Paraesophageal HerniaNCT06096402
Gastropexy as a Treatment Option for Paraesophageal Hernia
An observational study of Paraesophageal Hernia, run by University Hospital of North Norway at 3 sites in 2 countries.
Trial summary
The present proposal aims to asses which is the optimal treatment strategy in a clinical study in patients with paraoesophageal hernia (PEH), a condition often found in elderly, fragile patients The investigator want to study the optimal approach to a paraoesophageal hernia (PEH) repair. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paraesophageal Hernia
- Type of treatment
- Surgery or procedure
- How many people
- 220 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Jun 2024to 31 Dec 2027
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Adults with a paraesophageal hernia with indication of operation
Who may be able to join
- Both emergent and elective repair of the paraoesophageal hernia
Who cannot join
- -
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
Norway2 sites
University Hospital of North Norway
Harstad
Lene Osterballe, MD
St Olavs Hospital
Trondheim
Per Even Storli, MD
About this study
Official title: Selective Anterior Gastropexy as a Surgical Treatment Option for Paraesophageal Hernia
The present proposal aims to asses which is the optimal treatment strategy in a clinical study in patients with paraoesophageal hernia (PEH), a condition often found in elderly, fragile patients The investigator want to study the optimal approach to a paraoesophageal hernia (PEH) repair. The incidence of PEH increases with age and the older patient typically has additional co-morbidities, reduced physiological fitness, and frailty which makes surgery challenging regarding increased morbidity and mortality. Thus, the decision to offer surgery can be challenging in this cohort of patients. The need of an anti-reflux procedure as part of the repair is one of the main subjects for discussion worldwide. To date no consensus exists and many surgical centres do a routine anti-reflux procedure as part of their standard operation for PEH. But is this procedure redundant? Can the patients be managed with a less complicated procedure; an anterior gastropexy with comparable outcome?
Read the detailed description
A hiatal hernia is a widening of the diaphragmatic hiatus causing herniation of the stomach into the thoracic cavity. It develops because of an insufficiency of the hiatus. The paraesophageal hernias (PEH) are classified as grade II-IV hiatal hernia with at least 50 % of the stomach misplaced in the thoracic cavity.
A paraesophageal hernia (PEH) is a potentially dangerous condition. One see in varied degree, the stomach and other organs being misplaced above diaphragm, in the thoracic cavity. Symptoms such as dysphagia, vomitus, weight loss, pain, short breath and emergent situations where abdominal organs are strangulated with risk of tissue death in thorax defines whether a patient should be offered operation and how fast it should be performed.
The operative management of PEH has become a laparoscopic procedure within the last 20-30 years with a concomitant significant decrease in morbidity and length of hospital stay. It is managed by different subspecialized surgeons, all of them having different perspectives and approaches to this condition. Surgery in this area is potentially high-risk operations with risk of perforation of oesophagus, injury to lungs, aorta, pericardia, spleen and stomach. Without operation symptomatic patients with PEH are at risk of developing an acute surgical condition with organ perforation with high per-and postoperative mortality.
Contemporary surgical technique is divided into three crucial steps; 1) removal of the hernia sac, 2) hiatoplasty with or without mesh and 3) an anti-reflux procedure and/or gastropexy. Each step is managed differently among surgeons/centres worldwide with varying evidence. Many surgeons add an anti-reflux procedure to the surgical management of PEH, to protect against postoperative acid reflux. The argument is that an anti-reflux procedure lowers postoperative reflux and recurrence of the paraesophageal hernia, but this is without clear evidence. As an addition or an alternative in step three of the PEH procedure, some centres do an anterior gastropexy to anchor the stomach in the abdominal cavity. It is a simple technique compared with an anti-reflux procedure with possibly equal satisfactory long-term outcomes but less postoperative complications. However, evidence is sparse and larger studies on this technique are highly warranted.
The aim is to study the need of a fundoplication as part of the procedure for PEH regarding symptom control and quality of life. For this reason, The investigator want to set up a prospective two-armed multicenter study in collaboration with St. Olav's Hospital, Trondheim and Gastroenheden, Hvidovre, Denmark. The reason for this collaboration is 1) to enlarge the group of investigation, as PEH is a rare condition, 2) to compare current practice (fundoplication/no fundoplication) among the included institutions. .
