Paraesophageal HerniaPEH3NCT06107634
Gastropexy in the Repair of Patients With Paraesophageal Hernias
A study testing Gastropexy and Paraesophageal hernia repair in people with Paraesophageal Hernia, run by Ersta Diakoni at 6 sites in Sweden.
Trial summary
Patients scheduled for surgery for primary paraesophageal herniation are randomized to either conventional surgical hernia repair or with the addition of gastropexy. 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?
- Gastropexy and Paraesophageal hernia repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 6 sitesSweden
- Study dates
- 1 Jun 2023to 30 Nov 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients diagnosed with a primary paraesophageal hernia (hiatal hernia types II-IV) who are scheduled for elective or emergency surgical repair at participating centers
Who cannot join
- Previous major upper gastrointestinal (GI) surgery, including prior hiatal hernia repair.
- Diagnosis of achalasia or any other significant esophageal motility disorder.
- Inability to understand the purpose of the study and/or inability or unwillingness to provide informed consent.
- Severe comorbidities, defined by an American Society of Anesthesiologists (ASA) physical status score of greater than III.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Sweden6 sites
Sahlgrenska University Hospital
Gothenburg, 413 45
Skåne University Hospital Lund
Lund, 221 85
Nyköping Hospital
Nyköping, 611 85
Ersta Hospital
Stockholm, 11691
Sundsvall County Hospital
Sundsvall, 856 43
Uppsala Academic Hospital
Uppsala, 751 85
About this study
Official title: Can Gastropexy Improve the Efficacy of the Crural Repair in Patients With Paraesophageal Hernias? A Double Blind, Randomized, Multicenter Clinical Trial
Patients scheduled for surgery for primary paraesophageal herniation are randomized to either conventional surgical hernia repair or with the addition of gastropexy.
Read the detailed description
Patients scheduled for surgery due to primary paraesophageal herniation are randomized into either the control group or the interventional group.
Control Group: Patients undergo a crural repair combined with a short and floppy Nissen fundoplication.
Interventional Group: In addition to the crural repair and Nissen fundoplication, patients receive a gastropexy. This involves the fixation of the posterior part of the wrap the right crus, the left portion of the wrap to the diaphragm, and the minor curvature of the stomach to the abdominal wall.
Follow-Up Assessments:
Imaging: Computed tomography (CT) scans are performed before surgery and at 1 and 3 years postoperatively to evaluate anatomical outcomes.
Patient-Reported Outcomes: The following questionnaires are completed before surgery, as well as at 3 months, 1 year, and 3 years after surgery:
SF-36: A global quality of life instrument. GSRS: The Gastrointestinal Symptoms Rating Scale. Reflux Frequency Questionnaire: A measure reflux disease-related symptoms. Dakkak's Dysphagia Score: An assessment of swallowing difficulties.
- Conditions
- Paraesophageal Hernia
- Being tested
- Gastropexy, Paraesophageal hernia repair
- Medical subject headings
- Hernia, Hiatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GastropexyProcedure or surgery
In the intervention group, a three-point gastropexy is added to the repair. First, the right fundus flap is adapted posteriorly to the crural portion of the diaphragm with a 2-3 cm long running non-absorbable suture ("posterior gastropexy"). Second, the left fundus flap is adapted to the diaphragm anterolateral to the hiatus with a 2-3 cm long running non-absorbable suture ("left anterolateral gastropexy"). Finally, the minor curvature of the anterior stomach wall is adapted during reduced intraabdominal pressure to the anterior abdominal wall with a 2-3 cm long running non-absorbable suture ("anterior gastropexy").
Paraesophageal hernia repairProcedure or surgery
Ultrasonic shears are used for dissection. The herniated viscera are completely reduced into the abdomen and the hernia sac in fully dissected and resected. The esophagus is mobilized intraabdominally until at least 3 cm rests below the hiatus without tension. The anterior and posterior vagal nerves are identified and preserved. A posterior crural closure with running non-absorbable sutures is performed. An additional anterior crural closure may be performed at the surgeon's discretion. The fundus is mobilized to allow a floppy fundoplication. A total fundoplication is created by three interrupted non-absorbable sutures. No bougies are used routinely for calibration of the fundoplication.
