The aim of this study was to compare postoperative complications and long-term clinical efficacy of electrospun composite biomaterial and porcine small intestine submucosa (SIS) patch in open inguinal herniorrhaphy. A prospective, randomized, single-blind, controlled, multicenter study was used to select 172 patients with inguinal hernia who met the inclusion criteria in 3 hospitals. All participants were randomly assigned (1:1) and treated by open inguinal herniorrhaphy. The experimental group used electrospun composite biomaterial patch and the control group used SIS patch. Complications were assessed by ultrasonic volume auto-scan (UVAS) at 6, 33 and 72 months after operation. The results showed that 53 cases were found to be positive by UVAS, including 20 cases of encapsulated effusion (12.74%), 11 cases of soft tissue edema (6.40%), 4 cases of recurrence (3.01%), 2 cases of testicular ischemic atrophy (1.50%), 7 cases of testicular hydrocele (5.26%), 6 cases of varicocele (4.51%), 2 cases of spermatic cord cyst (1.27%) and 1 case of epididymal head cyst (0.64%). At 33-month follow-up, 2 cases recurred in the control group (2/79, 2.53%) while none in the experimental group (0/78) (the 95% CI difference in effective rates between the two groups was -0.93% to 6.00%, within the preset non-degradation range of Δ10%). At 72-month follow-up, there were 4 cases of recurrence in the control group (4/59, 6.78%), while none in the experimental group (0/60) (the lower limit of 95% CI difference in effective rates between the two groups was 0.27% > 0). The main clinical efficacy of the experimental group was better than that of the control group. There was no statistical difference in the secondary efficacy between the two groups. The postoperative safety evaluation effect of the two groups was the same. Long-term follow-up with UVAS after operation showed that the main clinical efficacy of electrospun composite biomaterial applied in this procedure was superior to that of SIS patch, and there was no significant difference in the secondary efficacy between the two biological patches.
PURPOSE:To explore the risk factors for incisional hernia (IH) recurrence following open prepertioneal repair. METHODS:Patients diagnosed with primary IH who underwent open preperitoneal repair at our hospital were enrolled. Patients were assessed, and perioperative factors were collected. Recurrence surveys were performed at regular intervals throughout the long-term postoperative follow-up. The risk factors for IH recurrence were identified using univariate and multivariate analyses. RESULTS:This study included 145 patients. Significant differences were found between recurrence and non-recurrence patients regarding pulmonary ventilation function (PVT), age, body mass index (BMI), mesh materials, type of surgery (clean, clean-contaminated, or contaminated), surgical site infections (SSIs), maximum width of the hernia defect (MWHD), and site of incisional hernia (P < 0.01). The univariate survival analysis revealed that PVT abnormalities, age > 70 years, BMI > 27 kg/m2, porcine small intestine submucosal (PSIS) mesh, non-clean surgery, SSIs, MWHD > 10 cm, and location in the lateral zones were significant factors for IH recurrence after open preperitoneal repair. The multivariate survival analysis showed that PVT abnormalities, age > 70 years, BMI > 27 kg/m2, and PSIS mesh were independent risk factors for IH recurrence after open preperitoneal repair. CONCLUSIONS:We identified PVT abnormalities, age > 70 years, BMI > 27 kg/m2, and PSIS mesh as novel risk factors for IH recurrence after open preperitoneal repair.
