Clinical outcomes of the new laparoscopic oesophago-hiatal DeltaMesh enhancement in 1351 hiatal Hernie patients

Praxis0 个研究点目标入组 1,351 人开始时间: 2021年2月2日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Inclusive criteria for all patients from 1/2007-12/2016: 1. substantial impairment of daily life caused by symptoms of hiatal instability regardless of size (giant hernia) or preceded fundoplication, age =15 years; 2. increasing A, B, C, or D symptoms; 3. cardia insufficiency, hiatal hernia, total organ dislocation, esophagitis with Savary Miller grade = 2 or Los-Angeles classification grade = B on endoscopy; 4. histopathologic findings of reflux esophagitis, ulceration, Barrett metaplasia, or dysplasia; 5. insufficient proton pump inhibitor (PPI) medication or adverse effects; and 6. availability of pathologic findings of pH measurement, manometry, X-ray contrast swallow, computed tomography (CT), or magnetic resonance imaging (MRI). The indication for surgery was based on criteria 1 and 2 (mandatory) and at least one or more additional criteria. Patient’s physical status was classified by the physical status classification system of the American Society of Anesthesiologists (ASA).

•Exclusion criteria were: age <15 years, suspicion of achalasia or malignancy, comorbidity that did not justify operative treatment, and doubts in diagnosis.

发起方

Praxis