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临床试验/NCT02525666
NCT02525666已完成不适用

Evaluation of Bilateral Laparoscopic Repair of Groin Hernias With One Large Self-fixating Mesh (ProGripTM) in a Prospective Cohort Study

Algemeen Ziekenhuis Maria Middelares1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Assessment of ICIQ-MLUTS Score

研究概览

简要总结

Investigation of a bilateral inguinal hernia repair using one large self-fixating mesh covering both groins. Health outcomes are assessed using different questionaires with focus on urinary symptoms (with ICIQ-MLUTS score), the recurrence rate, postoperative pain measurement, and Quality of Life assessment with EuraHS-QoL and chronic pain monitoring for 12 months.

详细描述

  1. INTRODUCTION

Evidence in groin hernia repair showed a significant reduction in recurrence rates since the introduction of mesh repair. Hence all current guidelines state that in surgical treatment of groin hernias in adults a mesh should be used.

In laparoscopic groin hernia repair a mesh is positioned in the preperitoneal plane. Two techniques are commonly used. A transabdominal technique (TransAbdominal PrePeritoneal - TAPP), in which the preperitoneal plane is dissected throughout the abdomen, with a closure of the peritoneum after positioning of the mesh, and a preperitoneal technique (Totally ExtraPeritoneal - TEP) in which the peritoneum remains intact.

Fixation of the mesh was originally performed by penetrating fixation, using staples or tackers. Alternative fixation with glue, self-fixating meshes or no mesh fixation at all, have been proposed to avoid the postoperative pain related to the penetrating fixation. Several studies were not able to show significant differences in recurrence rates between the different mesh fixation techniques. In general, sufficient overlap seems more important than fixation of the mesh. However, current guidelines state that tacker or suture fixation of the mesh for groin hernia should be avoided.

Concerns are often raised about large medial hernias (EHS classification: M3) because the medial overlap of the mesh beyond the hernia defect is small. An overlap of less than 2-3 cm may lead to protrusion of the mesh in the hernia opening, and this risk is increased in large direct hernias. In general, the larger the hernia opening, the more overlapping there should be. Observational studies have shown a higher recurrence rate in the repair of direct (i.e. medial) hernias. In a recent consensus statement, Poelman et al. stated that diverse types of inguinal hernias (direct vs. indirect, large vs. small) should be distinguished and treated in a different way. Despite the fact that randomized trials did not differentiate between large or small hernias, they state that the use of a heavy weight mesh, mesh fixation or larger mesh size should be considered in case of large medial hernias.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • patients scheduled for primary bilateral inguinal hernia repair

排除标准

  • recurrent groin hernia
  • open hernia repair
  • unilateral hernias
  • concomitant repair of another abdominal hernia e.g. umbilical hernia
  • hernia repair combined with another surgical procedure
  • emergency operations, like incarcerated hernias
  • patients under the age of 18 years or over 80 years
  • ASA score 4 or more
  • patients unable to perform the QoL assessment, because of language barrier or intellectual incapacity
  • no informed consent of the patient

结局指标

主要结局

Assessment of ICIQ-MLUTS Score

时间窗: 12 months

Assessment of urinary symptoms with the ICIQ_MLUTS score at 12 month after laparoscopic repair of bilateral inguinal hernia

次要结局

  • Assessment of ICIQ-MLUTS Score(preoperative, 1 month and 3 month post-operative)
  • Quality of Life assessment(pre-operatively, 1, 3 and 12 month postoperatively)

研究者

发起方
Algemeen Ziekenhuis Maria Middelares
申办方类型
Other
责任方
Principal Investigator
主要研究者

Filip Muysoms

Head of the Department of Surgery

Algemeen Ziekenhuis Maria Middelares

研究点 (1)

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