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The Value of Lateral Release in Reconstruction of the Diaphragmatic Hiatus Hernia — PEH2  

Paraesophageal Hernia Clinical Trial

Official title:
The Value of Lateral Release in Reconstruction of the Diaphragmatic Hiatus in Patients With Type II-IV Paraesophageal Hernia. A Double Blind Randomized Study

Clinical Trial Summary

Patients scheduled for surgery for primary paraesophageal herniation are randomized to either conventional suturing of the crura or with the addition of lateral release.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04179578
Study type Interventional
Source Karolinska Institutet
Contact
Status Active, not recruiting
Phase N/A
Start date July 16, 2019
Completion date December 31, 2026
View Details
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