑尾炎的诊断。该患者每天接受18百万单位青霉素G静脉注射,持续6周,随后口服阿莫西林6个月疗程(1克,每日3次),表现出良好的进展,没有症状。1年后观察正常临床及超声随访。
    阑尾放线菌病是一种罕见的疾病。女人,尤其是那些有宫内避孕药的人,由于慢性炎症而导致病例增加。通常诊断不足,放线菌病模仿其他条件,表现为非特异性症状。实验室结果提供有限的帮助,组织学确认至关重要。组织病理学检查是诊断确认的必要条件。管理包括手术切除和长期青霉素抗生素,提供良好的预后,死亡率低。
    结论:这个案例强调了考虑罕见病因的重要性,如放线菌病,在阑尾炎的鉴别诊断中。及时的识别和管理对于最佳的患者预后至关重要。
    UNASSIGNED: Actinomycosis is a rare, chronic bacterial infection caused by Actinomyces species. While it commonly affects the cervicofacial region, thorax, and abdomen, appendicular involvement is extremely uncommon. This case report details the presentation, diagnosis, and management of a 45-year-old female patient with acute appendicitis secondary to actinomycosis.
    METHODS: A 45-year-old woman, with an 8-year intrauterine device history, presented with three-day right iliac fossa pain, vomiting, and stable vital signs. Laboratory tests revealed an inflammatory syndrome. Suspecting acute appendicitis, a CT scan confirmed a swollen 10 mm appendix. Laparoscopic surgery revealed a phlegmonous appendix, leading to an uncomplicated appendectomy. Pathological examination confirmed actinomycotic granules, supporting the diagnosis of actinomycosis appendicitis. The patient received 18 million units of intravenous penicillin G daily for 6 weeks followed by a 6-month course of oral amoxicillin (1 g three times daily) thereafter, showing favorable progression with no symptoms. Normal clinical and ultrasound follow-ups were observed at one year.
    UNASSIGNED: Appendiceal actinomycosis is a rare condition. Women, especially those with intrauterine contraceptives, experience an increase in cases due to chronic inflammation. Typically underdiagnosed, actinomycosis mimics other conditions, presenting with nonspecific symptoms. Laboratory results offer limited assistance, and histological confirmation is crucial. Histopathological examination is mandatory for diagnosis confirmation. Management involves surgical resection and prolonged penicillin-based antibiotics, providing a favorable prognosis with low mortality.
    CONCLUSIONS: This case underscores the importance of considering rare etiologies, such as actinomycosis, in the differential diagnosis of appendicitis. Timely recognition and management are crucial for optimal patient outcomes.
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  • 文章类型: Journal Article
    为了克服体素类型的参考计算体模(VRCP)由于有限的体素分辨率和体素几何性质的固有局限性,国际放射防护委员会(ICRP)开发了成年男性和女性网状型参考计算幻影(MRCP)。我们以前使用MRCP来计算光子和电子的理想化外部暴露的一组完整的剂量系数(DC)(Yeom等人。NET在新闻中)。在本研究中,我们将先前的研究扩展到包括额外的辐射粒子(中子,质子,和氦离子)通过使用Geant4代码进行蒙特卡罗辐射传输模拟进入DC库。将基于MRPC的DC与基于ICRPVRCP的ICRP出版物116的现有参考DC进行比较,以研究新网格类型参考体模对DC值的影响。我们发现,MRCP通常提供与VRCP类似的器官/组织剂量和有效剂量的DC,用于穿透辐射(不带电粒子),而对于弱穿透性辐射(带电粒子)观察到显着的DC差异,这主要是由于在VRCP上的MRCP中详细解剖结构的表现得到了改善。
    To overcome inherent limitations of the Voxel-type Reference Computational Phantoms (VRCPs) due to the limited voxel resolutions and the nature of voxel geometry, the International Commission on Radiological Protection (ICRP) has developed the adult male and female Mesh-type Reference Computational Phantoms (MRCPs). We previously used the MRCPs to calculate a complete set of dose coefficients (DCs) for idealized external exposures of photons and electrons (Yeom et al. NET in press). In the present study, we extended the previous study to include additional radiation particles (neutrons, protons, and helium ions) into the DC library by conducing Monte Carlo radiation transport simulations with the Geant4 code. The MRPC-based DCs were compared with the existing reference DCs of ICRP Publication 116 which are based on the ICRP VRCPs to investigate impact of the new mesh-type reference phantoms on the DC values. We found that the MRCPs generally provide DCs of organ/tissue doses and effective doses similar to those from the VRCPs for penetrating radiations (uncharged particles), whereas significant DC differences were observed for weakly penetrating radiations (charged particles) mainly due to the improved representation of the detailed anatomical structures in the MRCPs over the VRCPs.
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  • 文章类型: Journal Article
    背景:重症肢体缺血患者的最佳血管内治疗与最佳外科治疗(BEST-CLI)试验结果表明,在患有慢性威胁肢体缺血(CLTI)和足够单段大隐静脉(SSGSV)的患者中,手术优先治疗策略优于血管内优先治疗策略.然而,在实际临床实践中,尚不清楚CLTI在血管内首次血运重建之前使用静脉标测的情况.
    方法:来自多中心临床数据仓库(2008-2019)的数据与接受腔内先行治疗腹股沟下CLTI的患者的Medicare索赔数据相关联。仅包括原本有资格参加BEST-CLI的患者。足够的SSGSV被定义为从腹股沟到膝盖的直径>3.0mm的健康静脉。使用Logistic回归估计术前特征与静脉映射之间的关联。生存方法用于估计主要不良肢体事件和死亡的风险。
    结果:共有142名接受手术或血管内治疗的患者接受了CLTI的血管内治疗。在血管内首次血运重建之前,未对76%的患者进行SSGSV的超声评估。在那些接受了术前静脉标测的人中,44%有足够的SSGSV用于旁路。术后一年内,12.0%(95%置信区间7.4-18.0%)的患者接受了开放手术旁路手术,54.7%(95%置信区间45.3-62.4%)的患者发生了严重的不良肢体事件或死亡。
    结论:在接受腹股沟下CTI血管内先行干预的BEST-CLI合格患者的现实队列中,四分之三的患者没有术前超声评估大隐静脉导管.现实世界中静脉导管评估的实践模式需要在BEST-CLI试验结果的背景下重新考虑。
    BACKGROUND: The Best Endovascular versus Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) trial results suggest that in patients with chronic limb-threatening ischemia (CLTI) and adequate single-segment great saphenous vein (SSGSV) by preoperative duplex ultrasonography, a surgical-first treatment strategy is superior to an endovascular-first strategy. However, the utilization of vein mapping prior to endovascular-first revascularization for CLTI in actual clinical practice is not known.
    METHODS: Data from a multicenter clinical data warehouse (2008-2019) were linked to Medicare claims data for patients undergoing endovascular-first treatment of infra-inguinal CLTI. Only patients who would have otherwise been eligible for enrollment in BEST-CLI were included. Adequate SSGSV was defined as healthy vein >3.0 mm in diameter from the groin through the knee. Logistic regression was used to estimate associations between preprocedure characteristics and vein mapping. Survival methods were used to estimate the risk of major adverse limb events and death.
    RESULTS: A total of 142 candidates for either surgical or endovascular treatment underwent endovascular-first management of CLTI. Ultrasound assessment for SSGSV was not performed in 76% of patients prior to endovascular-first revascularization. Of those who underwent preprocedure vein mapping, 44% had adequate SSGSV for bypass. Within one year postprocedure, 12.0% (95% confidence interval 7.4-18.0%) of patients underwent open surgical bypass and 54.7% (95% confidence interval 45.3-62.4%) experienced a major adverse limb event or death.
    CONCLUSIONS: In a real-world cohort of BEST-CLI-eligible patients undergoing endovascular-first intervention for infra-inguinal CLTI, three-quarters of patients had no preprocedure ultrasound assessment of great saphenous vein conduit. Practice patterns for vein conduit assessment in the real-world warrant reconsideration in the context of BEST-CLI trial results.
