Outpatient Repair of Small Reducible Ventral Hernias Using Local Anesthesia: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Safety and feasibility of repair under local anesthetics only
研究概览
简要总结
Primary midline hernias, including umbilical and epigastric hernias, are prevalent surgical conditions, necessitating intervention. The optimal choice of anesthesia for umbilical and epigastric hernia repair remains an area of uncertainty. This pilot study focuses on the management of primary midline hernias, specifically umbilical and epigastric hernias, with an emphasis on anesthesia choice and repair techniques. Debates persist regarding the timing of elective repairs for primary ventral hernias. The study is prompted by the hypothesis that local anesthesia may offer superior outcomes, particularly for frail patients. While both mesh-reinforced and suture repairs are utilized, evidence supporting the superiority of mesh for small-sized hernias is limited.
A systematic review from 2017 supports the safety and feasibility of local anesthesia for umbilical hernia repair. A retrospective study indicates favorable outcomes, reduced operating time, and increased patient satisfaction with day case procedures under local anesthesia. This study aims to assess the safety and feasibility of repairing small reducible hernias using local anesthesia in the outpatient department. The investigation seeks to provide insights into the potential advantages of local anesthesia over general anesthesia in the repair of small reducible hernias. This summary succinctly outlines the key objectives, hypotheses, and methodologies of the pilot study within the specified word limit.
详细描述
Primary midline hernias, including umbilical and epigastric hernias, are prevalent surgical conditions, necessitating intervention. Differing opinions exist among surgeons regarding the timing of elective repair for primary ventral hernias, with some advocating for immediate intervention, while others prefer a watchful waiting approach. The optimal choice of anesthesia for umbilical hernia repair remains an area of uncertainty. A systematic review published in 2017 concluded that local anesthesia for umbilical hernia repair was safe and feasible. A retrospective study, including 476 patients divided into four different types of hernias (epigastric, umbilical, small incisional, and Spigelian hernia), showed that when performed under local anesthesia as a day case procedure, it is a safe technique associated with favorable long-term outcomes. A recently published study found that the repair of ventral hernia with local anesthesia is safe, reduces operating time, and results in higher patient satisfaction.
We hypothesized that employing local anesthesia, as opposed to general anesthesia, would yield superior outcomes, particularly for frail patients. While both mesh-reinforced and suture repairs are utilized for treating primary hernias, there is limited evidence supporting the superiority of mesh repair for small-sized hernias (diameter <2 cm). A meta-analysis suggests a marginally lower recurrence rate in patients undergoing mesh repair compared to those receiving prolene-suture repair without mesh for small hernias. However, the use of mesh may introduce persistent pain or other mesh-related complications. Patients with small hernias are typically managed in the operating theater under general anesthesia, a resource-intensive and time-consuming approach associated with potential complications. Conversely, performing the procedure under local anesthesia not only enhances patient safety but also conserves resources. Previous studies have indicated that repairing ventral hernias under local anesthesia may reduce operative time and associated complications. In this pilot study, the investigators aim to assess the safety and feasibility of performing repairs for small reducible hernias using local anesthesia in the outpatient department.
Ventral hernias, particularly those located in the midline such as umbilical and epigastric hernias, represent common surgical conditions. Management strategies for these hernias vary, with debates surrounding the timing of elective repair. This pilot study aims to investigate the potential advantages of utilizing local anesthesia over general anesthesia in the repair of small reducible hernias, primarily focusing on patient safety and resource conservation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hernia defect size ≤ 2 cm Primary hernia BMI ≤ 30 Age 18-80 years
排除标准
- •Hernia defect size > 2 cm BMI > 30 Recurrent hernia Pregnancy
研究组 & 干预措施
Pliot study, singel arm
singel arm
干预措施: Repair of small ventral hernia under lokal anesthesia (Procedure)
Pliot study, singel arm
singel arm
干预措施: Hernia Repair (Procedure)
Pliot study, singel arm
singel arm
干预措施: OPD Repair (Procedure)
结局指标
主要结局
Safety and feasibility of repair under local anesthetics only
时间窗: From enrollment to the end of treatment up to 12 months
Zero is equivalent to no pain and 10 indicates the worst possible pain
Safety and feasibility of the procendure
时间窗: From enrollment to the end of the treatment 12 months
The first five repairs will be performed in the operating theatre with anesthesiology back-up in order to evaluate feasibility and safety. The subsequent repairs will be performed in the outpatient department under local anesthesia only.
Number of Participants with Treatment-Related Adverse Events as Assessed by clinical follow up.
时间窗: From enrollment to the end of treatment at 12 weeks
Zero is equivalent to no pain and 10 indicates the worst possible pain.
次要结局
未报告次要终点
