Comparison of Hybrid and Laparoscopic Incisional Hernia Repair: A Prospective Randomized Multicentre Study
试验速览
- 阶段
- 不适用
- 入组人数
- 160
- 主要终点
- number of patients with seroma formation
研究概览
简要总结
Study is a prospective, multicenter, randomized trial evaluating two laparoscopic incisional hernia repair methods: basic laparoscopic mesh repair (lap.) and a hybrid repair (laparoscopic mesh and fascial suturation).
Patients are recruited prospectively from 10 Finnish Hospitals (Oulu, Jorvi, Hyvinkää, Kotka, Seinäjoki, Valkeakoski, Lahti, Kuopio, Kokkola, Loimaa).
Patients are randomized to operative groups (lap. vs hybrid).
Follow-up visits are scheduled at 1- and 12-month after surgery. Patients are evaluated for their clinical status and an ultrasound scan is performed. QoL-questionnaire and pain score (VAS) are reported.
The primary end-points:
- clinically and/or radiologically detected seroma in 1 month control
- clinically and/or radiologically detected recurrent hernia in 1 year control
The secondary end-points:
- peri-and postoperative outcomes/ complications, morbidity, mortality
- duration of hospital stay
- pain scale (VAS)
- Quality of Life (SF/Rand36)
详细描述
Hypothesis
Using a hybrid method seroma formation and hernia recurrence can be diminished.
Patient exclusion criteria:
Age< 18 y or > 80 y ASA >4 (the American Society of Anaesthesiologists' classification of Physical Health) BMI> 40 A previous mesh repair of the hernia Hernia defect size <2 or >7 cm Emergency operation
Eligible patients are randomized into two operative groups (lap/hybrid). In the laparoscopic group the hernia defect is covered with a Parietex composite mesh (using minimum of 5 cm marginals, Securestrap fixation instrument and four lifting strings. In hybrid group the hernia sack is resected and fascial defect is sutured through a minilaparotomy incision. After this, a mesh repair is performed laparoscopically.
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
- None
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 with incisional hernia
排除标准
- •a Prior mesh repair
- •Hernia defect size <2 or >7 cm
- •Emergency operation
结局指标
主要结局
number of patients with seroma formation
时间窗: 1 month
number of patients with hernia recurrence
时间窗: 1 year
次要结局
- VAS pain scale(1 year)
- Quality of Life(preoperative-1month-1year)
- number of patients with peri/postoperative complications(up to 1 year)
研究者
Mirella Ahonen-Siirtola
MD
Oulu University Hospital