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Recurrence Rate After Laparoscopic Repair of Large Hiatal Hernia

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ClinicalTrials.gov Identifier: NCT03025932
Recruitment Status : Enrolling by invitation
First Posted : January 20, 2017
Last Update Posted : November 27, 2023
Sponsor:
Information provided by (Responsible Party):
Prof Urs Zingg, Spital Limmattal Schlieren

Study Description
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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.

Condition or disease Intervention/treatment
Hiatal Hernia Large Procedure: repair of giant hiatal hernia with mesh and anterior fundoplication

Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Clinical vs. Radiological Recurrence Rate After Laparoscopic Repair of Large Hiatal Hernia With Mesh and Anterior Fundoplication
Study Start Date : January 2016
Estimated Primary Completion Date : January 31, 2027
Estimated Study Completion Date : January 31, 2027

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Groups and Cohorts
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Group/Cohort Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Quality of life by GIQLI [ Time Frame: minimum 1 year after surgery ]
    Estimate the quality of life using a standardized questionnaire (Gastrointestinal Qualitiy of Life Index = GIQLI) at least one year after surgery

  2. Clinical outcome [ Time Frame: minimum 1 year after surgery ]
    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.

  3. Peri- and postoperative morbidity / mortality [ Time Frame: minimum 1 year after surgery ]
    Evaluate the peri- and postoperative morbidity and mortality from the patient records and a clinical examination


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03025932


Sponsors and Collaborators
Prof Urs Zingg
Investigators
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Principal Investigator: Urs Zingg Principal Investigator
More Information
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Responsible Party: Prof Urs Zingg, PD Dr. med., Spital Limmattal Schlieren
ClinicalTrials.gov Identifier: NCT03025932    
Other Study ID Numbers: 2016-01510
First Posted: January 20, 2017    Key Record Dates
Last Update Posted: November 27, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Hernia
Recurrence
Hernia, Hiatal
Pathological Conditions, Anatomical
 Disease Attributes
Pathologic Processes
Hernia, Diaphragmatic
Internal Hernia