Does Inversion and Fixation of the Transversalis Fascia Prevent Postoperative Seroma Formation in Patients Undergoing Laparoscopic Inguinal Hernia Repair?
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Seroma formation rate
研究概览
简要总结
According to the EHS classification, at least 80 patients who will undergo TEP repair for the first time with the diagnosis of M2 and M3 direct inguinal hernia will be randomized into 2 groups. After direct hernia reduction in the patients in the first group, the transversalis fascia at the hernia site will be pulled inward and fixed to the Cooper ligament with 2 or 3 absorbable tackers. Standard surgery will then be continued. The patients in the second group will undergo standard surgery without any seroma prevention procedure. Demographic data, clinical/radiological seroma rate, postoperative pain (VAS values),quality of life(SF36 questionnaire), recurrence and other complications at postoperative 1st, 7th day, 3rd and 6th month will be monitored. When the desired number of patients and the follow-up period are reached, the data in the 2 groups will be compared.
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, Investigator)
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
- •Clinical or/and radiological diagnosis of primary inguinal hernia
- •EHS type M2 and M3 direct hernias
- •Laparoscopic totally extraperitoneal (TEP) repair
排除标准
- •Indirect hernias
- •M1 direct hernias
- •Recurrent hernias
- •Patients with previous groin operations on same side
- •Pregnant women
- •Patients who did not accept to participate in the study
- •ASA score of 3 or higher,
研究组 & 干预措施
Active Group
Patients who underwent transversalis fascia inversion during TEP
干预措施: Transversalis Fascia Inversion (Procedure)
Control Group
Patients who did not undergo transversalis fascia inversion during TEP
结局指标
主要结局
Seroma formation rate
时间窗: 3 month
The clinical/radiological seroma formation rates between the groups with and without transversalis fascia inversion and fixation.
次要结局
- Postoperative pain levels(1 day)
- Pain levels(7 day)
- Chronic pain and quality of life measures(3 month)
研究者
Erol Aydın
MD
Istanbul Training and Research Hospital