Enrolling by invitation NCT03025932
Recurrence Rate After Laparoscopic Repair of Large Hiatal Hernia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: repair of giant hiatal hernia with mesh and anterior fundoplication.
- Who it may be relevant to
- Registry conditions: Hiatal Hernia Large. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical vs. Radiological Recurrence Rate After Laparoscopic Repair of Large Hiatal Hernia With Mesh and Anterior Fundoplication
Overview
Patients who underwent laparoscopic repair of large hiatal hernias and anterior fundoplication with mesh are examined for their recurrence rate one year after surgery.
Interventions
- Procedure repair of giant hiatal hernia with mesh and anterior fundoplication
Primary outcome measures
- Radiological recurrence rate of hiatal hernia determined by computer tomography (CT) scan [Time frame: minimum 1 year after surgery]
Secondary outcome measures (3)
- 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]
Eligibility criteria
Inclusion criteria
- 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)
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Center list to be confirmed — check the primary protocol.
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. PMID 39304965
Identifiers
NCT: NCT03025932 · 2016-01510