Comparison Between Laparoscopic and Open Repair of Perforated Gastroduodenal Peptic Ulcer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 13
- 主要终点
- 30-day Mortality Rate
研究概览
简要总结
Although laparoscopic repair (LR) of perforated peptic ulcers (PPUs) has long been accepted, clinical evidence comparing LR versus open repair (OR) remains lacking. The aim of this study is to evaluate the feasibility, safety and outcome of laparoscopic gastric repair and compare it with the outcome open repair by relying on a propensity score matching statistical technique
详细描述
Despite the evolution of medical management of Gastroduodenal Peptic Ulcer (GPU), complications like bleeding and perforation are still not uncommon in clinical practice. According to the literature in average, 2-14% of peptic ulcers result in perforation, most 215 commonly occurring in females over the age of 60 and chronic NSAID, alcohol or tobacco users.
Management of perforated peptic ulcer entails resuscitation, pharmacotherapy and surgery.
Traditionally, suture with or without omental patch has been considered the 'gold standard' and still is. It is associated with shorter length of stay, lower transfusion needs and has lower morbidity as compared to gastrectomy. In 1992, it has been proposed that laparoscopy should be routinely considered in the management of perforated duodenal ulcer. Nowadays due to the advances in laparoscopic technique, many publications suggest that laparoscopic repair of perforated peptic ulcers could be a superior choice to open repair. These is linked with the advantages of laparoscopic surgery over open surgery such as reduced postoperative pain, lower wound infection rate, decreased length of hospital stay, and earlier functional recovery
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients surgically treated for benign peptic ulcer perforation
排除标准
- •Age < 18 years
- •Pregnant and breastfeeding women
- •Malignant ulcer perforation
- •Gastric resection
- •Diagnostic laparoscopy/laparotomy with no further surgical procedures performed
结局指标
主要结局
30-day Mortality Rate
时间窗: 18 months
30-day Morbidity Rate
时间窗: 18 months
Morbidity defined by mean of the most used classification scoring system
次要结局
- Operative time(18 months)
- Conversion rate(18 months)
- Calculation of Boey index(18 months)
- Calculation of Mannheim Peritonitis Index(18 months)
- Calculation of Shock index(18 months)
- Calculation of Age-related shock index(18 months)
- Calculation of Charlson Age-Comorbidity Index (CACI)(18 months)
研究者
Gianluca Costa
Professor
University of Roma La Sapienza