Recurrence Rate After Laparoscopic Repair of Large Hiatal Hernia

NCT03025932 | Enrolling By Invitation

• 1 other identifier: 2016-01510
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hiatal Hernia Large

Outcome Measures

Primary Outcomes (1)

• 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

  minimum 1 year after surgery

Secondary Outcomes (3)

• Quality of life by GIQLI

  minimum 1 year after surgery

• Clinical outcome

  minimum 1 year after surgery

• Peri- and postoperative morbidity / mortality

  minimum 1 year after surgery

Study Arms (1)

Patient cohort

Patients who underwent laparoscopic hernia repair of giant hiatal hernia with mesh and received anterior fundoplication

Procedure: repair of giant hiatal hernia with mesh and anterior fundoplication

Interventions

repair of giant hiatal hernia with mesh and anterior fundoplication PROCEDURE

Patient cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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

You may qualify if:

• 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)

You may not qualify if:

• Performance of any other anti-reflux surgery such as Toupet- or Nissen-fundoplication
• Performance of anterior fundoplication without mesh

Sponsors & Collaborators

• Prof Urs Zingg: lead

Related Publications (1)

• 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 DERIVED

MeSH Terms

Interventions

Melanocyte-Stimulating Hormones

Intervention Hierarchy (Ancestors)

Melanocortins; Pro-Opiomelanocortin; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Urs Zingg

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PD Dr. med.

Study Record Dates

• First Submitted: January 9, 2017
• First Posted: January 20, 2017
• Study Start: January 1, 2016
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share