Can Gastropexy Improve the Efficacy of the Crural Repair in Patients with Paraesophageal Hernias? a Double Blind, Randomized, Multicenter Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 124
- 试验地点
- 12
- 主要终点
- Recurrence of hernia at 1 year after surgery
研究概览
简要总结
Patients scheduled for surgery for primary paraesophageal herniation are randomized to either conventional surgical hernia repair or with the addition of gastropexy.
详细描述
Patients scheduled for surgery due to primary paraesophageal herniation are randomized into either the control group or the interventional group.
Control Group: Patients undergo a crural repair combined with a short and floppy Nissen fundoplication.
Interventional Group: In addition to the crural repair and Nissen fundoplication, patients receive a gastropexy. This involves the fixation of the posterior part of the wrap the right crus, the left portion of the wrap to the diaphragm, and the minor curvature of the stomach to the abdominal wall.
Follow-Up Assessments:
Imaging: Computed tomography (CT) scans are performed before surgery and at 1 and 3 years postoperatively to evaluate anatomical outcomes.
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
- •Patients diagnosed with a primary paraesophageal hernia (hiatal hernia types II-IV) who are scheduled for elective or emergency surgical repair at participating centers
排除标准
- •Previous major upper gastrointestinal (GI) surgery, including prior hiatal hernia repair.
- •Diagnosis of achalasia or any other significant esophageal motility disorder.
- •Inability to understand the purpose of the study and/or inability or unwillingness to provide informed consent.
- •Severe comorbidities, defined by an American Society of Anesthesiologists (ASA) physical status score of greater than III.
结局指标
主要结局
Recurrence of hernia at 1 year after surgery
时间窗: 1 year
Computer tomography of abdomen and thorax
次要结局
- Recurrence of hernia at 3 years after surgery(3 year)
- Complications after surgery(30 days after surgery)
- Length of stay at the hospital after surgery(30 days after surgery)
- Changes in the patients perception of quality of life after surgery(3 months, 12 months, and 36 months)
- Changes in the patients perception of gastrointestinal symptoms after surgery(3 months, 12 months, and 36 months)
- Changes in the patients perception of dysphagia after surgery(3 months, 12 months, and 36 months)
- Changes in the patients perception of dysphagia and reflux frequency after surgery(3 months, 12 months, and 36 months)
研究者
Marcus Reuterwall Hansson
PhD, senior consultant surgeon
Ersta Diakoni