Randomized Prospective Single-Blinded Study of Totally Extra Peritoneal Inguinal Hernia Repair: Tacking Mesh Versus Self-fixating Mesh
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Number of Participants With Early Postoperative Complications
研究概览
简要总结
Investigators are testing whether tacking mesh or self-fixating mesh used for inguinal hernia repair makes any difference in short-term pain or return to normal activities following the operation. Other studies have shown no significant difference in hernia recurrence rate when metal tacks are not used to hold the mesh in place.
详细描述
Participants will be placed into two groups. One group of participants will have mesh tacked into place for their hernia repairs. The other group will have self-fixating mesh into place. Both groups will have a piece of mesh that will widely cover the hernia defect. Before surgery, the participant will be asked to rate discomfort on a 0-10 scale. Zero stands for no pain and 10 is the worst pain they can imagine. Investigators will record information about general medical condition, medications and activity level. During the operation information will be recorded about the pain medicines the participant may receive. In the recovery room the participant will be asked to rate their pain on the 0-10 scale and more information will be recorded about any additional pain medicines that they may receive and assess activity level. Following surgery, Investigators will contact the participants by survey to obtain more information about pain level, medication use, and activity level.
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 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •All patients regardless of sex or age who were diagnosed with a inguinal hernia and underwent a totally extraperitoneal (TEP) inguinal hernia repair at the Mayo Clinic in Rochester, Minnesota from June 2013 - June 2014.
排除标准
- •Patients who did not elect to undergo a hernia repair or who elected to undergo a different type of hernia repair instead of a TEP procedure.
研究组 & 干预措施
PROLENE Polypropylene Tacking Mesh
Participants will be randomized to Tacking Mesh for their inguinal hernia surgery.
干预措施: PROLENE Polypropylene Tacking Mesh (Device)
ProGrip Self-fixating Mesh
Participants will be randomized to Self-fixing mesh for their inguinal hernia surgery
干预措施: ProGrip Self-fixating Mesh (Device)
结局指标
主要结局
Number of Participants With Early Postoperative Complications
时间窗: Within 30 days
Any complication which occurred within 30 days after the operation.
Mean Operative Time
时间窗: First incision to closure, approximately one hour
Length of time needed to complete surgery.
次要结局
- Pain Score at Baseline(baseline)
- Pain Score at One Week(One Week Postoperative)
- Pain Score at Four Weeks(Four Weeks Postoperative)
研究者
David R. Farley
Principal Investigator
Mayo Clinic