PURPOSE:Incisional hernia is a common postoperative complication; however, few transcriptomic studies have been conducted on it. In this study, we used second-generation high-throughput sequencing to explore the pathogenesis and potential therapeutic targets of incisional hernias. METHODS:Superficial fasciae were collected from 15 patients without hernia and 21 patients with an incisional hernia. High-throughput sequencing of the fascia was performed to generate an expression matrix. We analyzed the matrix to identify differentially expressed genes (DEGs) and performed gene ontology and enrichment analyses of these DEGs. Additionally, an external dataset was utilized to identify key DEGs. RESULTS:We identified 1,823 DEGs closely associated with extracellular matrix (ECM) imbalance, bacterial inflammatory response, and fibrillar collagen trimerization. TNNT3, CMAY5, ATP1B4, ASB5, CILP, SIX4, FBN1 and FNDC5 were identified as key DEGs at the intersection of the two expression matrices. Moreover, non-alcoholic fatty liver disease-related, TNF, and IL-17 signaling pathways were identified as key enrichment pathways. CONCLUSIONS:We identified eight key DEGs and three pathways associated with incisional hernias. Our findings offer new insights into the pathogenesis of incisional hernias and highlight potential targets for their prevention and treatment.
A fabric hydrogel composite hernia mesh with biomechanical and mesh–tissue interface dual compliance is designed for scarless abdominal wall reconstruction. The mesh is composed of a polyester knitted fabric and chitosan–polyacrylamide hydrogel complex. The mechanical properties of the composite mesh are adjusted to resemble the human abdominal wall by alkali treatment of chitosan to achieve good biomechanical compliance. An adhesion group is introduced into the composite mesh that forms covalent bonds with tissue, eliminating the need for suturing, reducing stress concentration at the fixation site, achieving mesh‐tissue interface compliance, and improving the simplicity of the operation. Covalent bonds and hydrogen bonds make the mesh have strong adhesion (70.1 ± 3.2 kPa) and repeatable (four times) robust adhesiveness. In vivo experiments using a rabbit abdominal wall defect model demonstrate quick adhesiveness and excellent functional reconstruction. Biomechanical and mesh–tissue interface dual compliance allow the tissue to regenerate an intact abdominal wall structure. The adhesive fabric hydrogel composite hernia mesh offers significant clinical values for repairing abdominal wall defects and provides design ideas for repairing other load‐bearing soft tissues.
Purpose: Abdominal incisional hernia is one of the most common complications after surgery. The preoperative evaluation of the area of abdominal wall defect and the hernia sac volume(HCV) is very important for the selection of patch size and incisional herniorrhaphy. Meanwhile the overlap range of reinforcement repair is controversial. This study aimed to explore the value of ultrasonic volume autoscan(UVAS) in the diagnosis, classification and treatment of incisional hernia.Methods: Both the width and the area of abdominal wall defect and HCV were measured by UVAS in 50 cases with incisional hernias. In 32 of these cases, the measurements of HCV were compared with those of CT. Classification of incisional hernia based on ultrasonic images were compared with operative diagnosis.Results: The measurements of HCV by UVAS and CT 3D reconstruction had good consistency, of which the mean ratio was 1.0084. According to the location and width of abdominal wall defect, UVAS, which showed good accuracy rate (90%, 96%), reached a good agreement in the classification of incisional hernias with operative diagnoses (Kappa = 0.85, Confidence Interval [0.718,0.996]; Kappa = 0.95, Confidence Interval [0.887,0.999]). The patch area should be at least two times as large as the defect area. Conclusions: UVAS is an accurate alternative to measure the abdominal wall defect and HCV and classify the incisional hernia, with additional benefits of no radiation exposure and instant bedside interpretation. The use of UVAS is conducive to preoperative assessment of the risk of hernia recurrence and abdominal compartment syndrome.(c) 2023 Asian Surgical Association and Taiwan Robotic Surgery Association. Publishing services by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/ licenses/by-nc-nd/4.0/).
The Da Vinci surgical robotic system has revolutionized the field of robotic surgery and has become one of the most ubiquitous and recognized systems in the robotic surgery era. The rapid rise in China’s economy will provide crucial support for the promotion and application of robotic surgical systems in the country’s surgical field. At present, approximately 1.2 million inguinal hernia repairs are performed annually in China. However, many of these surgeries are performed via traditional open repair or laparoscopy methods. Using the purported benefits of robotic surgery system to benefit hernia patients should become a future direction for Chinese hernia surgeons.