| Study group | Role | What they receive |
|---|---|---|
| Standard paraesophageal hernia repair | Active comparator | Standard paraesophageal hernia repair (crural suturing and a total (Nissen) fundoplication) Receives: Procedure: Paraesophageal hernia repair |
| Standard paraesophageal hernia repair + gastropexy | Experimental | Standard paraesophageal hernia repair with the addition of a three point gastropexy (posterior, left anterolateral and anterior gastropexy) Receives: Procedure: Gastropexy; Procedure: Paraesophageal hernia repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of hernia at 1 year after surgery
Computer tomography of abdomen and thorax
Measured: 1 year
Secondary outcomes (7)
Recurrence of hernia at 3 years after surgery
Computer tomography of abdomen and thorax
Measured: 3 year
Complications after surgery
Complication classified according to Clavien-Dindo
Measured: 30 days after surgery
Length of stay at the hospital after surgery
Information from patients journal
Measured: 30 days after surgery
Changes in the patients perception of quality of life after surgery
SF-36 (Short Form 36) is a health related quality of life questionnaire. SF-36 is comprised of 36 items that assess eight dimensions of health: 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. Higher scores mean a better outcome. These can be grouped into mental and physical component summary scores. Scoring is from 0-100. A mean score of 50 has been articulated as normative value.
Measured: 3 months, 12 months, and 36 months
Changes in the patients perception of gastrointestinal symptoms after surgery
GSRS (The Gastrointestinal Symptom Rating Scale) is a questionnaire, which contains 15 items, and uses a seven-graded Likert scale, where 1 represents the most positive option and 7 the most negative one. The questions are grouped in five dimensions. A mean value for the items in each dimension will 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: 3 months, 12 months, and 36 months
Changes in the patients perception of dysphagia after surgery
The Dakkak dysphagia score is a questionnaire for assessing benign dysphagia, including nine questions regarding the frequency (always, sometimes, or never) of swallowing difficulties with different food consistencies (liquid, semisolid, and solid foods). The final score ranges from 0 to 45, where 45 represents the most severe dysphagia.
Measured: 3 months, 12 months, and 36 months
Changes in the patients perception of dysphagia and reflux frequency after surgery
Symptoms of heartburn, reflux, chest pain, dysphagia for liquids and solids, dyspnea, coughing and odynophagia were recorded using a four-graded scale to assess the frequency of symptoms with an arbitrary (empirical) cut off for clinical significance. The same instrument has been used in a previous RCT, from the same institution, comparing different types of anti-reflux procedures.
Measured: 3 months, 12 months, and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start1 Jun 2023
- Primary completion31 Oct 2027 (estimated)
- Study completion30 Nov 2029 (estimated)
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.
- 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
- Conventional paraesophageal hernia repair with the addition of gastropexy
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ersta Diakoni
- Sponsor type
- University, hospital or other
- Collaborators
- Göteborg University, Sundsvall Hospital, Karolinska Institutet
- Responsible party
- Principal investigator, Marcus Reuterwall Hansson, Ersta Diakoni
- Investigators
- Anders Thorell, Professor, Study director, Ersta Diakoni
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06107634
- Sponsor's protocol ID
- Dnr 2023-01956-01
- Acronym
- PEH3
- Status last verified
- Oct 2026
- First submitted
- 19 Sep 2023
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dackhammar JB, Tsoposidis A, Wallenius V, Kostic S, Cengiz Y, Linder G, Jeremiasen M, Analatos A, Lundell L, Hakanson B, Thorell A, Hansson MR. Can gastropexy reduce the recurrence rate after paraesophageal hernia repair? A study protocol for a double blind, randomized, multicenter clinical trial. Trials. 2026 Mar 16;27(1):281. doi: 10.1186/s13063-026-09578-7.
PubMed 41840686
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Gastropexy Improve the Efficacy of the Crural Repair in Patients With Paraesophageal Hernias? A Double Blind, Randomized, Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT06107634
- Acronym / sponsor ID
- PEH3 / Dnr 2023-01956-01
- Conditions
- Paraesophageal Hernia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Ersta DiakoniUniversity, hospital or other
- Collaborators
- Göteborg University, Sundsvall Hospital, Karolinska Institutet
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 30 Nov 2029 (estimated)
- First posted
- 30 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients scheduled for surgery for primary paraesophageal herniation are randomized to either conventional surgical hernia repair or with the addition of gastropexy.
Detailed description
Patients scheduled for surgery due to primary paraesophageal herniation are randomized into either the control group or the interventional group.
Control Group: Patients undergo a crural repair combined with a short and floppy Nissen fundoplication.
Interventional Group: In addition to the crural repair and Nissen fundoplication, patients receive a gastropexy. This involves the fixation of the posterior part of the wrap the right crus, the left portion of the wrap to the diaphragm, and the minor curvature of the stomach to the abdominal wall.
