Validation of Quality of Life Assessment After Laparoscopic TAPP and TEP Surgery of Inguinal Hernias Using EuraHS of Life Score and Carolinas Comfort Scale™
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 3
- 主要终点
- assessment of the EuraHS-QoL
研究概览
简要总结
A multicenter observational study trial validating Quality of Life assessment using EuraHS Quality of Life score and Carolinas Comfort scale™ in patients before and after laparoscopic unilateral inguinal hernia repair.
Depending on the treating physician patients will receive a TAPP or TEP repair for their inguinal hernia and a self-gripping mesh will be used for the repair (Parietex Progrip Mesh).
Primary endpoint will be assessment by the EuraHS-QoL at 1 year after laparoscopic repair of an unilateral inguinal hernia using the Anatomic ProGrip™ Laparoscopic self-fixating mesh.
Secondary endpoints are assessment of the QoL 3 preoperative, 3 weeks and 1 year postoperative, recurrence rate at 12 months, intra-operative and post-operative complications, post-operative hospital stay, operation time and time to place the mesh, VAS (Visual Analog Scale) for pain at several control points, VRS (Verbal Rating Score) for pain at 3 weeks and 12 months, pain medication needed.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent from the patient or his/her legal representative
- •Primary unilateral inguinal hernia undergoing a preperitoneal laparoscopic repair.
排除标准
- •No written informed consent
- •Recurrent groin hernia
- •Open hernia repair
- •Bilateral hernias
- •Concomitant repair of another abdominal hernia eg umbilical hernia
- •Hernia repair combined with another surgical procedure
- •Emergency operations, like incarcerated hernias
- •Patients under the age of 18 years and over 80 years
- •Pregnant women
- •ASA score 4 or more
- •Patients unable to perform the QoL assessment, because of language barrier or intellectual incapacity
结局指标
主要结局
assessment of the EuraHS-QoL
时间窗: 1 year after start study
questionnaire assessment
次要结局
- change in EuraHS-QoL assessment(preoperatively (at inclusion), 3 weeks and 1 year, postoperatively recurrence rate at 12months)