NCT05306496进行中（未招募）不适用
Laparoscopic Inguinal and Femoral heRniA rePaIr Using Pre-shapeD 4DMESH® (4DLap): Assessing Hernia Recurrence and Pain up to 5-years Follow-up
Cousin Biotech14 个研究点 分布在 3 个国家目标入组 196 人开始时间: 2022年6月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 196
- 试验地点
- 14
- 主要终点
- Hernia recurrence
研究概览
简要总结
The purpose of this study is to evaluate the safety and performance of the 4DMESH® used in (robot-assisted) laparoscopic inguinal and femoral hernia repair. The goal of the study will be achieved by assessing the prevalence of recurrences, pain, quality-of-life (QoL), return to daily activities and work and groin symptoms, and by reporting of peri- and postoperative complications in a prospectively maintained database.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has a primary unilateral or primary bilateral inguinal or femoral hernia eligible for (robot-assisted) laparoscopic TEP or TAPP repair.
- •Patients with American Society of Anesthesiologists (ASA) grade I to III.
- •Patient ≥ 18 years of age at study entry.
- •Patient and investigator signed and dated the informed consent form prior to the index-procedure.
排除标准
- •Patient has a recurrent inguinal or femoral hernia.
- •Patient is treated using the Lichtenstein technique.
- •Patients with ASA grade IV and V.
- •Patient is allergic to the components of the 4DMESH®.
- •Presence of an infected site.
- •Patient has a life expectancy of less than 5 years.
- •Patient is unable / unwilling to provide informed consent.
- •Patient is unable to comply with the protocol or proposed follow-up visits.
- •Patient is enrolled in another study (BE/ES) / Participation in a clinical trial within 3 months prior to the initial visit (FR).
- •Patient is pregnant (BE/FR) / Pregnant women (ES).
- •Patient benefiting from a legal protection measure (minors, under guardianship, curatorship, safeguard of justice, future protection mandate or family empowerment) (FR).
- •Patient not benefiting from a social protection scheme (FR).
结局指标
主要结局
Hernia recurrence
时间窗: At 12-months follow-up
To determine the prevalence of hernia recurrence at 12-months follow-up via an abdominal ultrasound during an in-hospital visit.
次要结局
- Technical success(At index-procedure)
- Return to daily activities(At 4-5 weeks follow-up)
- Duration of hospital stay(At the moment the patient is discharged from the hospital after the procedure (discharge), an average of 1 day)
- Duration of surgery(At index-procedure)
- Mesh migration and mesh shrinkage(At 12-months follow-up)
- Return to work(At 4-5 weeks follow-up)
- EQ-5D change(At 60-months follow-up)
- Peri- and post-operative complications related to 4DMESH®(At 5-years follow-up)
- Early recurrences(At 4-5 weeks follow-up)
- Late recurrence rate(At 60-months follow-up)
- Re-intervention(At 5-years follow-up)
- Explantation rate(At 5-years follow-up)
- Intake of analgesics(At 60-months follow-up)
- QoL(At 60-months follow-up)
- Global groin symptoms(At 60-months follow-up)
- Post-operative pain scoring(At 60-months follow-up)
- Pre-operative pain scoring(At baseline)
- Subjective groin symptoms(At 60-months follow-up)
- Impact on sex life(At 60-months follow-up)
- Late recurrence rate(At 24-months follow-up)
- Post-operative pain scoring(At discharge, an average of 1 day)
- Post-operative pain scoring(At 4-5 weeks follow-up)
- Post-operative pain scoring(At 12-months follow-up)
- Post-operative pain scoring(At 24-months follow-up)
- Intake of analgesics(At the moment the patient is discharged from the hospital after the procedure (discharge), an average of 1 day)
- Intake of analgesics(At 4-5 weeks follow-up)
- Intake of analgesics(At 12-months follow-up)
- Intake of analgesics(At 24-months follow-up)
- QoL(At baseline)
- QoL(At 4-5 weeks follow-up)
- QoL(At 12-months follow-up)
- QoL(At 24-months follow-up)
- EQ-5D change(At 4-5 weeks follow-up)
- EQ-5D change(At 12-months follow-up)
- EQ-5D change(At 24-months follow-up)
- Subjective groin symptoms(At 4-5 weeks follow-up)
- Subjective groin symptoms(At 12-months follow-up)
- Subjective groin symptoms(At 24-months follow-up)
- Global groin symptoms(At 4-5 weeks follow-up)
- Global groin symptoms(At 12-months follow-up)
- Global groin symptoms(At 24-months follow-up)
- Impact on sex life(At 4-5 weeks follow-up)
- Impact on sex life(At 12-months follow-up)
- Impact on sex life(At 24-months follow-up)
研究者
研究点 (14)
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