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  • 文章类型: Journal Article
    背景:本研究探讨了在开放根治性膀胱切除术和回肠导管改道期间预防性网状物植入在预防造口旁疝(PH)中的疗效。尽管PH是常见的并发症,预防方法的开发不足。
    方法:一名飞行员,单中心,前瞻性队列研究涉及5例接受网状物植入手术的患者。监测人口统计学和临床特征,包括PH的发生率,操作时间,失血,和住院时间。
    结果:在术后9.1±3.2个月的平均随访期间,在患者组中未观察到PH的发生。尽管在涉及小肠开放的手术区域植入异物存在风险,未发现感染并发症.
    结论:根治性膀胱切除术中的预防性网状物植入回肠导管分流似乎是预防PH的有效措施。需要进一步的广泛研究来明确确认在这种情况下使用网状物的有效性和安全性。
    BACKGROUND: This study examines the efficacy of prophylactic mesh implantation during open radical cystectomy with ileal conduit diversion in preventing parastomal hernias (PH). Despite PH being a common complication, prophylactic methods have been underexplored.
    METHODS: A pilot, single-center, prospective cohort study was conducted involving five patients undergoing surgery with mesh implantation. Demographic and clinical characteristics were monitored, including the incidence of PH, operation time, blood loss, and hospitalization duration.
    RESULTS: During the mean follow-up period of 9.1±3.2 months post-operation, no occurrences of PH were observed in the patient group. Despite the risks associated with implanting foreign material in an area of surgery involving open small intestine, no infectious complications were noted.
    CONCLUSIONS: Prophylactic mesh implantation in radical cystectomy with ileal conduit diversion appears to be an effective preventive measure against PH. Further extensive studies are required to definitively confirm the efficacy and safety of mesh use in this context.
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  • 文章类型: Journal Article
    目的:评价膨体聚四氟乙烯(ePTFE)网片在胸壁重建中的成功。
    方法:我们回顾性分析了接受ePTFE(Gore-Tex®)胸壁重建的患者。主要结果是与网格相关的事件,定义为与网格相关的重新操作(例如,需要有/无外植体清创的网状感染,有外植体的肿瘤复发)和/或有/无疝的结构开裂/网片松动。报告了人口统计学和手术结果。
    结果:246个重建满足纳入(1994-2021)。55例(22.4%)重建术后中位1.08年(IQR0.08,4.53)内发生网状相关事件;那些没有稳定胸部的患者中位为3.9年(IQR,1.59,8.23,p<0.001)。41(16.6%)的网眼被感染,需要再次操作。88%(36/41)被完全外植;8.3%(3/36)需要额外的网格放置。网孔相关事件的预测因素是胸壁放疗之前(OR=9.73,CI3.47至30.10,p<0.001),较高的BMI(OR1.08,CI1.01至1.16,p=0.019),和较大的缺陷(OR1.48,CI1.02至2.17,p=0.042)。既往胸壁放疗患者发生网状相关肥胖事件的风险较高。
    结论:大多数(78%)使用ePTFE网片的患者在中位4年后重建稳定。肥胖,较大的缺陷,和先前的胸壁放疗与网状物相关事件的较高风险相关,主要是由于网状物感染.17%的重建者因网状感染而再次手术;88%被完全移植。只有8%需要更换网格,这表明有经验的外科医生可以安全地管理它们而无需更换。未来的研究应该比较高风险患者的各种网格,以帮助指导最佳网格选择。
    OBJECTIVE: To evaluate the success of expanded polytetrafluoroethylene (ePTFE) mesh in chest-wall reconstruction.
    METHODS: We retrospectively reviewed patients who underwent ePTFE (Gore-Tex®) chest-wall reconstruction. The main outcome was a mesh-related event, defined as a mesh-related reoperation (e.g., mesh infection requiring debridement with/without explant, tumor recurrence with explant) and/or structural dehiscence/mesh loosening with/without a hernia. Demographics and surgical outcomes were reported.
