ProGrip Mesh Repair Versus Lichtenstein Mesh Repair: a Comparative Randomized Study in Primary Inguinal Hernia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 603
- 试验地点
- 18
- 主要终点
- Pain Assessment During the First Three Months and at One Year After Surgery Using a Surgical Pain Scales (SPS)
研究概览
简要总结
The objective of the study is to evaluate pain and disabling complications inducing social consequences in primary inguinal hernia ProGrip mesh repair compared to Lichtenstein repair with lightweight polypropylene mesh.
详细描述
- Patients in ProGrip group will be treated with self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation.
- Patients in Lichtenstein group will be treated with lightweight Polypropylene meshes requiring fixation by sutures.
- Study participation will start at signature of informed consent and each patient will be assessed before surgery. A close follow-up will be performed: 7 days (questionnaires and phone call), 1 month (clinical visit), 3 months (questionnaires and phone call), and final evaluation at 12 months (clinical visit) after surgery, which will end the participation to the study.
- 600 adult males divided in 2 groups requiring primary uncomplicated elective inguinal hernia mesh repair will be included in the study. Patients will be stratified by center.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 31 Years 至 74 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •All male patients at participating centers with a primary, uncomplicated inguinal hernia.
- •Collar of the defect ≤ 4 cm
- •Signed informed consent
排除标准
- •30 years ≥ Age ≥ 75 years
- •Emergency procedure
- •Inclusion in other trials
- •Bilateral inguinal hernia
- •Recurrence
结局指标
主要结局
Pain Assessment During the First Three Months and at One Year After Surgery Using a Surgical Pain Scales (SPS)
时间窗: M3, M12 after surgery
Surgical pain scales (=SPS) completed by patient during consultation or will be sent to the patient with instructions to complete it and send it back by mailing. The score of evaluation will be reported in mm, specifying if pain occurs at rest, during normal activities, during exercise. The score is ranged from 0 (no pain) to 150 mm (the worst pain yu have never known).
Pain Assessment During the First Three Months and at One Year After Surgery Using a Visual Analogue Scale (VAS)
时间窗: M3, M12 after surgery
Pain assessment during patient follow up after surgery using VAS score. VAS going from 0 mm (no pain) to 150 mm (worst conceivable pain) is presented to the patient who draw a vertical line on the scale to indicate the average amount of pain at the time of consultation or at home.
次要结局
- Other Post-operative Complications(M12 after surgery)
- Return to Work and to Normal Daily Activities(Effective date)
- Wound Complications and Hernia Recurrences(M12 after surgery)
- Foreign Body Sensation(M1, M3, M12 months after surgery)
- Chronic Pain Defined as Pain Lasting More Than 3 Months Using VAS Score(3 months after surgery)