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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03025932
Other study ID # 2016-01510
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
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Completed NCT04007952 - Anterior Gastropexy vs. No Anterior Gastropexy for Paraesophageal Hernia Repair N/A
Recruiting NCT04695171 - LINX Reflux Management System or Fundoplication Clinical Study in Patients With Hiatal Hernia >3 cm