Tacks Versus Glue for Mesh Fixation in Laparoscopic Ventral Hernia Repair Treating Defects Between 2 and 5 cm Width: a Multicenter Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Duomed
- 入组人数
- 16
- 试验地点
- 11
- 主要终点
- Pain in both groups at 4-6 weeks after LVHR using the Visual Analog Scale (VAS)
研究概览
简要总结
In laparoscopic ventral hernia repair, an abundance of methods has been developed to fix the mesh to the abdominal wall, including sutures (non-absorbable or absorbable), staples (non-absorbable or absorbable), clips, tacks (non-absorbable or absorbable) and (fibrin and synthetic) glues. Which fixation technique is superior, is still under evaluation. There is clearly a need for larger trials to obtain confident results on the safety and performance of glue mesh fixation and tack mesh fixation in LVHR. The hypothesis of this prospective, randomized controlled study is that post-operative pain at 4 to 6 weeks after mesh fixation with glue (LiquiBand® Fix 8™) will not differ compared to treatment with absorbable tacks during LVHR. A total of 510 patients will be recruited for this trial. This study will assess: pain, hernia recurrence, safety, procedural characteristics, technical success, analgesic intake, period to return to normal activity and quality of life.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with ventral hernia (primary or incisional) with a defect size between 2 and 5 cm and eligible for laparoscopic repair.
- •Patients with ASA grade I to III.
- •Patient is at least 18 years old.
- •Patient must sign and date the informed consent form prior to treatment.
排除标准
- •Patient with a recurrence of a previously treated ventral hernia repaired with mesh. Recurrences are only allowed to be included after former primary (suture) repair or retromuscular/onlay mesh repair.
- •Patient is treated by open surgery.
- •Patient has more than one defect. Treatment of Swiss-cheese defects (multiple small defects) is allowed if all defects can be treated with one mesh. Total width cannot exceed 5 cm.
- •Patient with a complex hernia, likely not eligible for laparoscopic repair. Complexity is determined by the investigator (adhesions, small bowel resection, etc).
- •Patient with a life expectancy of less than 2 years.
- •Patient is suspected of being unable to comply with the study protocol.
- •Patient with severe chronic obstructive pulmonary disease.
- •Patient with ASA IV or V.
- •Patient is pregnant.
- •Patient needs acute surgery.
- •Patient is scheduled for surgery within 6 weeks after the index-procedure.
- •Patient has fibromyalgia.
- •Patient with depression as shown in patient medical record.
- •Patient is enrolled in another study.
结局指标
主要结局
Pain in both groups at 4-6 weeks after LVHR using the Visual Analog Scale (VAS)
时间窗: At 4 - 6 weeks
The VAS scale contains a 0 - 100 grading with 0 equaling no pain and 100 equaling the worst conceivable pain. The patient is asked to select the number on the scale that corresponds to the worst level of pain he/she experiences. Pain is classified into mild (1 - 30 mm), moderate (31 - 60 mm) and severe (61 - 100 mm). Absence of pain is defined as VAS = 0.
次要结局
- Quality of life at baseline.(At baseline)
- Quality of life at 12 months follow-up.(At 12 months follow-up)
- Period of hospitalization(up to 5 days)
- Post-operative adverse events(up to 24 months follow-up)
- Pain at discharge using the VAS scale(Up to 5 days)
- Pain at 12 months follow-up using the VAS scale(At 12 months follow-up)
- Quality of life at 4-6 weeks.(At 4 - 6 weeks follow-up)
- Recurrences during follow-up(up to 24 months follow-up)
- Technical success of glue fixation(Intra-operatively)
- Operating time(Intra-operatively)
- Technical success of tack fixation(Intra-operatively)
- Pain at 24 months follow-up using the VAS scale(At 24 months follow-up)
- Intra-operative adverse events(Intra-operatively)
- Usability of the glue during the index-procedure(Intra-operatively)
- Pain at baseline using the VAS scale(At baseline)
- Period to return to normal activity(At 4 - 6 weeks follow-up)
- Quality of life at 24 months follow-up.(At 24 months follow-up)
- Postoperative analgesic intake(Up to 24 months follow-up)