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临床试验/NCT03935490
NCT03935490已完成不适用

The Transrectus Sheath Pre-peritoneal (TREPP) Technique for Strangulated Inguinal Hernia: a Case-series

University Medical Center Groningen1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2019年5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
45
试验地点
1
主要终点
Recurrence rate

研究概览

简要总结

n the Sint Jansdal Hospital in Harderwijk, the Netherlands, the TREPP technique is the standard operating procedure for patients with inguinal hernia. Starting from 2006, this procedure has also been used on patients that presented with an acute strangulated inguinal hernia in the emergency department, instead of the more common Lichtenstein technique. The goal of this retrospective case series is to assess the feasibility of the TREPP technique in case of an acute strangulated inguinal hernia. Patient records from 2006 until 2016 will be used to search for patients treated for acute inguinal hernia in that period. After applying the in- and exclusion criteria, patients who are eligible for inclusion will be contacted by telephone. They will be asked if they are willing to visit the surgical outpatient department once and fill out two questionnaires. The data of these questionnaires will be analyzed and published.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Emergency surgery for suspected strangulated inguinal hernia (within 6 hours after admission)
  • e-TREPP performed

排除标准

  • No emergency surgery (for instance, surgery day after admission or later).
  • No e-TREPP performed

结局指标

主要结局

Recurrence rate

时间窗: From surgery date up to 12 years postoperatively

Patient electronic records will be searched for re-operations for recurrent inguinal hernia. Also, patients will be asked in the outpatient department if they received recurrence surgery or suffer new complaints.

Chronic postoperative inguinal pain according to Visual Analog Scale

时间窗: From surgery date up to 12 years postoperatively

Patients will be asked to fill out the VAS on a horizontal line of 10 millimeters long. Patients will be asked to mark the point that indicated the amount of pain they experience. The distance from the left marker will be measured, with increasing distance at greater pain intensity.

次要结局

  • Short-term complications(Complications occuring from the start of the operation up to 30 days postoperative)
  • Sexual complaints related to e-TREPP(Between >30 days postoperatively and through study completion, average 6 years)

研究者

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

Thomas Zwols

Principal Investigator

University Medical Center Groningen

研究点 (1)

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