Recurrence Rate After Laparoscopic Repair of Large Hiatal Hernia

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

Tracking Information

• First Submitted Date: January 9, 2017
• First Posted Date: January 20, 2017
• Last Update Posted Date: November 27, 2023
• Study Start Date: January 2016
• Estimated Primary Completion Date: January 31, 2027 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 17, 2017)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 3, 2020)

• 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
• 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.
• 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

Original Secondary Outcome Measures (submitted: January 17, 2017)

• Quality of life [ 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
• 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.
• 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

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Recurrence Rate After Laparoscopic Repair of Large Hiatal Hernia
• Official Title: Clinical vs. Radiological Recurrence Rate After Laparoscopic Repair of Large Hiatal Hernia With Mesh and Anterior Fundoplication
• 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.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Case-Only; Time Perspective: Retrospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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
• Condition: Hiatal Hernia Large
• Intervention: Procedure: repair of giant hiatal hernia with mesh and anterior fundoplication

Study Groups/Cohorts

Patient cohort

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

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Enrolling by invitation
• Estimated Enrollment (submitted: September 21, 2021): 200
• Original Actual Enrollment (submitted: January 17, 2017): 50
• Estimated Study Completion Date: January 31, 2027
• Estimated Primary Completion Date: January 31, 2027 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT03025932
• Other Study ID Numbers: 2016-01510
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Prof Urs Zingg, Spital Limmattal Schlieren
• Original Responsible Party: PD Dr. Urs Zingg, Spital Limmattal Schlieren, PD Dr. med.
• Current Study Sponsor: Prof Urs Zingg
• Original Study Sponsor: PD Dr. Urs Zingg
• Collaborators: Not Provided

Investigators

• Principal Investigator: Urs Zingg; Principal Investigator

• PRS Account: Spital Limmattal Schlieren
• Verification Date: November 2023