Polypropylene (PP) mesh is one of the most widely used artificial meshes to treat hernias. It has many advantages but can also cause chronic inflammation, pain, and adhesion. In inguinal hernia repair, PP mesh may have a negative effect on the reproductive system. In this study, the protective effect of an electrospun fibrous membrane was investigated in an autologous control experiment of inguinal hernia repair in rabbits. Tissue adhesions, obstructions of the spermatic cord, orchiatrophy, and reproductive system abnormalities were highly correlated and mainly appeared soon after implantation. The fibrous membrane, which serves as a biocompatible physical barrier, successfully reduced the deformity and dysfunction of the spermatic cord, testicle, and reproductive system, while polypropylene mesh caused severe damage. In the sub-chronic and chronic stages, at 90 and 180 days, respectively, the peritonealization of the remaining mesh was in the process while the fibrous membrane was degrading. The structure and function of the spermatic cord, testicle, and reproductive system were well protected and maintained because the newly formed tissue prevented contact between the mesh and the spermatic cord. Thus, introducing a fibrous membrane in inguinal hernia repair reduces the adverse effects of polypropylene mesh.(c) 2023 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
目的 探讨复合生物补片在腹股沟疝修补术中的远期临床价值.方法 采用前瞻性随机对照非劣效性研究方法.选取2014年7月至2015年2月复旦大学附属华东医院等3家医学中心收治的172例成人腹股沟疝患者的临床资料,按照随机数字表法将患者分为两组.患者均行腹股沟后壁加强+补片重建修补术,术中使用静电纺复合生物补片设为试验组,使用进口猪小肠黏膜下层补片设为对照组.观察指标:(1)入组患者分组情况.(2)研究终点.正态分布的计量资料以(x)±s表示,组间比较采用独立样本t检验.计数资料以绝对数或百分比表示,组间比较采用x2检验或Fisher确切概率法.等级资料比较采用非参数秩和检验.以术后6年疝复发率作为有效性评价依据,使用Cochran-Mantel-Haenszel检验进行组间比较.非劣效性检验采用间隔法进行,若两组疝复发率差值的95%可信区间下限>-10%,则认为试验组非劣于对照组;若下限>0,则认为试验组优于对照组.结果 (1)入组患者分组情况.筛选出符合研究条件的成人腹股沟疝患者172例;均为男性;年龄为(61±2)岁.172例患者随机分配至试验组和对照组各86例.随访6年,试验组和对照组分别有20例和19例患者失访.(2)研究终点.①主要研究终点:术后6年,试验组66例患者无复发,对照组67例患者中4例疝复发.非劣效检验结果显示:两组患者疝复发率差值的95%可信区间为0.27%~14.41%,下限0.27%>-10%,且同时>0.②次要研究终点:试验组和对照组术后6个月、术后6年静息或咳嗽状态简单疼痛评分量表评分比较,差异均无统计学意义(P>0.05).术后6个月随访,试验组和对照组患者中分别有2例和5例发生并发症,两组比较,差异无统计学意义(x2=1.38,P>0.05).术后6年随访,两组患者均未发生并发症.结论 复合生物补片应用于腹股沟疝修补术安全、可行,远期疝复发率低,临床疗效良好.
