ACute Treatment of Incisional Ventral Hernia: an Italian Collaborative Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- 30-day morbidity
研究概览
简要总结
This observational, retrospective study aims to examine surgical outcomes in non-elective surgery for incisional hernia.
The main questions it aims to answer are:
- 30-day morbidity
- short- and long-term surgical outcomes
Data will be retrospectively collected from participating centers and compared. Researchers will compare surgical outcomes of the minimally invasive and laparotomic approaches to see if there are relevant differences in surgical outcomes.
详细描述
Incisional abdominal hernias are a common challenge for general surgeons, as a possible natural consequence of a considerable amount of abdominal wall trauma for laparotomic, laparoscopic, endoscopic, or robotic accesses.
In Italy, almost 17.000 cases per year of primitive and incisional hernias are diagnosed, leading to a wide necessity for surgical repair of abdominal wall defects, with a subsequent growing interest in the technical and technological aspects of this kind of surgery.
The real complexity of this kind of disease must be sought in various elements: different abdominal sites, different hernias' content, and a surgical approach that must aim to make abdominal wall repair as valid and definitive as possible.
For these reasons, a growing number of surgeons have ventured into abdominal wall surgery, with encouraging results and with techniques reproducible in many departments, expanding the surgical approach in this specific field, and getting a more anatomical and complete understanding of abdominal wall defects.
In the last years, minimally invasive surgery has taken place more and more, due to the evident advantages in terms of surgical outcomes, increasing the technical laparoscopic, endoscopic, and robotic knowledge worldwide.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both sexes,
- •≥ 18 years old
- •IH surgery in urgent/emergent settings
- •open or minimally invasive surgical approach
排除标准
- •Pregnant women
- •≥ 80 years old patients
- •primitive abdominal wall hernias
- •perineal or parastomal hernias
结局指标
主要结局
30-day morbidity
时间窗: first 30 days after surgery
(according to Clavien-Dindo classification) in patients who underwent abdominal wall repair for Incisional Hernia with/without prosthetic material in urgent/emergent settings, with the laparoscopic or the laparotomic approach.
次要结局
- 30-day mortality(first 30 days after surgery)
- 30-day hospital readmission rate(first 30 days after surgery)
- Reoperation rate(01 january 2018 - 31 December 2021)
- Short-term IH recurrence(01 january 2018 - 31 December 2021)
- Long-term IH recurrence(01 january 2018 - 31 December 2021)
研究者
Lorenzo Crepaz, MD
Principal Investigator
Ospedale San Camillo