NCT04179578

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Paraesophageal Hernia

Interventions

Type	Name	Description
PROCEDURE	Crura plastic	Closure of hiatus with a running suture

Timeline

• Start date: 2019-07-16
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2019-11-27
• Last updated: 2024-10-22

Locations

1 site across 1 country: Sweden