Hiatal Hernia LargeNCT03025932
Recurrence Rate After Laparoscopic Repair of Large Hiatal Hernia
An observational study of Hiatal Hernia Large, run by Prof Urs Zingg.
Trial summary
Patients who underwent laparoscopic repair of large hiatal hernias and anterior fundoplication with mesh are examined for their recurrence rate one year after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hiatal Hernia Large
- What is being tested?
- repair of giant hiatal hernia with mesh and anterior fundoplication
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to 31 Jan 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
- No healthy volunteers
- Adult, Older adult
Study population: Inclusion of all patients older than 18 years with initial large hiatal hernia (>20% herniated into thoracic cavity) and laparoscopic hiatoplasty with mesh and anterior fundoplication
Who may be able to join
- Age older than 18 years
- Initially suffering from large hiatal hernia (>20% of the stomach in the thoracic cavity)
- Performance of laparoscopic hiatal hernia repair with mesh and anterior fundoplication
- Informed Consent as documented by signature (Appendix: Informed Consent Form)
Who cannot join
- Performance of any other anti-reflux surgery such as Toupet- or Nissen-fundoplication
- Performance of anterior fundoplication without mesh
- Women who meet the inclusion criteria but are pregnant or breast feeding or have the intention to become pregnant during the course of the study
About this study
Official title: Clinical vs. Radiological Recurrence Rate After Laparoscopic Repair of Large Hiatal Hernia With Mesh and Anterior Fundoplication
Patients who underwent laparoscopic repair of large hiatal hernias and anterior fundoplication with mesh are examined for their recurrence rate one year after surgery.
- Conditions
- Hiatal Hernia Large
- Being tested
- repair of giant hiatal hernia with mesh and anterior fundoplication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repair of giant hiatal hernia with mesh and anterior fundoplicationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Patient cohort | Patients who underwent laparoscopic hernia repair of giant hiatal hernia with mesh and received anterior fundoplication Receives: Procedure: repair of giant hiatal hernia with mesh and anterior fundoplication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological recurrence rate of hiatal hernia determined by computer tomography (CT) scan
To evaluate the radiological recurrence rate of hiatal hernia at least one year after surgery by performing a computer tomography
Measured: minimum 1 year after surgery
Secondary outcomes (3)
Quality of life by GIQLI
Estimate the quality of life using a standardized questionnaire (Gastrointestinal Qualitiy of Life Index = GIQLI) at least one year after surgery
Measured: minimum 1 year after surgery
Clinical outcome
Evaluate the clinical outcome at least one year after surgery by examining the patient and asking targeted questions on the symptoms regarding the former hiatal hernia (using visual analogue scale questions on dysphagia, meteorism, bloating, reflux and retrosternal pain). Furthermore the patients are asked about their general satisfaction regarding the performed surgical intervention.
Measured: minimum 1 year after surgery
Peri- and postoperative morbidity / mortality
Evaluate the peri- and postoperative morbidity and mortality from the patient records and a clinical examination
Measured: minimum 1 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 posted20 Jan 2017 (estimated)
- Study startJan 2016
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (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 Hiatal Hernia LargeStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof Urs Zingg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof Urs Zingg, Spital Limmattal Schlieren
- Investigators
- Urs Zingg, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03025932
- Sponsor's protocol ID
- 2016-01510
- Other IDs
- 2016
- Status last verified
- Jun 2026
- First submitted
- 9 Jan 2017
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Susstrunk J, Stimpfle D, Wilhelm A, Ghielmini EM, Potthast S, Zingg U. Clinical and computed tomography outcomes after mesh-enforced hiatoplasty and anterior hemi-fundoplication in large hiatal hernia repair. World J Surg. 2024 Nov;48(11):2669-2677. doi: 10.1002/wjs.12354. Epub 2024 Sep 20.
PubMed 39304965
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical vs. Radiological Recurrence Rate After Laparoscopic Repair of Large Hiatal Hernia With Mesh and Anterior Fundoplication
- ClinicalTrials.gov ID
- NCT03025932
- Acronym / sponsor ID
- 2016-01510
- Conditions
- Hiatal Hernia Large
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Prof Urs ZinggUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 20 Jan 2017 (estimated)
- 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 who underwent laparoscopic repair of large hiatal hernias and anterior fundoplication with mesh are examined for their recurrence rate one year after surgery.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient cohort | – | Procedure: repair of giant hiatal hernia with mesh and anterior fundoplicationPatients who underwent laparoscopic hernia repair of giant hiatal hernia with mesh and received anterior fundoplication |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inclusion of all patients older than 18 years with initial large hiatal hernia (>20% herniated into thoracic cavity) and laparoscopic hiatoplasty with mesh and anterior fundoplication
Key inclusion criteria (4 listed)
- Age older than 18 years
- Initially suffering from large hiatal hernia (>20% of the stomach in the thoracic cavity)
- Performance of laparoscopic hiatal hernia repair with mesh and anterior fundoplication
- Informed Consent as documented by signature (Appendix: Informed Consent Form)
Key exclusion criteria (3 listed)
- Performance of any other anti-reflux surgery such as Toupet- or Nissen-fundoplication
- Performance of anterior fundoplication without mesh
- Women who meet the inclusion criteria but are pregnant or breast feeding or have the intention to become pregnant during the course of the study
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 |
|---|---|---|
| repair of giant hiatal hernia with mesh and anterior fundoplication | Procedure or surgery | Patient cohort |
Primary outcome
Radiological recurrence rate of hiatal hernia determined by computer tomography (CT) scan
Time frame: minimum 1 year after surgery
To evaluate the radiological recurrence rate of hiatal hernia at least one year after surgery by performing a computer tomography
3 secondary outcomes
Quality of life by GIQLI
Time frame: minimum 1 year after surgery
Clinical outcome
Time frame: minimum 1 year after surgery
Peri- and postoperative morbidity / mortality
Time frame: minimum 1 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 9 Jun 2026.
- Derived from this study: PubMed 39304965Susstrunk J, Stimpfle D, Wilhelm A, Ghielmini EM, Potthast S, Zingg U. Clinical and computed tomography outcomes after mesh-enforced hiatoplasty and anterior hemi-fundoplication in large hiatal hernia repair. World J Surg. 2024 Nov;48(11):2669-2677. doi: 10.1002/wjs.12354. Epub 2024 Sep 20.
- 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.
Urs Zingg principal investigator
Principal Investigator
Questions about this trial
What is this clinical trial studying?
An observational study of Hiatal Hernia Large, run by Prof Urs Zingg.
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 4 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Radiological recurrence rate of hiatal hernia determined by computer tomography (CT) scan (time frame: minimum 1 year after surgery). 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 NCT03025932, 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 9 Jun 2026.