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临床试验/NCT07351760
NCT07351760已完成不适用

Outpatient Department Repair of Small Primary Ventral Hernias

Karolinska Institutet1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2023年12月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
37
试验地点
1
主要终点
Complications

研究概览

简要总结

Ventral hernias are among the most common conditions requiring surgical intervention. Due to their benign nature, elective repairs of primary ventral hernias are usually given low priority for planned surgery. Routines for hernia repair that do not require operating theatre resources are therefore needed.

Repair under local anaesthesia has been demonstrated to be a safe and effective approach. While inguinal hernia repair under local anaesthesia is well established and extensively studied, primary ventral hernia repair under local anaesthesia has received comparatively limited attention. Although previous studies have demonstrated the safety of primary ventral hernias repair under local anaesthesia, most procedures are still performed in conventional operating theatres. The present prospective pilot study was therefore designed to assess the safety, feasibility, and patient satisfaction of repairing small, uncomplicated primary ventral hernias under local anaesthesia in the outpatient department using suture repair, without the resources available in the operating theatre.

The study is conducted as a single-arm pilot study. Adult patients of both sexes diagnosed with a small primary ventral hernia were assessed for eligibility. The primary outcome is the safety and feasibility of performing PVH repair under local anesthesia in the outpatient department, including patient tolerance and perioperative safety. Secondary outcomes included patient satisfaction, postoperative pain, and short-term recurrence.

Outpatient Department Repair is performed in a designated outpatient procedure room, separate from the conventional operating theatre. Local anesthesia is administered in a stepwise manner. Initially, local anesthesia is injected intradermally at the incision site. After confirming adequate anesthetic effect, a skin incision is made, and the subcutaneous tissue is dissected until the hernia sac is identified. Additional local anesthesia is applied directly into the wound at this stage.

For umbilical or paraumbilical hernias, the umbilicus is carefully separated from the hernia sac and surrounding fascia. During this phase, patients are asked standardized intraoperative questions while the surgeon continues the procedure. The hernia sac is reduced, and a further infiltration of local anesthesia is administered into the fascia adjacent to the defect.

The fascial defect is closed with a single horizontal running suture line using a continuous 2-0 polypropylene suture. When applicable, the umbilicus is reattached to the fascia using a 4-0 polydioxanone suture, positioned approximately 1 cm above or below the fascial suture line, to reduce the risk of suture sinus or chronic pain. The subcutaneous tissue is sutured with 3-0 polyglactin, and the skin is closed intracutaneously using 4-0 Monocryl.

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

  • Age 18-80 years
  • Body mass index (BMI) ≤ 30 kg/m²
  • Primary ventral hernia with fascia defect size < 2 cm

排除标准

  • Inability or unwillingness to provide informed consent
  • Contraindications to local anaesthesia
  • Pregnancy
  • BMI > 30 kg/m²
  • Ongoing anticoagulant therapy

研究组 & 干预措施

Outpatient department repair

Experimental

Outpatient department repair of selected small primary ventral hernias under local anesthesia

干预措施: Outpatient department repair (Procedure)

结局指标

主要结局

Complications

时间窗: 30 days

Complications related to the procedure, including surgical site infections, hematoma and severe intraoperative pain

次要结局

  • Pain(Within two hours after surgery)
  • Hernia recurrence(Six months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gabriel Sandblom

Associate Professor

Karolinska Institutet

研究点 (1)

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