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

The Value of Lateral Release in Reconstruction of the Diaphragmatic Hiatus in Patients With Type II-IV Paraesophageal Hernia. A Double Blind Randomized Study

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

Study Overview

• Status: Active, not recruiting
• Conditions: Paraesophageal Hernia
• Intervention / Treatment: Procedure: Crura plastic

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.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anders Thorell, Professor; Phone Number: +46 8 714 6541; Email: anders.thorell@ki.se

Study Locations

• Sweden
  • Region Stockholm
    • Stockholm, Region Stockholm, Sweden, 116 91
      • Ersta Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: Anders Thorell, Professor, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2019
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: November 7, 2019
• First Submitted That Met QC Criteria: November 25, 2019
• First Posted (Actual): November 27, 2019

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: October 2, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Diaphragmatic; Internal Hernia; Hernia; Hernia, Hiatal
• Other Study ID Numbers: 2019-02801

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No