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

Karolinska Institute

Status: Active, not recruiting

Conditions: Paraesophageal Hernia

Treatments: Procedure: Crura plastic

Study type: Interventional

Funder types: Other

Identifiers

NCT04179578

2019-02801

Details and patient eligibility

About

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

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• all patients with primary hiatus hernia type II-IV who are deemed suitable for surgery

Exclusion criteria

• inability to understand the nature of the purpose of the study and/or to give informed consent.
• American Society of Anesthesiologists physical status-system (ASA) >III
• Achalasia or another severe esophageal motor disorder

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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70 participants in 2 patient groups

Crura

Active Comparator group

Description:

Closure of the diaphragmatic hiatus by a running suture alone

Treatment:

Procedure: Crura plastic

Crura and lateral release

Active Comparator group

Description:

Closure of the diaphragmatic hiatus by a running suture and an incision of 4 cm of the left diaphragm (lateral release)

Treatment:

Procedure: Crura plastic