CSP #456 - Tension Free Inguinal Hernia Repair: Comparison of Open and Laparoscopic Surgical Techniques
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,200
- 试验地点
- 28
- 主要终点
- To assess recurrence rates, operative complications, pain, convalescent time, health-related quality of life, patient satisfaction, and health care utilization and costs.
研究概览
简要总结
Inguinal hernia is one of the most common worldwide afflictions of men. The presence of an inguinal hernia is indication for its repair. Approximately 700,000 hernia repairs are performed in the U.S. each year, and this procedure accounts for 10% of all general surgery procedures in the Veterans Health Administration (VHA) (10,000 inguinal herniorrhaphies performed per year). There are many different techniques currently in use for repairing inguinal hernias and with the advent of laparoscopy, yet another technique is being advocated. Laparoscopic repair has been reported in some studies to be superior to open repair because of less pain and earlier return to work. However, laparoscopic repair requires a general or regional anesthetic and expensive equipment and supplies to perform. There is also evidence that open tension-free mesh repair may have results similar to laparoscopic repair for these patient centered outcome measures. The general acceptance of this procedure, especially in the VHA, has not been uniform. Furthermore, no randomized trial of sufficient size and power to be conclusive has been done to set forth the operative "gold standard" for hernia repair.
详细描述
Primary Hypothesis: Open tension-free herniorrhaphy when compared with laparoscopic herniorrhaphy will achieve equal or better recurrence rates and lower costs while achieving equivalent outcomes for patient-centered measures.
Secondary Hypotheses:
Intervention: Patients randomized to open repair will undergo a standardized tension-free herniorrhaphy with prosthesis (method of Lichtenstein). Patients randomized to laparoscopic herniorrhaphy will undergo a standardized preperitoneal repair with prosthesis, using either a transperitoneal or extraperitoneal approach. During the implementation period of the trial, a preliminary laboratory session will be conducted with all site PIs to standardize herniorrhaphy techniques, reach consensus on all aspects of perioperative patient management (including postoperative patient instructions, follow-up schedules, definitions of recurrence and complications), and to ensure that the site PI is thoroughly familiar with the protocol.
Each site will be visited by one of two expert surgeons (the Study Chair or a Co-PI surgeon) to observe the operative procedures and ensure that participating surgeons adhere to the protocol in all respects. The first visit will take place in the first 6 months of the study and then as needed thereafter, based on routine examination of operative records randomly selected from each site (5 open and 5 laparoscopic herniorrhaphies, and, if appropriate, viewing of videotapes of the laparoscopic procedures).
Primary Outcomes: Hernia recurrence rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
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
- •Men with inguinal hernia.
排除标准
- 未提供
结局指标
主要结局
To assess recurrence rates, operative complications, pain, convalescent time, health-related quality of life, patient satisfaction, and health care utilization and costs.
时间窗: Two years
次要结局
未报告次要终点