Recurrence Rate After Laparoscopic Repair of Large Hiatal Hernia

Hiatal Hernia Large Clinical Trial

Official title:

Clinical vs. Radiological Recurrence Rate After Laparoscopic Repair of Large Hiatal Hernia With Mesh and Anterior Fundoplication

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03025932
• Other study ID #: 2016-01510
• Status: Enrolling by invitation
• Start date: January 2016
• Est. completion date: January 31, 2027

Study information

• Verified date: November 2023
• Source: Spital Limmattal Schlieren
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: January 31, 2027
• Est. primary completion date: January 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Hiatal
• Hiatal Hernia Large
• Recurrence

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Prof Urs Zingg

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	minimum 1 year after surgery
Secondary	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.	minimum 1 year after surgery
Secondary	Peri- and postoperative morbidity / mortality	Evaluate the peri- and postoperative morbidity and mortality from the patient records and a clinical examination	minimum 1 year after surgery