跳至主要内容
临床试验/NCT07514273
NCT07514273已完成不适用

Outpatient Repair of Small Reducible Ventral Hernias Using Local Anesthesia: A Pilot Study

Region Örebro County1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2024年1月1日最近更新:
适应症
干预措施

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

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

Experimental

singel arm

干预措施: Repair of small ventral hernia under lokal anesthesia (Procedure)

Pliot study, singel arm

Experimental

singel arm

干预措施: Hernia Repair (Procedure)

Pliot study, singel arm

Experimental

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

研究者

发起方
Region Örebro County
申办方类型
Other
责任方
Sponsor

研究点 (1)

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