Objectives:To investigate the clinical value of a novel non-crosslinked biological mesh in laparoscopic inguinal hernia repair.Methods:The prospective randomized controlled study was conducted. The clinical data of 50 adult patients with unilateral inguinal hernia who were admitted to 3 medical centers, including Ruijin Hospital of Shanghai Jiaotong University School of Medicine et al, from September 2019 to March 2020 were selected. Based on random number table, patients were divided into two groups. Patients using the novel non-crosslinked biological mesh in repair surgery were divided into the experiment group and patients using the lightweight, micro-porous, partially absorbable synthetic mesh in repair surgery were divided into the control group. Observation indicators: (1) grouping situations of the enrolled patients; (2) endpoint of the study. 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 as M(range), and comparison between groups was conducted using the non-parameter rank sum test. Count data were described as absolute numbers and (or) persentages, and comparison between groups was conducted using the chi-square test or Fisher exact probability. Comparison of ordinal data was conducted using the non-parameter rank sum test. Repeated measurement data were analyzed using the repeated ANOVA. Taking the recurrence rate of hernia as the basis of efficacy evaluation, according to the intention-to-treat analysis, the confidence interval method (Newcombe Wilson method) was used to conduct non-inferiority statistical analysis of the recurrence rate of hernia between the experiment group and the control group. If the upper limit of 95% confidence interval of the difference of recurrence rate of hernia between the experiment group and the control group is less than 10%, the experiment group is considered to be non-inferior to the control group. Results:(1) Grouping situations of the enrolled patients. A total of 50 adult patients with inguinal hernia were selected for eligibility. There were 44 males and 6 females, aged (60±15)years. All 50 patients were randomly divided into to the experiment group and the control group with 25 cases each. One patient in the control group was not followed up at postoperative month 2, and the rest of 49 patients completed all expected follow-up. No patient in the two groups fell off or were removed. (2) Endpoint of the study. ① The primary endpoint of study. The recurrence rate of hernia was 0 in the experiment group, versus 4%(1/25) in the control group, respectively, showing no significant difference between the two groups ( P>0.05). Results of non-inferiority statistical analysis showed that the 95% confidence interval of the difference of recurrence rate of hernia between the two groups was -19.54% to 9.72%, with the upper limit as 9.72%, which was less than 10%. ② The secondary endpoint of study. There were 2 patients in the control group occurred seroma at postoperative day 14, and none of the rest of patient in the two groups occurred seroma during the follow-up, showing no significant difference in the occurrence of seroma between the two groups ( P>0.05). There was 1 patient in the control group feeling discomfort or foreign body sensation in groin area at postoperative month 2, and none of the rest of patient in the two groups feeling discomfort or foreign body sensation in groin area during the follow-up, showing no significant difference in the feeling discomfort or foreign body sensation in groin area between the two groups ( P>0.05). There was no patient occurred surgical site infection in the experiment group, and there was 1 patient in the control group occurred postoperative skin infection, which had no relationship with mesh. There was no patient in both two groups occurred fever, anaphylaxis and patch related serious adverse reaction during the follow-up. The resting visual analogue scale score, active visual analogue scale score of patients at postoperative 2 days and postoperative 18 months were 0.44±1.00, 1.28±1.46 and 0, 0 in the experiment group, versus 0.40±0.76, 1.28±1.14 and 0.24±1.20, 0.44±1.29 in the control group, respectively. There was a significant difference in the time effect of postoperative active visual analogue scale score of patients between the two groups ( Ftime=10.19, P<0.05). The thickness of the novel non-crosslinked biological mesh before implantation was 0.5?0.7 mm. Two months after operation, results of B-ultrasonic examination in groin area of 10 patients from the experiment group showed a strong echo area at the patch implant area with a thickness as 2 mm. Conclusion:Application of novel non-crosslinked biological mesh in laparoscopic inguinal hernia repair is safe and effective.
Polypropylene (PP) mesh has been one of the most frequently selected materials for abdominal wall hernia (AWH) repair in the past decades. However, the repair effectiveness is often compromised by the high incidence of adverse events. Improvements are highly desirable to reduce unwanted visceral adhesion and increase tissue integration. Herein, we developed a PP-based composite mesh combined with alginate-assistant nanofiber membrane (NFM) by assembling a large-pore lightweight PP mesh, a NFM barrier consisting of poly (lactic-coglycolic acid) (PLGA) and polycaprolactone (PCL), and an alginate hydrogel (AH). In vitro studies revealed that the resulting meshes had excellent structural stability, mechanical properties, and biocompatibility. The NFM barriers were firmly attached to the PP substrates, with AH effectively eliminating the delamination without unwanted damage to the nanofiber barrier. In vivo experiments showed that incorporating AH-assistant NFM into PP prostheses could prevent visceral adhesion in an effective manner and promote mesh integration into surrounding tissues from the abdominal wall. These results prove a novel facile and successful strategy to endow prosthetic meshes with superior anti-adhesion capability and tissue compatibility for repairing AWH.
