Clinical trial NCT04179578: The Value of Lateral Release in Reconstruction of the Diaphragmatic Hiatus Hernia
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Paraesophageal Hernia
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2019-11-27
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Crura plastic or crura plastic with the addition of "lateral release"
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Rat of reherniating
timeFrame: 1 year
Secondary outcomes:
measure: complications after operation
timeFrame: 1 year
measure: change in quality of life
timeFrame: 1 year
measure: Patients analgesic consumption after operation
timeFrame: 1 year
measure: Length of Stay (LOS)
timeFrame: 1 year
measure: sick leave period
timeFrame: 1 year
measure: GSRS Gastrointestinal Symptom Rating Scale
timeFrame: 1 year
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Ersta Hospital
state: Region Stockholm
Study officials:
affiliation: Karolinska Institutet
name: Anders Thorell, Professor
role: PRINCIPAL_INVESTIGATOR
References: