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

Paraesophageal Hernia Clinical Trial

— PEH2  

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 Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04179578
• Other study ID #: 2019-02801
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 16, 2019
• Est. completion date: December 31, 2026

Study information

• Verified date: October 2023
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Hiatal
• Paraesophageal Hernia

Intervention

Procedure:
• Crura plastic
Closure of hiatus with a running suture

Locations

Country	Name	City	State
Sweden	Ersta Hospital	Stockholm	Region Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rat of reherniating	computer tomography of abdomen and thorax	1 year
Secondary	complications after operation	symptomatic recurrence	1 year
Secondary	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
Secondary	Patients analgesic consumption after operation	information from the patient and the patient´s journal	1 year
Secondary	Length of Stay (LOS)	Information from the patient's journal	1 year
Secondary	sick leave period	Days, information from the patient	1 year
Secondary	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