Randomized Clinical Trial to Compare TAPP vs TEP Approach for Women's Inguinal Hernia on an Outpatient Basis
试验速览
- 阶段
- 不适用
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Recurrence
研究概览
简要总结
Open prospective randomised clinical trial enrolling women who suffer from inguinal or femoral hernia, to evaluate if TEP approach is superior to TAPP concerning postoperative development, principally postoperative pain, with no increase of recurrent hernia at the one-year follow-up visit.
详细描述
Randomised phase IV clinical trial enrolling women suffering from inguinal hernia in Virgen del Rocío University Hospital influence area, from March 2019 to March 2021.
The aim of the study is to conclusively stablish whether there is real and significant benefit in using TEP approach over TAPP, in an outpatient basis, concerning postoperative evolution. Secondary objectives are the assessment of postoperative pain, using VAS (visual analogic scale), of both techniques, and evaluation of hernia recurrence during the first postoperative year The individuals will be assigned to each group according to simple random sampling.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Inguinofemoral hernia, EHS (European Hernia Society) classification.
- •Patient over 18 years old.
- •Signed informed consent form.
- •Meeting of outpatient discharge criteria, determined by Aldrete´s test
排除标准
- •Loss of domain.
- •Abdominal skin grafts.
- •Previous preperitoneal (open or laparoscopic) prosthetic mesh.
- •Incarcerated hernia.
- •Previous complications such as infection, fistulae...
- •Not candidate for ambulatory surgery
- •Pregnancy or desire for pregnancy in the first postoperative year
结局指标
主要结局
Recurrence
时间窗: One year
Recurrence of inguinal hernia in the one-year follow-up
Post operative pain
时间窗: 24 hours
Post operative pain, measured with Visual Analogue Scale (VAS) (from 0 to 10 points) World Health Organization (WHO)
Complications
时间窗: One year
Postoperative complications including wound complications (seroma, haematoma, infection), gastrointestinal complications (ileus, fistula), urological complications (acute retention, haematuria) and hernia complications (recurrence, chronic groin pain) will be reported. Occurrence of major complications will be registered, including intestinal injury, major vascular lesion, bleeding over 500cc and peritonitis.
次要结局
- Operating time(180 minutes)
- Hospital stay(24 hours)
研究者
José Tinoco González
Principal Investigator
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla