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

Not Applicable

Active, not recruiting

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Crura	Crura plastic	Closure of the diaphragmatic hiatus by a running suture alone
Crura and lateral release	Crura plastic	Closure of the diaphragmatic hiatus by a running suture and an incision of 4 cm of the left diaphragm (lateral release)

Primary Outcome Measures

Name	Time	Method
Rat of reherniating	1 year	computer tomography of abdomen and thorax

Secondary Outcome Measures

Name	Time	Method
complications after operation	1 year	symptomatic recurrence
sick leave period	1 year	Days, information from the patient
Patients analgesic consumption after operation	1 year	information from the patient and the patient´s journal
Length of Stay (LOS)	1 year	Information from the patient's journal
change in quality of life	1 year	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.
GSRS Gastrointestinal Symptom Rating Scale	1 year	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