GERDNCT05069493
Long-term Follow-up After Hiatal Hernia Repair by Tension-free Mesh Closure or Simple Suturing
An observational study of GERD and Hiatal Hernia, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
10 years of follow-up after surgery for hiatal hernia by tension-free mesh closure or simple suturing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GERD, Hiatal Hernia, Dysphagia, Esophageal
- What is being tested?
- simple suturing and mesh
- Type of treatment
- Surgery or procedure
- How many people
- 103 participants
- Where
- 1 siteSweden
- Study dates
- 15 Sep 2021to 30 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients who were included in the previous study (hiatal hernia repair by tension-free mesh closure or simple suturing) and are available for inclusion at the long-term follow-up.
Who may be able to join
- -Patients available at the time of follow-up
Who cannot join
- Deceased
- Declined participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hiatal Hernia Repair by Tension-free Mesh Closure or Simple Suturing of the Diaphragmatic Hiatus. Long-term (>10 Years) Follow-up of a Randomized, Double-blind Clinical Trial
10 years of follow-up after surgery for hiatal hernia by tension-free mesh closure or simple suturing.
Read the detailed description
One-hundred and fifty-nine patients undergoing Nissen fundoplication for symptomatic gastro-oesophageal reflux disease (GORD), who had a concomitant hiatal hernia of > 2 cm axial length, were previously randomized to closure of the diaphragmatic hiatus with either crural sutures alone or tension-free closure with a non-absorbable mesh. Primary outcome variable was the incidence of radiologically verified recurrent hiatal hernia 3 years after the surgery and secondary outcomes were dysphagia score, reflux control and quality of life. The study showed no differences between the groups regarding hiatal hernia recurrence but higher dysphagia scores for solid food at 3 years in mesh group.
This study is a long-term follow-up (>10 years) after surgery for hiatal hernia by tension-free mesh closure or simple suturing.
- Conditions
- GERD, Hiatal Hernia, Dysphagia, Esophageal, Quality of Life
- Being tested
- simple suturing, mesh
- Medical subject headings
- Gastroesophageal Reflux, Hernia, Hiatal, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simple suturingProcedure or surgery
Hiatal hernia repair by simple suturing of the diaphragmatic
meshProcedure or surgery
Hiatal hernia repair by tension-free mesh closure
| Study group | Role | What they receive |
|---|---|---|
| Tension-free | Hiatal hernia repair by tension-free mesh closure Receives: Procedure: mesh | |
| Suturing | Hiatal hernia repair by simple suturing of the diaphragmatic Receives: Procedure: simple suturing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent hiatal hernia
The incidence of radiologically verified recurrent hiatal hernia
Measured: 10 years
Secondary outcomes (4)
Dysphagia
Dysphagia for liquids and solids were recorded within a four-graded scale stating the frequency of dysphagia episodes with an arbitrary (empirical) cut off for clinical significance. The same dysphagia scoring was also used in a previous rct, from the same institution, comparing different types of antireflux procedures in open surgery.
Measured: 10 years
Gastrointestinal symptom rating scale (GSRS)
A validated questionnaire containing five dimensions of abdominal symptoms (gastroesophageal reflux, abdominal pain, indigestion, obstipation and diarrhea
Measured: 10 years
Quality of Life, physical and mental score: SF-36
The Swedish version of the validated global Short Form -36 (SF-36) questionnaire was used and data are presented as physical and mental summary component scores (PCS and MCS, respectively)
Measured: 10 years
Proton pump inhibitor (PPI)
Number of patients who report daily intake of PPI at the time of the follow up Use of PPI use of PPI
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start15 Sep 2021
- Primary completion30 Mar 2022
- Study completion30 Jun 2022
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 GERDStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ersta Hospital, Sweden
- Responsible party
- Principal investigator, Lars Lundell, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05069493
- Sponsor's protocol ID
- PATCH2
- Status last verified
- Oct 2022
- First submitted
- 26 Sep 2021
- Last updated
- 18 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Analatos A, Hakanson BS, Ansorge C, Lindblad M, Lundell L, Thorell A. Hiatal Hernia Repair With Tension-Free Mesh or Crural Sutures Alone in Antireflux Surgery: A 13-Year Follow-Up of a Randomized Clinical Trial. JAMA Surg. 2024 Jan 1;159(1):11-18. doi: 10.1001/jamasurg.2023.4976.
PubMed 37819652
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hiatal Hernia Repair by Tension-free Mesh Closure or Simple Suturing of the Diaphragmatic Hiatus. Long-term (>10 Years) Follow-up of a Randomized, Double-blind Clinical Trial
- ClinicalTrials.gov ID
- NCT05069493
- Acronym / sponsor ID
- PATCH2
- Conditions
- GERD, Hiatal Hernia, Dysphagia, Esophageal, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Ersta Hospital, Sweden
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 6 Oct 2021 (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.
10 years of follow-up after surgery for hiatal hernia by tension-free mesh closure or simple suturing.
Detailed description
One-hundred and fifty-nine patients undergoing Nissen fundoplication for symptomatic gastro-oesophageal reflux disease (GORD), who had a concomitant hiatal hernia of > 2 cm axial length, were previously randomized to closure of the diaphragmatic hiatus with either crural sutures alone or tension-free closure with a non-absorbable mesh. Primary outcome variable was the incidence of radiologically verified recurrent hiatal hernia 3 years after the surgery and secondary outcomes were dysphagia score, reflux control and quality of life. The study showed no differences between the groups regarding hiatal hernia recurrence but higher dysphagia scores for solid food at 3 years in mesh group.
This study is a long-term follow-up (>10 years) after surgery for hiatal hernia by tension-free mesh closure or simple suturing.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tension-free | – | Procedure: meshHiatal hernia repair by tension-free mesh closure |
| Suturing | – | Procedure: simple suturingHiatal hernia repair by simple suturing of the diaphragmatic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who were included in the previous study (hiatal hernia repair by tension-free mesh closure or simple suturing) and are available for inclusion at the long-term follow-up.
Key inclusion criteria (1 listed)
- -Patients available at the time of follow-up
Key exclusion criteria (2 listed)
- Deceased
- Declined participation
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 |
|---|---|---|
| simple suturingHiatal hernia repair by simple suturing of the diaphragmatic | Procedure or surgery | Suturing |
| meshHiatal hernia repair by tension-free mesh closure | Procedure or surgery | Tension-free |
Primary outcome
Recurrent hiatal hernia
Time frame: 10 years
The incidence of radiologically verified recurrent hiatal hernia
4 secondary outcomes
Dysphagia
Time frame: 10 years
Gastrointestinal symptom rating scale (GSRS)
Time frame: 10 years
Quality of Life, physical and mental score: SF-36
Time frame: 10 years
Proton pump inhibitor (PPI)
Time frame: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
- Derived from this study: PubMed 37819652Analatos A, Hakanson BS, Ansorge C, Lindblad M, Lundell L, Thorell A. Hiatal Hernia Repair With Tension-Free Mesh or Crural Sutures Alone in Antireflux Surgery: A 13-Year Follow-Up of a Randomized Clinical Trial. JAMA Surg. 2024 Jan 1;159(1):11-18. doi: 10.1001/jamasurg.2023.4976.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of GERD and Hiatal Hernia, run by Karolinska University Hospital at 1 site 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 2 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: finished, as of the sponsor's last update on 18 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Recurrent hiatal hernia (time frame: 10 years). 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 NCT05069493, 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 18 Oct 2022.