- Conditions
- Paraesophageal Hernia
- Being tested
- no intervention, but surgical practice as usual is continued. Its a pragmatic study
- Keywords
- paraesophageal hernia, gastropexy, fundoplication
- Medical subject headings
- Hernia, Hiatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no intervention, but surgical practice as usual is continued. Its a pragmatic studyProcedure or surgery
no intervention
| Study group | Role | What they receive |
|---|---|---|
| anterior gastropexy, no fundoplication | patients with indication of operative management of a paraesophageal hernia Receives: Procedure: no intervention, but surgical practice as usual is continued. Its a pragmatic study | |
| anterior gastropexy and fundoplication | patients with indication of operative management of a paraesophageal hernia Receives: Procedure: no intervention, but surgical practice as usual is continued. Its a pragmatic study |
What is being measured
The primary outcome is the main question the study is designed to answer.
peri- and postoperative complications
according to clavien-dindo score
Measured: 30 days after operation
Gastro-esophageal reflux disease-Health related quality of life, GERD-HRQL
The GERD-HRQL questionnaire evaluates heartburn, dysphagia and regurgitation on a scale from zero (no symptoms) to five (severe symptoms) in 15 questions. Maximum score ranges from zero to 75 points
Measured: Before surgery and 3,6 and 12 months after surgery
Short From questionnaire (SF-36) Health related quality of life
SF-36 is a well-established questionnaire consisting of 36 health related questions. Scale is from 0-100 for each section (8 sections) A high score corresponds to a better health status
Measured: before surgery and 3, 6 and 12 months after surgery
Secondary outcomes (1)
Total number of patients with radiological recurrence after one year
esophagus x-ray/barium swallow one year after surgery
Measured: one year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start1 Jun 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- Hvidovre University Hospital, St. Olavs Hospital
- Responsible party
- Principal investigator, Kim Erlend Mortensen, University Hospital of North Norway
- Investigators
- Kim Erlend Mortensen, MD, PhD, Study director, University of North Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06096402
- Sponsor's protocol ID
- 625668 (REK)
- Status last verified
- Oct 2023
- First submitted
- 19 Sep 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Anterior Gastropexy as a Surgical Treatment Option for Paraesophageal Hernia
- ClinicalTrials.gov ID
- NCT06096402
- Acronym / sponsor ID
- 625668 (REK)
- Conditions
- Paraesophageal Hernia
- Keywords
- paraesophageal hernia, gastropexy, fundoplication
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- Hvidovre University Hospital, St. Olavs Hospital
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 23 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.
The present proposal aims to asses which is the optimal treatment strategy in a clinical study in patients with paraoesophageal hernia (PEH), a condition often found in elderly, fragile patients The investigator want to study the optimal approach to a paraoesophageal hernia (PEH) repair. The incidence of PEH increases with age and the older patient typically has additional co-morbidities, reduced physiological fitness, and frailty which makes surgery challenging regarding increased morbidity and mortality. Thus, the decision to offer surgery can be challenging in this cohort of patients. The need of an anti-reflux procedure as part of the repair is one of the main subjects for discussion worldwide. To date no consensus exists and many surgical centres do a routine anti-reflux procedure as part of their standard operation for PEH. But is this procedure redundant? Can the patients be managed with a less complicated procedure; an anterior gastropexy with comparable outcome?
Detailed description
A hiatal hernia is a widening of the diaphragmatic hiatus causing herniation of the stomach into the thoracic cavity. It develops because of an insufficiency of the hiatus. The paraesophageal hernias (PEH) are classified as grade II-IV hiatal hernia with at least 50 % of the stomach misplaced in the thoracic cavity.
A paraesophageal hernia (PEH) is a potentially dangerous condition. One see in varied degree, the stomach and other organs being misplaced above diaphragm, in the thoracic cavity. Symptoms such as dysphagia, vomitus, weight loss, pain, short breath and emergent situations where abdominal organs are strangulated with risk of tissue death in thorax defines whether a patient should be offered operation and how fast it should be performed.