Follow-Up Assessments:
Imaging: Computed tomography (CT) scans are performed before surgery and at 1 and 3 years postoperatively to evaluate anatomical outcomes.
Patient-Reported Outcomes: The following questionnaires are completed before surgery, as well as at 3 months, 1 year, and 3 years after surgery:
SF-36: A global quality of life instrument. GSRS: The Gastrointestinal Symptoms Rating Scale. Reflux Frequency Questionnaire: A measure reflux disease-related symptoms. Dakkak's Dysphagia Score: An assessment of swallowing difficulties.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Conventional paraesophageal hernia repair with the addition of gastropexy
| Arm | Type | Receives |
|---|---|---|
| Standard paraesophageal hernia repair | Active comparator | Procedure: Paraesophageal hernia repairStandard paraesophageal hernia repair (crural suturing and a total (Nissen) fundoplication) |
| Standard paraesophageal hernia repair + gastropexy | Experimental | Procedure: Gastropexy, Procedure: Paraesophageal hernia repairStandard paraesophageal hernia repair with the addition of a three point gastropexy (posterior, left anterolateral and anterior gastropexy) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed with a primary paraesophageal hernia (hiatal hernia types II-IV) who are scheduled for elective or emergency surgical repair at participating centers
Key exclusion criteria (4 listed)
- Previous major upper gastrointestinal (GI) surgery, including prior hiatal hernia repair.
- Diagnosis of achalasia or any other significant esophageal motility disorder.
- Inability to understand the purpose of the study and/or inability or unwillingness to provide informed consent.
- Severe comorbidities, defined by an American Society of Anesthesiologists (ASA) physical status score of greater than III.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GastropexyIn the intervention group, a three-point gastropexy is added to the repair. First, the right fundus flap is adapted posteriorly to the crural portion of the diaphragm with a 2-3 cm long running non-absorbable suture ("posterior gastropexy"). Second, the left fundus flap is adapted to the diaphragm anterolateral to the hiatus with a 2-3 cm long running non-absorbable suture ("left anterolateral gastropexy"). Finally, the minor curvature of the anterior stomach wall is adapted during reduced intraabdominal pressure to the anterior abdominal wall with a 2-3 cm long running non-absorbable suture ("anterior gastropexy"). | Procedure or surgery | Standard paraesophageal hernia repair + gastropexy |
| Paraesophageal hernia repairUltrasonic shears are used for dissection. The herniated viscera are completely reduced into the abdomen and the hernia sac in fully dissected and resected. The esophagus is mobilized intraabdominally until at least 3 cm rests below the hiatus without tension. The anterior and posterior vagal nerves are identified and preserved. A posterior crural closure with running non-absorbable sutures is performed. An additional anterior crural closure may be performed at the surgeon's discretion. The fundus is mobilized to allow a floppy fundoplication. A total fundoplication is created by three interrupted non-absorbable sutures. No bougies are used routinely for calibration of the fundoplication. | Procedure or surgery | Standard paraesophageal hernia repair, Standard paraesophageal hernia repair + gastropexy |
Primary outcome
Recurrence of hernia at 1 year after surgery
Time frame: 1 year
Computer tomography of abdomen and thorax
7 secondary outcomes
Recurrence of hernia at 3 years after surgery
Time frame: 3 year
Complications after surgery
Time frame: 30 days after surgery
Length of stay at the hospital after surgery
Time frame: 30 days after surgery
Changes in the patients perception of quality of life after surgery
Time frame: 3 months, 12 months, and 36 months
Changes in the patients perception of gastrointestinal symptoms after surgery
Time frame: 3 months, 12 months, and 36 months
Changes in the patients perception of dysphagia after surgery
Time frame: 3 months, 12 months, and 36 months
Changes in the patients perception of dysphagia and reflux frequency after surgery
Time frame: 3 months, 12 months, and 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Derived from this study: PubMed 41840686Dackhammar JB, Tsoposidis A, Wallenius V, Kostic S, Cengiz Y, Linder G, Jeremiasen M, Analatos A, Lundell L, Hakanson B, Thorell A, Hansson MR. Can gastropexy reduce the recurrence rate after paraesophageal hernia repair? A study protocol for a double blind, randomized, multicenter clinical trial. Trials. 2026 Mar 16;27(1):281. doi: 10.1186/s13063-026-09578-7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anders Thorell, Professor study director
Ersta Diakoni
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gastropexy and Paraesophageal hernia repair in people with Paraesophageal Hernia, run by Ersta Diakoni at 6 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of hernia at 1 year after surgery (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06107634, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.