Clinical Trials Logo
  1. Home
  2. Paraesophageal Hernia
  3. NCT04179578

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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT00786084 - Study of Paraesophageal Hernia Repair With Small Intestine Submucosa N/A
Recruiting NCT05974722 - Mesh Vs Pledgets for Repair of Paraesophageal Hernia N/A
Recruiting NCT01799967 - Minimally Invasive Surgery of the Gastro-esophageal Junction
Completed NCT01776827 - Long-term Outcome of Laparoscopic Hiatal Hernia Repair With or Without Alloderm Mesh at a University Hospital
Completed NCT04436159 - Partial Versus Total Fundoplication in the Surgical Repair of Para-esophageal Hernia. N/A
Completed NCT04007952 - Anterior Gastropexy vs. No Anterior Gastropexy for Paraesophageal Hernia Repair N/A
Not yet recruiting NCT06096402 - Gastropexy as a Treatment Option for Paraesophageal Hernia
Recruiting NCT06107634 - Gastropexy in the Repair of Patients With Paraesophageal Hernias N/A
Completed NCT00272922 - Randomized, Prospective Controlled Trial of Paraesophageal Hernia Repair With Small Intestinal Submucosa (SIS) N/A
Recruiting NCT05201508 - Sutures Versus Polyglactin Mesh in Hiatal Hernia Repair N/A
Completed NCT01587859 - Short Esophagus in Type II-IV Hiatus Hernia N/A
Completed NCT01606449 - Follow-up of Patients Operated Upon for Type II-IV Hiatal Hernia N/A
Enrolling by invitation NCT05807763 - Fundoplication in Laparoscopic PEH Repair Based on FLIP N/A
Completed NCT03058731 - ACELL Mesh for Paraesophageal Hernia Repair
Recruiting NCT06193551 - Ovitex in Paraesophageal and Large Hiatal Hernia Repair N/A
Completed NCT01099033 - The Biologic Basis of Hernia Formation