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临床试验/NCT06979687
NCT06979687已完成不适用

Knotless Barbed Suture Closure of the Uterus at Caesarean Section

South Tees Hospitals NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 957 人开始时间: 2022年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
957
试验地点
1
主要终点
Post-operative infection

研究概览

简要总结

Caesarean section (CS) is an increasingly common mode of delivery. The way in which this operation is carried out is important as it affects millions of women each. In recent years use of a 'self-retaining' suture or thread for closure of the uterine closure has become a recognised approach with a proven safety record. These sutures are known as knotless barbed sutures (KBS) as the unidirectional barbs on the surface of the suture hold the suture in the tissue without the need for knots. These sutures can be used instead of the usual 'smooth' suture which requires knots at the angles. There are high-level level data that CS are quicker and on average need fewer additional stitches to control blood loss when KBS are used. There is additional evidence of a potential reduction in problems with healing of the uterus with KBS, it is thought that this might lead to a lower risk of problems in repeat CS as the chance of the placenta implanting into the scar might be lower. At present this evidence is based on ultrasound surveillance of scar appearance which is an indirect measure. The real risk difference will need to be explored with the examination of real world outcomes over the coming years.

There is currently no published data on KBS for uterine closure at caesarean from the UK. This cohort, although retrospective, is adequately controlled, shows excellent outcomes and signals a potential marked reduction in infectious morbidity. This potentially means a better patient experience as well as a large cost saving because of reduced re-admission rates. These data were collected as part of a service improvement project but the generalisable nature of our findings mean the finding are research and should be published.

详细描述

Caesarean section (CS) is one of the most commonly performed operations worldwide and the prevalence is increasing1. There are perioperative complications including neonatal morbidity and, on the maternal side, haemorrhage, infection and organ injury2. Furthermore, there are implications for future pregnancies, the risks of which rise with each successive caesarean3. Closure of the lower segment hysterotomy at CS is most commonly affected using a 2-layer approach employing braided absorbable sutures such as Vicryl (polyglactin 910)4. Closure is with a continuous suturing technique and the tension of the closure is maintained manually until the suture is secured with knots at the angles. Knotless barbed suture (KBS) closure of the caesarean hysterotomy remains a novel technique that is not yet widely employed. These sutures, first invented in 1964, were approved by the FDA in 2004 and were first used in a clinical trial in 20075. Barbed sutures anchor themselves within the tissue, as barbs on the suture resist backward movement through the tissue. They offer even tension over the length of the hysterotomy and are cut flush with the uterus without the need for anchoring knots.

A systematic review and meta-analysis of randomised control trials (n460) on KBS compared with 'smooth' sutures at elective CS found that operative times were lower and the need for additional haemostatic sutures was lower6. There was a trend towards lower blood loss and no difference in operative morbidity. Some trials, some of which are ongoing, have examined whether there is a difference in lower segment residual myometrial thickness (RMT) after KBS and whether there is a difference in the incidence of scar niche7. These outcomes, respectively, are offered as potential proxy measures for uterine rupture risk and praevia or PAS risk. The results of these trials, as per their proxy outcomes, have been encouraging. This trial offers the first data on KBS at CS in UK practise.

Methods:

This single-centre retrospective cohort study in a tertiary care hospital in Northern England including caesarean deliveries from November 2022 to October 2024 - a 24 month period. The cohorts are women who had a Medtronic's V-loc 180 absorbable device (KBS) and women who had 2 layer vicryl (polyglactin 910) uterine closure i.e. smooth suture (SS).

Data was collected prospectively using a Microsoft Excel™ spreadsheet by the lead clinician (HS) as part of a quality improvement project and data was cross-referenced with patient records using Clevermed badgernotes ™ maternity system data records. Baseline characteristics reported are: patient age at delivery, parity, number of previous caesarean sections, BMI at booking, additional intraoperative interventions, birth-weight, indication for, and category of, caesarean, mode of anaesthesia, grade of operator and whether a consultant was present if not the primary surgeon (Table 1). The pre-specified outcome was blood loss. The pre-specified secondary outcomes were operating time, infection rates, readmission, unplanned outpatient attendance, and other complications.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • Women undergoing a caesarean section at the study hospital within the data collection period for that cohort - either with or without KBS depending on the cohort.

排除标准

  • Not falling within the search criteria for a comparator group

结局指标

主要结局

Post-operative infection

时间窗: up to 6 weeks post-operative

Whether antibiotics were prescribed for a surgical site infective complication.

次要结局

  • operating time(Intraoperative)
  • Blood loss(In theatre during the operation)
  • Readmission(up to 6 weeks post-operative)
  • Re-attendance as an outpatient(up to 6 weeks post-operative)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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