Phrenoesophageal Ligament Reconstruction With Mesh: A New Approach to Hiatal Hernia Repair (Alinasser's Technique) for Adult Patients With Symptomatic Hiatus Hernia: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The recurrence rate of hiatal hernia by imaging and endoscopy
研究概览
简要总结
Introduction: The phrenoesophageal ligament (PEL) is a crucial structure that attaches the esophagus to the diaphragm, allowing for independent movement during respiration and swallowing. The ligament provides flexibility and strength, maintaining the integrity of the esophageal hiatus while accommodating pressure changes during breathing and swallowing. It consists of two limbs. The upper limb attaches the esophagus to the superior surface of the diaphragm, extending through the hiatus t'o insert into the esophagus 2-3 cm above it. The Lower Limb attaches the cardiac region of the stomach to the inferior surface of the diaphragm at the cardiac notch of the stomach. Failure and weakness of the PEL can predispose to esophageal HH and GERD symptoms. Understanding its anatomy is essential for the surgical management of hiatal hernia and GERD.
Purpose: To investigate the effectiveness and safety of a new technique for hiatal hernia repair (Alinasser's Technique of LHHR) using a mesh fixed to both the esophagus and crura, mimicking PEL, with a focus on reducing recurrence rates and improving patient outcomes. Methods: A randomized controlled trial study will be followed. The study will include 60 HH patients who will be randomized into either the intervention group (30 patients) who will undergo the new approach, or the classic group (30 patients) who will undergo the classic approach. Patients in the intervention group will undergo cruroplasty using a new technique (mesh applied like PEL). Importance: A new surgical technique is being applied for management of HH to decrease postoperative recurrence
详细描述
Diagnosis of GERD, esophagitis, and hiatus hernia:
Preoperative diagnosis We will use the GERD-Health-Related Quality of Life (GERD-HRQL) questionnaire to evaluate symptoms of GERD [11]. Preoperative assessment to diagnose HH by upper GIT endoscopy and a barium meal test in reverse Trendelenburg position. The Los Angeles system will be used for grading esophagitis [12]. 24 pH and esophageal manometry will be used to assess the esophageal motility and esophageal PH
Surgical technique:
Under general anaesthesia, Alinasser's Technique of LHHR will be carried out in the Frensh position. The pneumoperitoneum was created with CO2 pressures as high as 15 mmHg.
Procedure Position. The patient is positioned the French position, the surgeon stands in-between the legs and the assistants stand on either side of the patient, Steep reverse Trendelenburg positioning is often required. Port placement. We use a standard ports placement for most foregut procedures performed.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligibility criteria have been reformatted as follows:
- •#Inclusion Criteria:
- •Adult patients (≥18 years)
- •Symptomatic hiatus hernia
- •Primary hiatus hernia
- •Not responding to medical treatment
排除标准
- •Children (<18 years)
- •Recurrent hiatus hernia
- •Post-bariatric surgery
- •Pregnancy
- •Crohn's disease
- •Emergency surgery cases
研究组 & 干预措施
Classic approach (Standard of Care)
Standard Surgical Procedure Hiatal hernia repair no Mesh
干预措施: Classic approach (Procedure)
Hiatal Hernia Repair and Phrenoesophageal Ligament Reconstruction with Mesh (Alinasser technique)
A New Approach
干预措施: Phrenoesophageal Ligament Reconstruction with Mesh: A New Approach to Hiatal Hernia Repair (Alinasser's Technique) (Procedure)
结局指标
主要结局
The recurrence rate of hiatal hernia by imaging and endoscopy
时间窗: 12 Months Post- surgery
Imaging-based diagnosis: Most studies utilize radiological evaluation, such as esophagram (fluoroscopic imaging), CT scans, or barium swallow tests, to detect the anatomical recurrence of the hernia. Definitions of recurrence include any evidence of the stomach above the diaphragm or more than 2 cm of herniation above the diaphragm. Endoscopic assessment: Esophagogastroduodenoscopy (EGD) is also used to identify recurrences. Recurrence rate= (number of recurrent patient/total arm patient) x100
次要结局
未报告次要终点