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

Study Overview
=================
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.

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

Conditions
-----------------
Paraesophageal Hernia

Intervention / Treatment
-----------------
* Procedure: Crura plastic


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Crura plastic or crura plastic with the addition of lateral release
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Crura<br>Closure of the diaphragmatic hiatus by a running suture alone | Procedure: Crura plastic<br>* Closure of hiatus with a running suture<br>|
| Active Comparator: Crura and lateral release<br>Closure of the diaphragmatic hiatus by a running suture and an incision of 4 cm of the left diaphragm (lateral release) | Procedure: Crura plastic<br>* Closure of hiatus with a running suture<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rat of reherniating | computer tomography of abdomen and thorax | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complications after operation | symptomatic recurrence | 1 year | 
| change in quality of life | SF-36 (Quality of Life issues) The SF-36 It is comprised of 36 items that assess eight health concepts: physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain, and general health perceptions. Physical and mental health summary scores are also derived from the eight RAND-36 scales. Higher scores mean a better outcome. | 1 year | 
| Patients analgesic consumption after operation | information from the patient and the patient´s journal | 1 year | 
| Length of Stay (LOS) | Information from the patient's journal | 1 year | 
| sick leave period | Days, information from the patient | 1 year | 
| GSRS Gastrointestinal Symptom Rating Scale | Scoring;The questionnaire, which contains 15 items, uses a seven-graded Likert scale, where 1 represents the most positive option and 7 the most negative one. A mean value for the items in each dimension should be calculated: Diarrhoea syndrome: 11. Increased passage of stools 12. Loose stools 14. Urgent need for defecation Indigestion syndrome: 6. Borborygmus 7. Abdominal distension 8. Eructation 9. Increased flatus Constipation syndrome: 10. Decreased passage of stools 13. Hard stools 15. Feeling of incomplete evacuation Abdominal pain syndrome: 1. Abdominal pain 4. Sucking sensations 5. Nausea and vomiting Reflux syndrome: 2. Heartburn 3. Acid regurgitation | 1 year |