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

NCT ID: NCT05069493

Last Updated: 2022-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

103 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-15

Study Completion Date

2022-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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GERD Hiatal Hernia Dysphagia, Esophageal Quality of Life

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Tension-free

Hiatal hernia repair by tension-free mesh closure

mesh

Intervention Type PROCEDURE

Hiatal hernia repair by tension-free mesh closure

Suturing

Hiatal hernia repair by simple suturing of the diaphragmatic

simple suturing

Intervention Type PROCEDURE

Hiatal hernia repair by simple suturing of the diaphragmatic

Interventions

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simple suturing

Hiatal hernia repair by simple suturing of the diaphragmatic

Intervention Type PROCEDURE

mesh

Hiatal hernia repair by tension-free mesh closure

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

-Patients available at the time of follow-up

Exclusion Criteria

* Deceased
* Declined participation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ersta Hospital, Sweden

OTHER

Sponsor Role collaborator

Karolinska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Lars Lundell

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ersta Hospital

Stockholm, , Sweden

Site Status

Countries

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Sweden

References

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Analatos A, Hakanson BS, Ansorge C, Lindblad M, Lundell L, Thorell A. Hiatal Hernia Repair With Tension-Free Mesh or Crural Sutures Alone in Antireflux Surgery: A 13-Year Follow-Up of a Randomized Clinical Trial. JAMA Surg. 2024 Jan 1;159(1):11-18. doi: 10.1001/jamasurg.2023.4976.

Reference Type DERIVED
PMID: 37819652 (View on PubMed)

Other Identifiers

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PATCH2

Identifier Type: -

Identifier Source: org_study_id

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