Evaluating the use of absorbable sutures versus sTaples versus tIssue glue in laparoscopic port skin closure (STILS) trial: A prospective, multi-centre randomised clinical trial (RCT).

IF 2.3 4区 医学 Q2 SURGERY
Sinead E Ramjit, Matthew G Davey, Stephen Keelan, Emer Herlihy, Marie Dromey, Chris Garvey, Timothy S Nugent, Aisling Fawaz, Lauren O'Connell, Melanie Cunningham, Matthew Fahy, Eanna J Ryan, Brendan Moran, Lylas Aljohmani, Jeyanthi Narayanasamy, Michael E Kelly, Clara Healy, Claire Donohoe, Narayansamy Ravi, Paul Neary, John V Reynolds, Noel E Donlon
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引用次数: 0

Abstract

Methods: This prospective, multi-centre RCT was conducted in accordance with the CONSORT guidelines for prospective, parallel group randomised studies. Adult patients undergoing elective laparoscopic surgery at two teaching hospitals in Dublin, Ireland were recruited and assigned to one of three closure methods (sutures (SU), staples (ST) or tissue glue (TG)) with primary outcome being cosmesis and secondary outcomes being closure speed, wound complications, cost effectiveness and sustainability outcomes being assessed by a blinded outcomes assessor.

Results: A total of 147 patients were recruited and randomised with a total of 138 being examined in the final analysis (SU = 48, ST = 63, TG = 27). Patient demographics were similar across all groups for gender, mean age, body mass index and American Society of Anaesthesiologists grade (all p > 0.050). For cosmesis, SU had the lowest overall mean observer (p < 0.001) and patient (p = 0.005) scar scores. Furthermore, when evaluating the breakdown for Observer Scar Score (OSS), SU had the lowest vascularity (p = 0.001), pigmentation (p = 0.006), thickness (p < 0.001), relief (p = 0.003) and pliability (p < 0.001). For patient scar score (PSS), SU had the lowest irregularity (p = 0.035). SU was the most cost-effective (p < 0.001) and had the lowest total produced non-recyclable waste (p < 0.001). ST had the shortest closure time (p < 0.001). Overall, there was a no difference in wound complication rates (SU = 6.3 %, ST = 6.4 %, TG = 18.5 %; p = 0.130).

Conclusion: In conclusion, SU was the most effective method for laparoscopic port site closure with regards to cosmesis, cost-efficiency and surgical sustainability. ST was the marginally quicker method of closure and demonstrated equipoise in terms of complication rate. We advocate for SU as the current 'gold standard' with reduced non-recyclable waste generated and a valuable training opportunity for junior trainees.

Trial registration: ClinicalTrials.gov Identifier: NCT03843866.

评估可吸收缝线、订书钉和组织胶在腹腔镜气道皮肤闭合(STILS)试验中的使用:一项前瞻性、多中心随机临床试验(RCT)。
方法:这项前瞻性、多中心随机对照试验按照CONSORT前瞻性、平行组随机研究指南进行。在爱尔兰都柏林的两家教学医院接受选择性腹腔镜手术的成年患者被招募,并被分配到三种缝合方法(缝合线(SU),订书针(ST)或组织胶(TG))中的一种,主要结果是美容,次要结果是缝合速度,伤口并发症,成本效益和可持续性结果,由盲法结果评估者评估。结果:共招募147例患者并随机分组,最终分析共检查138例(SU = 48, ST = 63, TG = 27)。在性别、平均年龄、体重指数和美国麻醉师协会评分方面,所有组的患者人口统计数据相似(p < 0.05)。结论:总之,在美容、成本效益和手术可持续性方面,SU是腹腔镜下端口闭合最有效的方法。ST是稍快的缝合方法,在并发症发生率方面表现出平衡。我们提倡将可持续发展作为当前的“黄金标准”,减少不可回收废物的产生,并为初级学员提供宝贵的培训机会。试验注册:ClinicalTrials.gov标识符:NCT03843866。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
4.40
自引率
0.00%
发文量
158
审稿时长
6-12 weeks
期刊介绍: Since its establishment in 2003, The Surgeon has established itself as one of the leading multidisciplinary surgical titles, both in print and online. The Surgeon is published for the worldwide surgical and dental communities. The goal of the Journal is to achieve wider national and international recognition, through a commitment to excellence in original research. In addition, both Colleges see the Journal as an important educational service, and consequently there is a particular focus on post-graduate development. Much of our educational role will continue to be achieved through publishing expanded review articles by leaders in their field. Articles in related areas to surgery and dentistry, such as healthcare management and education, are also welcomed. We aim to educate, entertain, give insight into new surgical techniques and technology, and provide a forum for debate and discussion.
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