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Completed

NCT Number: NCT05069493

Long-term Follow-up After Hiatal Hernia Repair by Tension-free Mesh Closure or Simple Suturing

10 years of follow-up after surgery for hiatal hernia by tension-free mesh closure or simple suturing.

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Key information

Conditions

GERD Deglutition Disorders Digestive System Diseases Dysphagia, Esophageal Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Hernia Hernia, Diaphragmatic Hernia, Hiatal Hiatal Hernia Internal Hernia Otorhinolaryngologic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Quality of Life

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ersta Hospital

Stockholm, Sweden

About this study

One-hundred and fifty-nine patients undergoing Nissen fundoplication for symptomatic gastro-oesophageal reflux disease (GORD), who had a concomitant hiatal hernia of > 2 cm axial length, were previously randomized to closure of the diaphragmatic hiatus with either crural sutures alone or tension-free closure with a non-absorbable mesh. Primary outcome variable was the incidence of radiologically verified recurrent hiatal hernia 3 years after the surgery and secondary outcomes were dysphagia score, reflux control and quality of life. The study showed no differences between the groups regarding hiatal hernia recurrence but higher dysphagia scores for solid food at 3 years in mesh group.

This study is a long-term follow-up (>10 years) after surgery for hiatal hernia by tension-free mesh closure or simple suturing.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-Patients available at the time of follow-up

Exclusion criteria

  • Deceased
  • Declined participation

Treatment and study plan

simple suturing

Procedure

Hiatal hernia repair by simple suturing of the diaphragmatic

mesh

Procedure

Hiatal hernia repair by tension-free mesh closure

Primary outcomes

  1. Recurrent hiatal hernia

    Time frame: 10 years

    The incidence of radiologically verified recurrent hiatal hernia

Secondary outcomes

  1. Dysphagia

    Time frame: 10 years

    Dysphagia for liquids and solids were recorded within a four-graded scale stating the frequency of dysphagia episodes with an arbitrary (empirical) cut off for clinical significance. The same dysphagia scoring was also used in a previous rct, from the same institution, comparing different types of antireflux procedures in open surgery.

  2. Gastrointestinal symptom rating scale (GSRS)

    Time frame: 10 years

    A validated questionnaire containing five dimensions of abdominal symptoms (gastroesophageal reflux, abdominal pain, indigestion, obstipation and diarrhea

  3. Quality of Life, physical and mental score: SF-36

    Time frame: 10 years

    The Swedish version of the validated global Short Form -36 (SF-36) questionnaire was used and data are presented as physical and mental summary component scores (PCS and MCS, respectively)

  4. Proton pump inhibitor (PPI)

    Time frame: 10 years

    Number of patients who report daily intake of PPI at the time of the follow up Use of PPI use of PPI

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Collaborators

  • Ersta Hospital, Sweden

Registry information

Official study title

Hiatal Hernia Repair by Tension-free Mesh Closure or Simple Suturing of the Diaphragmatic Hiatus. Long-term (>10 Years) Follow-up of a Randomized, Double-blind Clinical Trial

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 6, 2021
Registry last updated
Oct 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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