Comparison of Laparoscopic Totally Extraperitoneal (TEP) and Lichtenstein Technique in Long-term Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 主要终点
- early recurrence rate
研究概览
简要总结
Open tension-free mesh repair (Lichtenstein) and laparoscopic totally extraperitoneal (TEP) repair are the most commonly preferred techniques for inguinal hernia surgery. There's still a debate going on about which of these two techniques (open versus laparoscopic) is effective. This prospective randomized study aimed at comparing the early and long-term results of these two techniques (TEP vs. Lichtenstein).
详细描述
Various studies comparing the laparoscopic totally extraperitoneal (TEP) and Lichtenstein techniques have been reported. These studies have shown that TEP repair is associated with less postoperative pain and faster recovery. However, there are different views on the long-term (recurrence, chronic pain, etc.) results of the two techniques. This study was designed to compare the short- and long-term outcomes of open tension-free mesh repair technique(Lichtenstein) and laparoscopic repair technique(TEP).
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who were diagnosed with inguinal hernia (primary, recurrent, unilateral, bilateral)
- •American Society of Anesthesiologists (ASA) score of I and II
- •Gave informed consent to participate in the study
排除标准
- •Patients with scrotal, strangulated, or obstructed hernia
- •Periumbilical or subumbilical incision scar (median, right or left paramedian)
- •Undergoing prostatectomy or abdominal bladder surgery
- •Pfannenstiel incision scar
- •ASA score >3
结局指标
主要结局
early recurrence rate
时间窗: up to the first 3 months postoperatively
number of patients with recurrence
late recurrence rate
时间窗: Postoperative 3rd to 84th month
number of patients with recurrence
postoperative complication status
时间窗: up to the first 10 days postoperatively
number of patients with complications
early period complication status
时间窗: up to the first 3 months postoperatively
number of patients with complications
late period complication status
时间窗: Postoperative 3rd to 84th month
number of patients with complications
次要结局
- Visual Analog Score for pain(postoperative 24th hour)
- time to return to work after surgery(Postoperative 3rd month)
- total analgesic requirement(postoperative 1 to 10 days)
- early complication status(postoperative 1st month)
研究者
Adem Yuksel
Head of Gastroenterological Surgery
Kocaeli Derince Education and Research Hospital