Recurrence Rate After Laparoscopic Repair of Large Hiatal Hernia

November 23, 2023 updated by: Prof Urs Zingg

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

Patients who underwent laparoscopic repair of large hiatal hernias and anterior fundoplication with mesh are examined for their recurrence rate one year after surgery.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
minimum 1 year after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
minimum 1 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.
minimum 1 year after surgery
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
minimum 1 year after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof Urs Zingg

Investigators

  • Principal Investigator: Urs Zingg, Principal Investigator

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

January 9, 2017

First Submitted That Met QC Criteria

January 17, 2017

First Posted (Estimated)

January 20, 2017

Study Record Updates

Last Update Posted (Actual)

November 27, 2023

Last Update Submitted That Met QC Criteria

November 23, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-01510

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hiatal Hernia Large

Clinical Trials on repair of giant hiatal hernia with mesh and anterior fundoplication

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uzbekistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe