未经评估:本研究评估了OviTex®1S的性能(TELABioInc.,马尔文,PA,美国)用于腹侧疝修补术超过24个月。
未经批准:这是一个潜在的,单臂,多中心临床试验(ClinicalTrials.gov/NCT03074474)。纳入了92例腹疝患者队列。手术方法(开放,腹腔镜,或机器人)和放置平面(直肌,腹膜内,或腹膜前)由外科医生自行决定。基于以下合并症,患者被表征为手术部位发生(SSO)的高风险:BMI在30和40之间,活跃的吸烟者,慢性阻塞性肺疾病(COPD),糖尿病,冠状动脉疾病,高龄(≥75岁)。受试者接受体检以评估安全事件,并在1个月时完成生活质量调查,3个月,12个月,手术后24个月.
UNASSIGNED:92名患者中有65名(70.7%)完成了24个月的随访。在730天(24个月)的复发风险的KaplanMeier估计为2.6%;在完成24个月访问或先前复发的受试者中,未调整复发率为4.5%(3/66).在38.0%的患者中观察到SSO(35/92)。最普遍的SSO是发生在20.7%(19/92)的患者中的手术部位感染,其次是血清肿的形成,发生在13.0%的患者中;然而,只有3.3%需要干预。HerQLes和EQ-5D评估显示在手术后3个月从基线改善。持续改善持续24个月。
UNASSIGNED:总体上,BRAVO研究表明,使用绵羊增强的组织基质OviTex1S是用于腹侧疝修复的可行选择。需要进行更长期随访数据的其他研究,以得出有关使用OviTex1S的明确结论。
UNASSIGNED: This
study evaluated the performance of OviTex® 1S (TELA Bio Inc., Malvern, PA, USA) over 24 months when used for ventral hernia repair.
UNASSIGNED: This was a prospective, single-arm, multi-center clinical
trial (ClinicalTrials.gov/NCT03074474). A ninety-two patient cohort with ventral hernias were enrolled. The surgical approach (open, laparoscopic, or robotic) and plane of placement (retrorectus, intraperitoneal, or pre-peritoneal) were at the discretion of the surgeon. Patients were characterized as high risk for a surgical site occurrence (SSO) based on the following comorbidities: BMI between 30 and 40, active smoker, chronic obstructive pulmonary disease (COPD), diabetes mellitus, coronary artery disease, advanced age ( ≥ 75 years). Subjects underwent physical examinations to evaluate safety events and completed quality of life surveys at 1 months, 3 months, 12 months, and 24 months post-surgery.
UNASSIGNED: Sixty-five of the 92 enrolled patients (70.7%) completed 24-month follow-up. The Kaplan Meier estimate for risk of recurrence at day 730 (24 months) was 2.6%; among subjects who completed their 24-month visit or had a previous recurrence, the unadjusted rate of recurrence was 4.5% (3/66). SSOs were observed in 38.0% of patients (35/92). The most prevalent SSO was surgical site infection occurring in 20.7% (19/92) of patients, followed by seroma formation, which occurred in 13.0% of patients; however, only 3.3% required intervention. HerQLes and EQ-5D assessments showed improvement from baseline as soon as 3 months post-surgery. Continued improvement was observed through 24 months.
UNASSIGNED: Overall the BRAVO
study demonstrates that use of the ovine reinforced tissue matrix OviTex 1S is a viable option for use in ventral hernia repair. Additional studies with longer term follow-up data are needed to draw definitive conclusions on the use of OviTex 1S.