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Prophylactic sublay non-absorbable mesh positioning following midline laparotomy in a clean-contaminated field: randomized clinical trial (PROMETHEUS).
British Journal of Surgery ( IF 9.6 ) Pub Date : 2021-04-28 , DOI: 10.1093/bjs/znab068
F Pizza 1 , D D'Antonio 1 , A Ronchi 2 , F S Lucido 3 , L Brusciano 3 , A Marvaso 1 , C Dell'Isola 4 , C Gambardella 3
Affiliation  

BACKGROUND Incisional hernia is a frequent postoperative complication after midline laparotomy. Prophylactic mesh augmentation in abdominal wall closure after elective surgery is recommended, but its role in emergency surgery is less well defined. METHODS This prospective randomized trial evaluated the incidence of incisional hernia in patients undergoing urgent midline laparotomy for clean-contaminated surgery. Closure using a slowly absorbable running suture was compared with closure using an additional sublay mesh (Parietex ProGrip™). Patients were randomized just before abdominal wall closure using computer-generated permuted blocks. Patients, care providers, staff collecting data, and those assessing the endpoints were all blinded to the group allocation. Patients were followed up for 24 months by means of clinical and ultrasonographic evaluations. RESULTS From January 2015 to June 2018, 200 patients were randomized: 100 to primary closure (control group) and 100 to Parietex ProGrip™ mesh-supported closure (mesh group). Eight patients in the control group and six in the mesh group were lost to follow-up. By 24 months after surgery, 21 patients in the control group and six in the mesh group had developed incisional hernia (P = 0.002). There was no difference between groups in the incidence of haematoma (2 versus 5; P = 0.248) and superficial wound infection (4 versus 5; P = 0.733). Multivariable analysis confirmed the role of mesh in preventing incisional hernia (odds ratio 0.11, 95 per cent c.i. 0.03 to 0.37; P  < 0.001). One patient in the mesh group required mesh removal because of deep infection. CONCLUSION Prophylactic mesh-augmented abdominal wall closure after urgent laparotomy in clean-contaminated wounds is safe and effective in reducing the incidence of incisional hernia. Registration number: NCT04436887 (http://www.clinicaltrials.gov). GRAPHICAL ABSTRACT An RCT was conducted to compare the widely recommended midline laparotomy closure using a slowly absorbable running suture with closure using a sublay mesh (Parietex ProGrip™), in patients undergoing urgent midline laparotomy for clean-contaminated surgery. Patients were followed up for 24 months with clinical and ultrasonographic evaluation during outpatient visits. Prophylactic reinforcement of the midline abdominal wall, using a ProGrip™ Parietex mesh in the retromuscular position, at the time of urgent laparotomy in clean-contaminated wounds was safe and effective in reducing the incidence of incisional hernia, although larger studies with longer follow-up are required.

中文翻译:

中线剖腹手术后在干净污染的领域中预防性垫层不可吸收的网状定位:随机临床试验(PROMETHEUS)。

背景技术切口疝是中线剖腹手术后的常见术后并发症。推荐在择期手术后腹腔壁封闭术中进行预防性网状扩张,但其在急诊手术中的作用尚不明确。方法这项前瞻性随机试验评估了接受紧急中线剖腹手术进行清洁污染手术的患者切开疝的发生率。将使用可缓慢吸收的缝合线进行的闭合与使用其他衬网(Parietex ProGrip™)进行的闭合进行比较。使用计算机生成的排列块,在腹壁闭合前将患者随机分组。患者,护理提供者,收集数据的工作人员以及评估终点的人员都对小组分配不知情。通过临床和超声检查对患者进行了24个月的随访。结果从2015年1月至2018年6月,将200例患者随机分组:100例为原发闭合(对照组),100例为Parietex ProGrip™网状支持闭合(网状组)。对照组中有8例患者,网状组中有6例患者失访。到手术后24个月,对照组21例,网状组6例发生切口疝(P = 0.002)。两组之间的血肿发生率(2对5; P = 0.248)和浅表伤口感染(4对5; P = 0.733)没有差异。多变量分析证实了网状网在预防切口疝中的作用(比值0.11,95%ci为0.03至0.37; P <0.001)。网状组中的一名患者由于深层感染而需要移除网状结构。结论在清洁污染的伤口中进行紧急剖腹手术后,预防性网状增强腹壁闭合术是安全有效的,可减少切开疝的发生。注册号:NCT04436887(http://www.clinicaltrials.gov)。在接受紧急中线剖腹术进行清洁污染手术的患者中,进行了一项RCT,以比较广泛推荐的采用缓慢吸收的缝合线进行中线剖腹术封闭与使用子网格(Parietex ProGrip™)进行封闭的比较。在门诊就诊时对患者进行了24个月的随访,并进行了临床和超声检查。在后肌位置使用ProGrip™Parietex网格预防性加固中线腹壁,
更新日期:2021-04-28
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