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临床试验/NCT02770703
NCT02770703
终止
不适用

Mesh Position and Outcomes Following Open (Lichtenstein), Endoscopic (TEP) and Laparoscopic (TAPP) Inguinal Hernia Repair Using a MRI Visible Hernia Mesh

University Hospital, Basel, Switzerland1 个研究点 分布在 1 个国家目标入组 60 人2016年4月

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Unilateral Simple Inguinal Hernia
发起方
University Hospital, Basel, Switzerland
入组人数
60
试验地点
1
主要终点
Evaluation of Mesh Position per MRI
状态
终止
最后更新
4年前

概览

简要总结

Inguinal hernia repair can be considered as one of the most frequent surgeries in general surgery worldwide. Surgical hernia repair procedures can generally be divided into minimally invasive (TEP, TAPP) and open techniques (e.g. Lichtenstein) and are equivalent with some advantages and disadvantages. The posterior wall of the inguinal channel is usually reinforced by a synthetic mesh, while non-mesh based surgeries have been steadily abandoned.

Two of the most frequent complications following hernia surgery are hernia recurrence and chronic groin pain. Latter can occur in up to 10%. Both represent a considerable socio-economic impact. While different surgical hernia procedures and mesh fixation techniques have been evaluated as influential factors, the impact of mesh position and mesh deformation on hernia recurrence and chronic groin pain is unknown. This may be even more important, since endoscopic and laparoscopic hernia surgery procedures (TEP, TAPP) carry the risk of suboptimal mesh positioning, due to the final steps at the end of the surgery, where the mesh position is not under direct visual control.

Until now direct mesh visualization was impossible. A recent development of MRI visible meshes (DynaMesh® visible) provides the opportunity to evaluate mesh position and deformation after hernia surgery. In case of suspicious clinical hernia recurrence or postoperative chronic groin pain the mesh position can now directly be identified with Magnetic Resonance (MR) imaging preventing unnecessary explorative surgery.

In this study the investigators plan to perform MRI scans to assess mesh position and deformation 90 days postoperatively and correlate it with the clinical status and pain score (VAS) of the patient. In order to allow for an optimal comparison of the post-operative mesh position in relation to the operative technique, patients will be randomized to minimally invasive (TEP, TAPP) and open techniques (e.g. Lichtenstein). To the investigators knowledge this is the first study investigating the impact of the three most common surgical hernia procedures on postoperative mesh position and deformation and its correlation to the clinical findings focussing on hernia recurrence and chronic groin pain.

注册库
clinicaltrials.gov
开始日期
2016年4月
结束日期
2019年3月
最后更新
4年前
研究类型
Interventional
研究设计
Parallel
性别
Male

研究者

发起方
University Hospital, Basel, Switzerland
责任方
Sponsor

入排标准

入选标准

  • Male patients with a primary symptomatic unilateral inguinal hernia.
  • Patients eligible to undergo hernia repair either by minimally invasive (TEP, TAPP) or open techniques (e.g. Lichtenstein) as judged by the treating surgeon
  • Written informed consent

排除标准

  • Previous inguinal hernia repair
  • Bilateral inguinal hernia
  • Femoral hernia repair
  • Repair in local anesthetics,
  • Previous abdominal surgery
  • Emergency surgery, e.g. incarcerated hernias
  • Contraindication for MRI scans (e.g. Pacemakers and similar implants, cochlea implants, claustrophobia)
  • Contraindications to usage of mesh e.g. known hypersensitivity or allergy
  • Women who are pregnant or breast feeding
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia

结局指标

主要结局

Evaluation of Mesh Position per MRI

时间窗: 90 days postoperatively

次要结局

  • Groin pain using visual analogue scale(0, 1, 90, 365 days postoperatively)
  • Evaluation of Mesh Deformation per MRI(90 days postoperatively)
  • Recurrence of hernia(0, 1, 90, 365 days postoperatively)

研究点 (1)

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