: Outcomes of Trasversus Abdominis Release for Complex Abdominal Wall Hernia Repair: an Italian Multicenter Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 432
- 试验地点
- 2
- 主要终点
- Hernia Recurrence
研究概览
简要总结
This multicenter retrospective study analyzed data from 308 patients who underwent open Posterior Component separation with Trasversus release for primary or recurrent complex abdominal hernias between 2015 and 2020. The primary endpoint was the rate of Hernia Recurrence and Mesh Bulging at 3, 6, 12, 24, and 36 months. Secondary outcomes included surgical site events and were assessed using the Pain scale.
详细描述
Study design This study is reported according to the STROBE statement for cohort studies A retrospective multicentric study was conducted to analyze the surgical outcomes of patients undergoing open with Posterior Component separation with Trasversus release for inisional hernia. It was conducted according to the ethical principles stated in the Declaration of Helsinki. Written informed consent was obtained from all subjects.
Study setting and study population From January 2015 and May 2020, all the patients affected by primary or recurrent complex abdominal hernias undergoing open Posterior Component separation with Trasversus release referring to 6 centers, were considered for enrollment in the study. Inclusion criteria were age ≥16 years, primary or recurrent complex abdominal hernias with more than >10 cm midline defects Exclusion criteria were follow-up data lower than 36 months, patients with a stoma for whom closure was not planned during the abdominal hernia repair
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥16 years,
- •primary or recurrent complex abdominal hernias with more than >10 cm midline defects
排除标准
- •follow-up data lower than 36-months, patients with a stoma for whom closure was not planned during the abdominal hernia repair
结局指标
主要结局
Hernia Recurrence
时间窗: 36 months
In details, Hernia Recurrence was clinically defined as any visible or palpable ''blowout'' in the abdominal wall. computed tomography scan evaluation was carried out by a radiologist with 10 years of gastrointestinal computed tomography scan experience.
Mesh Bulging
时间窗: 36 months
In details, Mesh Bulging was clinically defined as any visible or palpable ''blowout'' in the abdominal wall. computed tomography scan evaluation was carried out by a radiologist with 10 years of gastrointestinal computed tomography scan experience.
surgical site events
时间窗: 1 months
Regarding the surgical site events, the classification of wound events was assigned according to the likelihood and degree of wound contamination at the time of the operation, as stated in the Centre for Disease Control and Prevention wound classification (superficial, deep or organ space)
Number of patients affected by Superficial surgical site infection
时间窗: 1 months
Superficial infections according to Clavien-Dindo criteria
次要结局
- Number of patients affected by Superficial surgical site infections(Within 30 days postoperatively)
- Number of patients affected by organ space infections(Within 30 days postoperatively)
- Number of patients affected by Surgical Site Occurence(Within 30 days postoperatively)
- Number of patients affected by Deep surgical site infections(Within 30 days postoperatively)
- Postoperative pain(Postoperative pain will be recorded according to visual analogue scale Visual Analogue Scale at 36 month.)
研究者
Francesco Pizza
MD,PhD, Responsible for the Bariatric and Metabolic Surgery unit
Azienda Sanitaria Locale Napoli 2 Nord