The operative management of PEH has become a laparoscopic procedure within the last 20-30 years with a concomitant significant decrease in morbidity and length of hospital stay. It is managed by different subspecialized surgeons, all of them having different perspectives and approaches to this condition. Surgery in this area is potentially high-risk operations with risk of perforation of oesophagus, injury to lungs, aorta, pericardia, spleen and stomach. Without operation symptomatic patients with PEH are at risk of developing an acute surgical condition with organ perforation with high per-and postoperative mortality.
Contemporary surgical technique is divided into three crucial steps; 1) removal of the hernia sac, 2) hiatoplasty with or without mesh and 3) an anti-reflux procedure and/or gastropexy. Each step is managed differently among surgeons/centres worldwide with varying evidence. Many surgeons add an anti-reflux procedure to the surgical management of PEH, to protect against postoperative acid reflux. The argument is that an anti-reflux procedure lowers postoperative reflux and recurrence of the paraesophageal hernia, but this is without clear evidence. As an addition or an alternative in step three of the PEH procedure, some centres do an anterior gastropexy to anchor the stomach in the abdominal cavity. It is a simple technique compared with an anti-reflux procedure with possibly equal satisfactory long-term outcomes but less postoperative complications. However, evidence is sparse and larger studies on this technique are highly warranted.
The aim is to study the need of a fundoplication as part of the procedure for PEH regarding symptom control and quality of life. For this reason, The investigator want to set up a prospective two-armed multicenter study in collaboration with St. Olav's Hospital, Trondheim and Gastroenheden, Hvidovre, Denmark. The reason for this collaboration is 1) to enlarge the group of investigation, as PEH is a rare condition, 2) to compare current practice (fundoplication/no fundoplication) among the included institutions. .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| anterior gastropexy, no fundoplication | – | Procedure: no intervention, but surgical practice as usual is continued. Its a pragmatic studypatients with indication of operative management of a paraesophageal hernia |
| anterior gastropexy and fundoplication | – | Procedure: no intervention, but surgical practice as usual is continued. Its a pragmatic studypatients with indication of operative management of a paraesophageal hernia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adults with a paraesophageal hernia with indication of operation
Key inclusion criteria (1 listed)
- Both emergent and elective repair of the paraoesophageal hernia
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| no intervention, but surgical practice as usual is continued. Its a pragmatic studyno intervention | Procedure or surgery | anterior gastropexy and fundoplication, anterior gastropexy, no fundoplication |
Primary outcome
peri- and postoperative complications
Time frame: 30 days after operation
according to clavien-dindo score
Gastro-esophageal reflux disease-Health related quality of life, GERD-HRQL
Time frame: Before surgery and 3,6 and 12 months after surgery
The GERD-HRQL questionnaire evaluates heartburn, dysphagia and regurgitation on a scale from zero (no symptoms) to five (severe symptoms) in 15 questions. Maximum score ranges from zero to 75 points
Short From questionnaire (SF-36) Health related quality of life
Time frame: before surgery and 3, 6 and 12 months after surgery
SF-36 is a well-established questionnaire consisting of 36 health related questions. Scale is from 0-100 for each section (8 sections) A high score corresponds to a better health status
1 secondary outcome
Total number of patients with radiological recurrence after one year
Time frame: one year after surgery
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 23 Oct 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Paraesophageal Hernia
Active, not recruiting
Gastropexy in the Repair of Patients With Paraesophageal Hernias
Paraesophageal Hernia
Recruiting
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Paraesophageal Hernia, GERD
Recruiting
Impact of Biosynthetic Mesh on Paraesophageal Hernia Repair
Hiatal Hernia
Not yet recruiting
Antireflux Surgery Without Preoperative Esophageal Manometry
GERD, Hiatal Hernia
Recruiting
Laparoscopic Nissen Versus Toupet Fundoplication for Hiatal Hernia.
Hiatal Hernia, Paraesophageal, Hiatal Hernia Large
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.
Kim Erlend Mortensen, MD, PhD study director
University of North Norway
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Paraesophageal Hernia, run by University Hospital of North Norway at 3 sites in 2 countries.
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 1 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: opening soon, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Norway, Denmark. 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?
Contact Lene Osterballe, MD (+4797572401, lene.osterballe@unn.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
peri- and postoperative complications (time frame: 30 days after operation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Oct 2023.