A Clinical Study of Postoperative Pain Following Laparoscopic Transabdominal Preperitoneal Inguinal Hernioplasty. Comparing Parietex ProGrib With Tacks for Mesh Fixation
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Number of patients with recurrent hernia.
研究概览
简要总结
A clinical study evaluating acute and chronic pain following laparoscopic inguinal hernia repair comparing the ProGripTM self- fixating mesh with tack fixation.
详细描述
The primary aim of this study is to evaluate acute and chronic pain following laparoscopic inguinal hernia repair comparing the ProGripTM self- fixating mesh with tack fixation. The ProGripTM laparoscopic self-fixating mesh has been approved for implantation to reinforce the abdominal wall during laparoscopic inguinal hernia repair (TAPP). The mesh delivers tack free fixation above and below the inguinal ligament potentially eliminating pain associated with traditional tack fixation. The present study is a prospective randomized clinical trial designed to collect information about complications such as acute and chronic pain and hernia recurrence rate from patients referred for laparoscopic inguinal hernia repair. Patients who qualify to take part in the study will be randomized for a procedure using either a self-gripping ProGrip mesh or a conventional polypropylene mesh attached with AbsorbaTackTM. Data will be collected from operations performed at 6 high volume hernia centers in Denmark.
Patients eligible for study will be recruited from the referral list for inguinal hernia repair at each participating institution. Prior to scheduled surgery, patients will be consented and will complete a questionnaire on inguinal pain intensity and quality of life .
The mesh will be placed intraperitoneally after the component separation is complete. The peritoneal layer will be closed with a V-loc stitch in both groups.
After surgery, key clinical data will be recorded, such as type of mesh used, size of the hernia defect, number of tacks used etc.
The participating patients will receive postoperative questionnaires following the first year after surgery.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for elective, inguinal hernia repair
- •18 years or older
- •Male gender
- •ASA physical classification system 1-3
- •Informed consent
排除标准
- •Patients with recurrent hernia, except patients operated in childhood without mesh application.
- •Patients with bilateral hernia
- •Patients with chronic pain
- •Patients in anticoagulation therapy
- •Previous major surgery in lower abdomen
结局指标
主要结局
Number of patients with recurrent hernia.
时间窗: 1 year
Number of patients experiencing acute postoperative pain, using the NRS pain score.
时间窗: 3 months
次要结局
- Number of patients experiencing chronic postoperative pain, using the NRS pain score.(1 year)
- Quality of life before and after surgery, using the Carolina Comfort Scale(6 months)