COMPARISON OF TWO DIFFERENT CONCEPTS OF MESH AND FIXATION TECHNIQUE IN THE LAPAROSCOPIC OPERATIONS FOR VENTRAL AND INCISIONAL HERNIA - A RANDOMIZED CONTROLLED MONOCENTER TRIAL.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Pain
研究概览
简要总结
This is a monocenter randomized controlled trial comparing two systems of mesh and fixation device for the laparoscopic ventral and incisional hernia repair with respect to pain. It has been designed as a superiority study to proof the concept of previously published mathematical model of front abdominal wall.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed Consent Form (ICF) signed by the patient or his/her legal representative
- •primary or secondary ventral hernia less than 20 cm in length and less than 11 cm in width requiring elective surgical repair
- •recurrence after former abdominal hernia repair WITH MESH
- •recurrence after suture abdominal hernia repair CAN be included
排除标准
- •no written informed consent
- •patient under 18 years old
- •emergency surgery (incarcerated hernia)
- •patients with expected life time shorter than one year for example due to generalised malignancy
- •BMI exceeding 40.0kg/m²
- •contaminated surgical fields
- •patients on immunosuppression, steroid therapy, constant pain therapy
研究组 & 干预措施
PH
Intraperitoneal onlay mesh (IPOM) repair with the use of Phisiomesh implant and Securestrap fixation device.
干预措施: ETHICON PHYSIOMESH® (Device)
PH
Intraperitoneal onlay mesh (IPOM) repair with the use of Phisiomesh implant and Securestrap fixation device.
干预措施: Intraperitoneal onlay mesh (IPOM) repair with the use of Phisiomesh implant and Securestrap fixation device. (Procedure)
VS
Intraperitoneal onlay mesh (IPOM) repair with the use of Ventralight ST implant with SorbaFix fixation device.
干预措施: Intraperitoneal onlay mesh (IPOM) repair with the use of Ventralight ST implant with SorbaFix fixation device. (Procedure)
VS
Intraperitoneal onlay mesh (IPOM) repair with the use of Ventralight ST implant with SorbaFix fixation device.
干预措施: Ventralight ST implant (Device)
结局指标
主要结局
Pain
时间窗: 3 months after the surgery
Presence of pain 3 months after the surgery.
次要结局
- Number of Participants with Recurrences(up to one year)
- Number of Participants with complications.(up to one year)
- Pain intensity(6 months after the surgery)
研究者
Maciej Pawlak
MD
Polish Hernia Study Group