Paraesophageal HerniaPEH2NCT04179578
The Value of Lateral Release in Reconstruction of the Diaphragmatic Hiatus Hernia
A study testing Crura plastic in people with Paraesophageal Hernia, run by Karolinska Institutet at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paraesophageal Hernia
- What is being tested?
- Crura plastic
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteSweden
- Study dates
- 16 Jul 2019to 17 Jun 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all patients with primary hiatus hernia type II-IV who are deemed suitable for surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Patients scheduled for surgery for primary paraesophageal herniation are randomized to either conventional suturing of the crura or with the addition of lateral release.
Read the 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.
- Conditions
- Paraesophageal Hernia
- Being tested
- Crura plastic
- Medical subject headings
- Hernia, Hiatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crura plasticProcedure or surgery
Closure of hiatus with a running suture
| Study group | Role | What they receive |
|---|---|---|
| Crura | Active comparator | Closure of the diaphragmatic hiatus by a running suture alone Receives: Procedure: Crura plastic |
| Crura and lateral release | Active comparator | Closure of the diaphragmatic hiatus by a running suture and an incision of 4 cm of the left diaphragm (lateral release) Receives: Procedure: Crura plastic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rat of reherniating
computer tomography of abdomen and thorax
Measured: 1 year
Secondary outcomes (6)
complications after operation
symptomatic recurrence
Measured: 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.
Measured: 1 year
Patients analgesic consumption after operation
information from the patient and the patient´s journal
Measured: 1 year
Length of Stay (LOS)
Information from the patient's journal
Measured: 1 year
sick leave period
Days, information from the patient
Measured: 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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start16 Jul 2019
- Primary completion22 Mar 2024
- Study completion17 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Paraesophageal HerniaStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Crura plastic or crura plastic with the addition of "lateral release"
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anders Thorell, Karolinska Institutet
- Investigators
- Anders Thorell, Professor, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04179578
- Sponsor's protocol ID
- 2019-02801
- Other IDs
- 2019
- Acronym
- PEH2
- Status last verified
- Oct 2026
- First submitted
- 7 Nov 2019
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tsoposidis A, Thorell A, Axelsson H, Reuterwall Hansson M, Lundell L, Wallenius V, Kostic S, Hakanson B. The value of "diaphragmatic relaxing incision" for the durability of the crural repair in patients with paraesophageal hernia: a double blind randomized clinical trial. Front Surg. 2023 Nov 10;10:1265370. doi: 10.3389/fsurg.2023.1265370. eCollection 2023.
PubMed 38026477