Absorbable Versus Permanent Mesh Fixation Trial in Laparoscopic Midline Ventral Hernia Repair (SORBET Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 11
- 主要终点
- number of patients with a VAS scale more than 40
研究概览
简要总结
To compare the use of absorbable tackers versus permanent tack fixation using a polyester large pore mesh in laparoscopic midline ventral hernia repair in a multicenter (Belgian) prospective randomized single-blinded trial.
All patients referred for elective midline ventral hernia repair should be assessed for eligibility and entered in a study log, detailing all included patients during the study period.
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
- Single (Participant)
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
- •written informed consent from the adult patient (18 years and older, no maximum age)
- •primary, incisional or recurrent midline ventral hernia requiring elective laparoscopic repair
排除标准
- •no written informed consent
- •hernia defects larger than 10cm diameter in width
- •'hostile' abdomen; open abdomen treatment
- •contraindication to pneumoperitoneum
- •emergency surgery (incarcerated hernia)
- •lateral or parastomal hernia sites
研究组 & 干预措施
absorbable fixation left side
干预措施: permanent mesh fixation (Device)
absorbable fixation left side
干预措施: absorbable mesh fixation (Device)
absorbable fixation right side
干预措施: permanent mesh fixation (Device)
absorbable fixation right side
干预措施: absorbable mesh fixation (Device)
结局指标
主要结局
number of patients with a VAS scale more than 40
时间窗: 1 year after surgery
The Visual Analogue Scale (VAS) is commonly used to measure the intensity of pain or other subjective experiences. It is a simple and effective tool. The VAS consists of a straight line, usually 10 cm long, with endpoints defining extreme limits such as 'No pain' and 'Worst imaginable pain'. Respondents mark a point on the line that represents their perception of their current state. Scoring: Scale Title: Visual Analogue Scale (VAS) Minimum Value: 0 (indicating no pain or the least possible experience of the measured parameter) Maximum Value: 10 (indicating worst imaginable pain or the most extreme experience of the measured parameter) Higher Scores: Indicate a worse outcome (e.g., more intense pain or greater severity of the measured parameter).
次要结局
- recurrence rate(1 year post-surgery)
- perioperative morbidity rate(1 year after surgery)
- number of invasive interventions (local infiltrations, reoperations) postoperatively(1 year after surgery)
- number of patients taking analgetics using MCGill painscore(1 year post-surgery)
- quality of life by using EQ5D score(1 year post-surgery)