Laparascopic Keyhole vs Sugarbaker Repair in Parastomal Hernia: A Long Term Case-controlled Prospective Study of Consecutive Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Recurrence
研究概览
简要总结
This is a non-randomised case-controlled prospective study of consecutive patients with parastomal hernia, comparing the laparoscopic Keyhole repair with the modified Sugarbaker repair.
详细描述
Objective
To compare the laparoscopic Keyhole repair with the modified Sugarbaker repair in a nonrandomised case-controlled prospective study of consecutive patients with parastomal hernia.
Summary Background Data: Two reviews of uncontrolled studies concluded that the Sugarbaker repair is superior to the Keyhole repair. The present study challenges the claim.
Methods: In two time periods 135 patients with a parastomal hernia were repaired with the Keyhole technique (74 patients, using a two-layer mesh of polypropylene and ePTFE with a self-cut slit, 1997- 2009) or the Sugarbaker technique (61 patients, using a coated polypropylene mesh, 2009-2015). The patients in the two groups matched with regard to age, gender, ASA score, colostomy or ileostomy hernia, previous repairs, size of fascial defect and simultaneous repair of a concurrent incisional hernia. Observation time was defined as time to recurrence, stoma re-siting, mesh removal, death, or last non-event visit
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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 with a diagnosis of parastomal hernia and indication for surgical treatment -
排除标准
- 未提供
结局指标
主要结局
Recurrence
时间窗: 3 years
Recurrence of parastomal hernia
次要结局
- Postoperative complications(30 days after surgery)
- Mesh-related morbidity(3 years)
研究者
Vitaly Alexandrovich Gameza
MD
Aalborg University Hospital