针对疝修补合成补片植入后带来的多种并发症问题,明确了并发症的诱发因素为病原菌带来的污染和补片本体材料导致的异物反应.以临床常用的经编补片为研究对象,将目前应对疝修补术后并发症的手段分为经编结构调控和表面修饰改性.根据应对场景(有菌性炎症和无菌性炎症)和使用场合(腹腔内和腹腔外)的不同,对表面修饰改性进行了分类阐述.列举了近年来相关研究及临床商用补片取得的成果进展,并将表面改性补片归纳为抗菌型、防粘连型、抗炎型,通过分别概述其相应的作用机制及并发症应对效果,分析了当前3种不同类型表面改性补片存在的问题,并指出具有高附加功能的经编补片将是未来的发展方向.
目的 分析造口旁疝不同修补术式的有效性和安全性.方法 回顾性分析2006年1月至2021年1月复旦大学附属华东医院普外科收治的403例造口旁疝病人的临床资料及随访结果,对不同手术方式的临床结局进行分析.结果 所有入组病人均接受手术治疗,年龄(67.1±4.7)岁,BMI为27.5±3.1.手术时间57~620(127.1±30.2)min,术后住院时间为4~61(6.2±2.3)d.术后近期并发症包括手术部位感染(SSI)42例,血清肿或血肿19例,不全性肠梗阻19例,造口并发症7例,肠管损伤2例.另有死亡2例,皆因高龄嵌顿疝急诊手术后出现多器官功能衰竭而死亡.中位随访时间36个月,复发55例(13.6%),造口相关并发症14例,不全性肠梗阻22例,迟发性补片感染7例,慢性疼痛11例.不同术式比较,复发率从高到低依次为:缝合修补(29.4%)、Keyhole手术(15.3%)、Sugarbaker手术(3.2%),Sandwich手术和造口移位无复发;Sugarbaker手术后肠梗阻发生率最高(19.4%).不同手术入路比较,开放手术后SSI(18.1%)和肠梗阻(6.4%)发生率均为最高,杂交手术病人造口相关并发症发生率最高(7.5%).结论 治疗造口旁疝的不同手术方法中,Keyhole手术在补片修补手术中复发率最高,Sugarbaker和Sandwich手术复发率相对较低,但须注意预防术后肠梗阻的发生.造口旁疝总体疗效仍有待提高,术式及材料仍需不断发展,腹腔镜修补手术疗效与传统开放手术相近,将占据更重要的治疗地位.
Complex systems science (CSS) is an evaluation system that integrates the overall system and draws multilateral conclusions in the form of dynamic and reasonable interpreta-tion. Evaluation of modern hernia and abdominal wall surgery by CSS includes the application of artificial intelligence, data analysis and other methods. It implements the value oriented clinical quality improvement principle in the overall treatment cycle through the measurement of value, combined cost, quality evaluation and patient perspective. Finally, CSS will realize the sustainable development of hernia and abdominal wall surgical diagnosis and treatment system of medical care system.
血清肿作为腹股沟疝修补术后常见的并发症,由于不同学者对于血清肿理解认知不同,导致报道的腹股沟疝修补术后血清肿发生率差异较大.患者因素、医师的经验以及补片材质、固定方式等均是患者术后形成血清肿的重要原因;在治疗方面,大多数情况下血清肿可无需临床干预即可自行吸收,仅当患者出现严重症状、感染等少数情况下进行临床干预.因此,对于降低围手术期血清肿的发生率仍需以预防为主.笔者就腹股沟疝术后血清肿的研究文献作一综述,以期为临床提供参考.
