Partial Versus Total Fundoplication in the Surgical Repair of Para-esophageal Hernia. Results of a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Ogilvie dysphagia score
研究概览
简要总结
Short-term follow up after surgery of para-esophageal hernia comparing two different types of fundoplication
详细描述
Laparoscopic para-esophageal hernia (PEH) repair has been established as a safe and effective treatment for symptomatic patients. Today, most surgeons agree that a fundoplication should be included in the hiatal reconstruction in order to reduce the risk of postoperative gastroesophageal reflux and hernia recurrence. However, what type of wrap that should be recommend is yet to be determined.
One might argue that the overall durability and effectiveness of a partial fundoplication in the control of reflux might be less reliable than a total wrap, but on the contrary, the latter carries the risk of inducing a pseudoachalasia similar situation in PEH patients.
We therefore designed a double blind randomized clinical trial in which patients with symptomatic paraesophageal hernia to receive either a posterior partial (Toupet) or total (Nissen) fundoplication after hernia reduction and crural repair.
Six months follow up with questionnaires, 24-hour pH monitoring and radiology after surgery of para-esophageal hernia with addition of total fundoplication vs posterial partial fundoplication.
Dysphagia Scores; Ogilvie dysphagia score and Watson dysphagia score. Quality of Life; SF-36: physical and mental component scores.
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
- Double (Participant, Investigator)
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 undergoing acute or elective surgery for symptomatic PEH at Ersta Hospital and Karolinska University Hospital
排除标准
- •age below 18 years
- •axial sliding hiatal hernia only (type I)
- •missing informed consent
- •previous hiatal hernia surgery
- •American Society of Anesthesiologists (ASA) score IV or above
- •achalasia
- •Zollinger-Ellison syndrome
- •malignant tumor
- •inability or unwillingness to complete questionnaires
结局指标
主要结局
Ogilvie dysphagia score
时间窗: 6 months
The Ogilvie dysphagia score is a 5-graded scale 0-4 defined as follows: '0', ability to eat ordinary diet; '1', ability to swallow solid food; '2', ability to swallow semisolids; '3', ability to swallow liquids; '4', total inability to swallow .
次要结局
- Acid reflux control(6 months)
- intra-and postoperative courses(6 mohths)
- length of hospital stay(6 months)
- Watson dysphagia score(6 months)
- Quality of Life (SF-36)(6 months)
- Radiology(6 months)
研究者
Lars Lundell
Professor
Karolinska University Hospital