The Value of Lateral Release in Reconstruction of the Diaphragmatic Hiatus in Patients With Type II-IV Paraesophageal Hernia. A Double Blind Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Rat of reherniating
研究概览
简要总结
Patients scheduled for surgery for primary paraesophageal herniation are randomized to either conventional suturing of the crura or with the addition of lateral release.
详细描述
Patient undergoing surgery for primary paraesophageal herniation, are randomized to either conventional suturing of the diaphragmatic crura only or with the addition of a diaphragmatic incision "lateral release".
The patients are examined by computed tomography before surgery and at 1 and 3 years after surgery.
SF-36 (global quality of Life instrument), GSRS (Gastrointestinal Symptoms Rating Scale), Reflux frequency issues and Watson's dysphagia score are completed before and at 3 and 6 month as well as 1 and 3 years after surgery.
Patients undergoing laparoscopic repair for paraesophageal hernia Type II-IV are eligible for inclusion in the study. Included patients will be randomized to either reconstruction of the hiatus by suturing of the crura alone or in combination with an approximately 4 cm incision of the anterior aspect of the left diaphragma "lateral release" before crural suturing. The incision will be covered with a synthetic patch after crural closure is finished. All other aspects of the surgical procedure are similar in the two groups including complete mobilization of the hernia sac before and a total fundoplication after hiatal restoration, respectively.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The randomization process is initiated after general anesthesia is induced and the group affiliation will be determined by opening of a sealed envelope specifying the group assignment. The information of group allocation is stored in a closed envelope kept in a locked archive until the study is completed.
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
- •all patients with primary hiatus hernia type II-IV who are deemed suitable for surgery
排除标准
- •inability to understand the nature of the purpose of the study and/or to give informed consent.
- •American Society of Anesthesiologists physical status-system (ASA) >III
- •Achalasia or another severe esophageal motor disorder
结局指标
主要结局
Rat of reherniating
时间窗: 1 year
computer tomography of abdomen and thorax
次要结局
- sick leave period(1 year)
- Patients analgesic consumption after operation(1 year)
- Length of Stay (LOS)(1 year)
- complications after operation(1 year)
- change in quality of life(1 year)
- GSRS Gastrointestinal Symptom Rating Scale(1 year)
研究者
Anders Thorell
Professor
Karolinska Institutet