目的 比较腹腔镜下应用生物材料补片和合成材料补片对老年腹股沟疝修补术后患者血清肿发生率的影响.方法 采用前瞻性对照临床研究方法,纳入华东医院普外科2021年6月—2021年12月收治的单侧老年腹股沟疝患者30例,采用数字表法随机分为生物材料组(n=15)和合成材料组(n=15).所有患者均由同一组医师进行经腹腔腹膜前修补术(TAPP),术后1个月、3个月、6个月随访进行体格检查及彩色多普勒超声检查.观察并比较2组术后彩超下血清肿情况、其他并发症和随访情况.结果 术后1个月彩超诊断生物材料组血清肿发生率高于合成材料组(66.7%vs 13.3%,P<0.05);术后3个月生物材料组彩超诊断血清肿发生率高于合成材料组,但差异无统计学意义(6.67%vs 0%,P>0.05);术后6个月2组均未发现血清肿.生物材料组术后平均体温明显高于合成材料组(37.2℃vs 36.7℃,P<0.05);2组术后静息、咳嗽疼痛评分差异均无统计学意义(P>0.05);2组随访期间均未出现复发和感染等其他并发症.结论 TAPP术后第1个月生物材料的血清肿发生率高于合成材料,术后随访需要密切关注.
手术技术的发展,临床证据的累积以及循证医学证据的丰富对于腹壁切口疝的手术发展有着重要的指导意义.早在2001年和2003年中华医学会外科学分会疝和腹壁外科学组就制定了《腹壁切口疝诊疗方案(草案)》[1-2],经过了 10年的经验积累于2012年、2014年及2018年3次制定和修订了中国《腹壁切口疝诊疗指南》[3],为我国切口疝的治疗提供了理论基础和依据.
The number of hernia surgery is huge, but the surgical effects are totally different. The cooperation between clinical nurses and doctors in the perioperative period of hernia surgery and nursing in enhanced recovery after surgery are very important. According to the different characteristics of inguinal hernia, abdominal incisional hernia and parastomal hernia, different medical and nursing joint modes are needed for cooperation and clinical intervention, especially in the prevention and treatment of venous thromboembolism. Real-time monitoring and guidance shall be given, so as to promote patients and medical staff to actively participate in the formulation and implementation of clinical diagnosis and treatment plan, to help surgical patients achieve enhanced recovery after surgery.
Electrospun nanofibrous membranes (NFM) can serve as a physical barrier, employed to confer polypropylene (PP) mesh with anti-adhesion capability for repairing abdominal wall hernias. Still, the feasibility of NFM combined with different PP meshes was poorly researched. In this study, nanofiber containing composite meshes with three PP substrates were produced by integrating the NFM barrier compositing poly (lactic-co-glycolic acid) and polycaprolactone (PLGA/PCL) into each PP mesh. Tensile mechanical test results revealed that the PP component played a dominant role in the mechanical support, and this structure has not deteriorated in any case during the process. In vitro cell studies showed that the PP mesh with a higher density was significantly beneficial for cell proliferation within 3 days of seeding, while the one with lower density exhibited notable cell proliferation after a culture of 5 days. All the meshes had excellent biocompatibility. Moreover, an intraperitoneal implantation rabbit model was used to assess the anti-adhesion effects and tissue compatibility. The results revealed that the NFM barrier could be incorporated into the lightweight PP mesh to yield the composite mesh with superior anti-adhesion property and tissue compatibility.
疝和腹壁外科是近20年来发展较快的外科分支之一.疝病是基本外科的常见疾病.手术技术及修复材料的进展,大大推动了该专业的发展.20世纪90年代初,黎介寿等率先向国内介绍了疝和腹壁外科的新进展,即无张力疝修复技术[1-2].1997年,马颂章将网塞-平片技术(Robbins-Rutkow技术)引进中国,无张力疝修补术在我国广泛开展.我国疝和腹壁外科进入快速发展时期.