Safety and Efficacy of the Optomesh® 3D Implant (TZMO S.A., Poland) in Laparoscopic-Endoscopic Inguinal Hernia Repair - A Multicenter, Prospective Observational Study (OPTIMUS Study)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Inguinal Hernia Recurrence Within 12 Months
研究概览
简要总结
OPTIMUS is an observational study assessing the safety and effectiveness of Optomesh 3D, a shaped surgical mesh used in planned keyhole surgery for a groin (inguinal) hernia. The mesh is placed without additional stitches, tacks, or glue to hold it in position.
The study aims to include at least 300 patients from several hospitals. The main question is how often a hernia returns within 12 months after surgery. Researchers will also assess pain, postoperative complications, discomfort in the groin, and the feeling of having a foreign material in the operated area.
Participants will provide written consent for the study. Information about their health and operation will be recorded. Follow-up information will be collected through telephone interviews at 7-10 days, 30 days, 3 months, and 12 months after surgery. The results will be assessed in relation to previously published findings on hernia repair.
详细描述
OPTIMUS is a prospective, multicenter, observational cohort study evaluating the safety and clinical performance of the Optomesh® 3D implant (TZMO S.A., Poland) in elective laparoendoscopic inguinal hernia repair. The study focuses on outcomes after transabdominal preperitoneal (TAPP) or totally extraperitoneal (TEP) repair with mesh placement without additional fixation. Each participant will be followed for 12 months after surgery.
Optomesh® 3D is an anatomically shaped, non-absorbable polypropylene mesh intended for inguinal hernia repair. It is manufactured from transparent and blue monofilament polypropylene yarn and includes an orientation marker. Right-sided and left-sided variants are available in S/M and L sizes. The implant variant and size are selected according to the patient's anatomy.
Consecutive patients of both sexes undergoing elective repair with this implant will be considered for enrollment at participating surgical centers. Participation requires written informed consent and fulfillment of the study eligibility criteria. Collected data will include patient characteristics, body mass index, comorbidities, surgical approach, operative time, and implant size. Operative documentation will include video recordings or photographs of surgical steps. These materials will be coded and made available to investigators through a restricted-access platform. Study data will be stored in a secured database.
Follow-up assessments will take place at 7-10 days, 30 days, 3 months and 12 months after surgery. Telephone questionnaires will collect information on recurrence, pain, complications, groin discomfort, and foreign body sensation. Pain intensity will be assessed using a 0-10 visual analog scale. Chronic pain will be evaluated as pain persisting beyond 3 months, interfering with daily activities, and exceeding 4/10 on the pain scale. Early complications will be assessed within 30 days, with further complication assessment throughout the 12-month follow-up.
The primary outcome is inguinal hernia recurrence within 12 months after surgery. The primary analysis will estimate the 12-month recurrence rate, together with a 95% confidence interval. Outcomes will be interpreted in relation to historical benchmarks specified in the study protocol and statistical analysis plan. Additional analyses will describe changes in pain and other patient-reported symptoms over time and explore associations between outcomes and patient characteristics, surgical approach, and implant size.
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.
- •Male or female patients scheduled for elective repair of a primary inguinal hernia.
- •Eligibility for laparoendoscopic repair using the transabdominal preperitoneal (TAPP) or totally extraperitoneal (TEP) approach.
- •Planned use of Optomesh 3D without additional mesh fixation as part of routine clinical care.
- •Written informed consent to participate in the study.
排除标准
- •Age below 18 years.
- •Emergency surgery, including emergency repair of an incarcerated inguinal hernia.
- •Contaminated surgical field.
- •Recurrent inguinal hernia.
- •Extremely large scrotal hernias requiring additional measures to prevent abdominal compartment syndrome, such as botulinum toxin administration, progressive preoperative pneumoperitoneum, or bowel resection for volume reduction.
- •M3 or combined M3+L1-L3 inguinal hernia according to the European Hernia Society (EHS) classification, confirmed intraoperatively.
研究组 & 干预措施
Optomesh 3D Cohort
Consecutive patients undergoing elective laparoendoscopic inguinal hernia repair using Optomesh 3D without additional mesh fixation at participating centers. Surgery is performed using either the transabdominal preperitoneal (TAPP) or totally extraperitoneal (TEP) approach as part of routine clinical care. Participants are followed prospectively for 12 months after surgery to assess hernia recurrence, postoperative pain, complications, groin discomfort, and foreign body sensation.
干预措施: Optomesh 3D (Device)
结局指标
主要结局
Inguinal Hernia Recurrence Within 12 Months
时间窗: From surgery through 12 months after surgery.
Percentage of participants reporting recurrence of an inguinal hernia at the operated site within 12 months after the index operation. Information on recurrence is collected through scheduled follow-up telephone interviews.
次要结局
- Postoperative Groin Pain Intensity(7-10 days, 30 days, 3 months and 12 months after surgery.)
- Chronic Postoperative Inguinal Pain(3 months and 12 months after surgery.)
- Early Postoperative Complications(From surgery through postoperative day 30.)
- Late Postoperative Complications(Postoperative day 31 through 12 months after surgery.)
- Groin Discomfort(7-10 days, 30 days, 6 months, and 12 months after surgery.)
研究者
Mateusz Zamkowski
MD, PhD, FEBS AWS
Swissmed Hospital