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Active, Not Recruiting

NCT Number: NCT04179578

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Paraesophageal Hernia Hernia Hernia, Diaphragmatic Hernia, Hiatal Internal Hernia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ersta Hospital

Stockholm, Region Stockholm, 116 91, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Crura plastic

Procedure

Closure of hiatus with a running suture

Primary outcomes

  1. Rat of reherniating

    Time frame: 1 year

    computer tomography of abdomen and thorax

Secondary outcomes

  1. complications after operation

    Time frame: 1 year

    symptomatic recurrence

  2. change in quality of life

    Time frame: 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.

  3. Patients analgesic consumption after operation

    Time frame: 1 year

    information from the patient and the patient´s journal

  4. Length of Stay (LOS)

    Time frame: 1 year

    Information from the patient's journal

  5. sick leave period

    Time frame: 1 year

    Days, information from the patient

  6. GSRS Gastrointestinal Symptom Rating Scale

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study 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

Acronym: PEH2

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Nov 27, 2019
Registry last updated
Oct 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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