A Controlled Randomized Study of Protack, Securestrap and Glubran Glue as Fixation Devices in Laparoscopic Ventral Herniotomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Pain
研究概览
简要总结
Clinical, controlled, randomized, prospective study. Ventral hernias between 2(1.5)cm and 7 cm, laparoscopic surgery with intraperitoneal onlay mesh.
Three randomization groups of 25 patients giving a total of 75 patients. Mesh is fixated with either Protack, Securestrap or Glubran II. Primary outcome: postoperative pain on the 2nd postoperative day. Secondary outcomes: pain, quality of life, recurrence and adhesions at 1, 6, 12, 24, 36, 48 and 60 months postoperative.
详细描述
see brief summary
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ventral hernia 2(1,5) < dia > 7 cm
- •danish speaking
- •of sound mind
- •bmi < 35
- •ASA 3 or less, no contra indication against laparoscopy
排除标准
- •other size hernias,
- •no danish,
- •bmi > 35
研究组 & 干预措施
fixation with Glubran
surgery
干预措施: laparoscopic ventral herniotomy (Procedure)
fixation with Glubran
surgery
干预措施: Glubran (Device)
fixation with Protack
干预措施: laparoscopic ventral herniotomy (Procedure)
fixation with Protack
干预措施: Protack (Device)
fixation with Securestrap
干预措施: laparoscopic ventral herniotomy (Procedure)
fixation with Securestrap
干预措施: Securestrap (Device)
结局指标
主要结局
Pain
时间窗: 1 measurement, 2nd postoperative day
Dolo Test (VAS)
次要结局
- hernia recurrence(7 measurements, postoperative month 1, 6, 12, 24, 36, 48 and 60)
- quality of life(7 measurements, postoperative month 1, 6, 12, 24, 36, 48 and 60)
- Pain(7 measurements, day 1, 3 and 4 and postoperative month 1, 6, 12, 24)
研究者
Hans Friis-Andersen
Principal Investigator
Horsens Hospital