    RESULTS: 246 reconstructions met inclusion (1994-2021). Fifty-five (22.4%) reconstructions had mesh-related events within a median of 1.08 years (IQR 0.08, 4.53) postoperatively; those without had a stable chest for a median of 3.9 years (IQR, 1.59, 8.23, p<0.001). Forty-one (16.6%) of meshes became infected, requiring reoperation. Eighty-eight percent (36/41) were completely explanted; 8.3% (3/36) required additional mesh placement. Predictors of mesh-related events were prior chest-wall radiation (OR=9.73, CI 3.47 to 30.10, p<0.001), higher BMI (OR 1.08, CI 1.01 to 1.16, p=0.019), and larger defects (OR 1.48, CI 1.02 to 2.17, p=0.042). The risk of mesh-related events with obesity was higher with prior chest-wall radiation.
    CONCLUSIONS: Most (78%) patients with an ePTFE mesh had a stable reconstruction after a median of 4 years. Obesity, larger defects, and prior chest-wall radiation were associated with a higher risk of a mesh-related event mostly due to mesh infections. Seventeen percent of reconstructions had reoperation for mesh infection; 88% were completely explanted. Only 8% required replacement mesh, suggesting that experienced surgeons can safely manage them without replacement. Future studies should compare various meshes for high-risk patients to help guide the optimal mesh selection.
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  • 文章类型: Journal Article
    目的:我们的主要目的是综合现有数据,评估不同网状材料在预防性网状物放置中的有效性,并根据造口旁疝(PSH)和其他造口并发症的发生率对这些材料进行排序。
    方法:该网络荟萃分析根据系统评价和荟萃分析声明的首选报告项目进行了系统评价和荟萃分析。在四个数据库中搜索了预防性网状物放置的随机对照试验。汇总结果在贝叶斯分层随机效应模型的STATA例程中进行。
    结果:来自1203篇文章的13项随机对照试验,符合纳入标准,包括681个没有网格的案例,异种脱细胞真皮网状材料65例(猪/牛),27例聚丙烯/PG910,114例聚丙烯/聚glecaprone(Monocryl),117例聚丙烯/纤维素(ORC),233箱聚丙烯,和35例聚丙烯/PVDF。在网络A中,与没有网格相比,只有聚丙烯(RR0.24,95%CI0.04-0.80)与PSH发生率降低显著相关.在网络B中,网状物和无网状物之间在造口并发症方面未发现统计学差异。
    结论:基于网络荟萃分析和排名结果,聚丙烯网眼材料表现出最好的性能。然而,这一结论需要用更大的样本量和高质量的随机对照试验来证实.
    OBJECTIVE: We primary aimed to synthesise the available data, assess the effectiveness of different mesh materials in prophylactic mesh placement, and rank these materials according to the incidence of parastomal hernia (PSH) and other stoma complications.
    METHODS: This network meta-analysis performed a systematic review and meta-analysis according to the Preferred Reporting Items for Systematic Review and Meta-Analysis statement. Four databases were searched for randomised controlled trials of prophylactic mesh placement. The aggregated results were performed in the STATA routine for Bayesian hierarchical random effects models.
    RESULTS: Thirteen randomised controlled trials from 1203 articles, met the inclusion criteria, including 681 cases without meshes, 65 cases with mesh material of xenogeneic acellular dermis (porcine/bovine), 27 cases with polypropylene/PG910, 114 cases with polypropylene/polyglecaprone (Monocryl), 117 cases with polypropylene/cellulose (ORC), 233 cases with polypropylene, and 35 cases with polypropylene/PVDF. In network A, compared with no mesh, only polypropylene (RR 0.24, 95% CI 0.04-0.80) were significantly associated with a reduction in the incidence of PSH. In network B, no statistical difference regarding stoma complications was found between mesh and no mesh.
    CONCLUSIONS: Based on the network meta-analysis and ranking results, the polypropylene mesh material exhibited the best performance. However, this conclusion needs to be confirmed with larger sample sizes and high-quality randomised controlled trials.
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