Safety and Efficacy of the 3DMax MID Anatomical Mesh (BD, USA) in Laparoendoscopic Inguinal Hernia Repair: A Multicenter Prospective Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 主要终点
- Inguinal hernia recurrence rate at 12 months
研究概览
简要总结
This is a multicenter, prospective, observational cohort study evaluating the safety and efficacy of the 3DMax MID Anatomical Mesh (BD, USA) in laparoendoscopic inguinal hernia repair. Adult patients undergoing elective transabdominal preperitoneal (TAPP) or totally extraperitoneal (TEP) repair will be enrolled and followed according to routine clinical practice.
The primary objective is to assess the inguinal hernia recurrence rate within 12 months after surgery. Secondary objectives include evaluation of postoperative pain, groin discomfort and foreign body sensation, as well as early and late postoperative complications.
All participating patients will receive the 3DMax MID Anatomical Mesh as part of standard care. No additional experimental procedures are planned. Clinical data will be collected at baseline and during predefined follow-up contacts (early postoperative period, 1 month, 3 months and 12 months) using standardized forms and patient interviews.
详细描述
Laparoendoscopic techniques such as transabdominal preperitoneal (TAPP) and totally extraperitoneal (TEP) repair are widely used for the treatment of inguinal hernia and are associated with faster recovery and lower rates of chronic pain compared with open repair in appropriately selected patients. Mesh reinforcement is a key component of these procedures. Three-dimensional, anatomically contoured meshes have been developed to improve conformability to the myopectineal orifice and to provide stable coverage of the inguinal region, potentially reducing the need for additional fixation and lowering the risk of chronic postoperative pain.
The 3DMax MID Anatomical Mesh (BD, USA) is a medium-weight, macroporous, pre-shaped polypropylene mesh designed specifically for inguinal hernia repair. Its three-dimensional configuration and recoil properties are intended to facilitate correct positioning and stable coverage of the inguinal anatomy during laparoendoscopic procedures.
This multicenter, prospective, observational cohort study will include consecutive adult patients undergoing elective TAPP or TEP inguinal hernia repair in participating centers, in whom the operating surgeon has decided to use the 3DMax MID Anatomical Mesh as part of routine practice. No randomization or control group is planned, and no interventions outside standard care will be performed.
Data will be collected from medical records and structured follow-up contacts (early postoperative check, approximately 30 days, 3 months and 12 months after surgery). The primary endpoint is hernia recurrence within 12 months. Secondary endpoints include postoperative pain, groin discomfort, foreign body sensation and early or late postoperative complications. Study data will be recorded in a standardized database and analyzed descriptively to characterize the safety profile and clinical performance of the 3DMax MID Anatomical Mesh in real-world practice.
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
- •Age 18 years or older
- •Primary unilateral or bilateral inguinal hernia
- •Scheduled for elective laparoendoscopic inguinal hernia repair (TAPP or TEP)
- •Considered suitable for general anesthesia and laparoendoscopic approach by the treating surgeon
- •3DMax MID Anatomical Mesh planned for use as part of routine clinical care
- •Ability and willingness to provide written informed consent
排除标准
- •Age below 18 years
- •Emergency surgery (e.g. incarcerated or strangulated hernia requiring urgent intervention)
- •Contaminated or potentially contaminated surgical field
- •Recurrent inguinal hernia in the same groin (previous repair with mesh or suture)
- •Concomitant procedures or clinical situations in which the surgeon decides that a different mesh concept or technique is required
- •Inability or unwillingness to comply with follow-up schedule (e.g. lack of telephone contact, severe cognitive impairment)
结局指标
主要结局
Inguinal hernia recurrence rate at 12 months
时间窗: 12 months after index surgery
Proportion of patients with clinically and/or imaging-confirmed inguinal hernia recurrence within 12 months after the index laparoendoscopic repair with 3DMax MID Anatomical Mesh.
次要结局
- Postoperative pain intensity (VAS 0-10)(7-10 days, 30 days, 3 months and 12 months after surgery)
- Early postoperative complications (≤30 days)(Up to 30 days after surgery)
- Late postoperative complications (>30 days to 12 months)(From >30 days to 12 months after surgery)
- Groin discomfort and foreign body sensation(7-10 days, 30 days, 3 months and 12 months after surgery)