NCT05069493

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2021

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 26, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 6, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

October 18, 2022

Status Verified

October 1, 2022

Enrollment Period

7 months

First QC Date

September 26, 2021

Last Update Submit

October 16, 2022

Conditions

GERDHiatal HerniaDysphagia, EsophagealQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Recurrent hiatal hernia

    The incidence of radiologically verified recurrent hiatal hernia

    10 years

Secondary Outcomes (4)

  • Dysphagia

    10 years

  • Gastrointestinal symptom rating scale (GSRS)

    10 years

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

    10 years

  • Proton pump inhibitor (PPI)

    10 years

Study Arms (2)

Tension-free

Hiatal hernia repair by tension-free mesh closure

Procedure: mesh

Suturing

Hiatal hernia repair by simple suturing of the diaphragmatic

Procedure: simple suturing

Interventions

simple suturingPROCEDURE

Hiatal hernia repair by simple suturing of the diaphragmatic

Suturing
meshPROCEDURE

Hiatal hernia repair by tension-free mesh closure

Tension-free

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who were included in the previous study (hiatal hernia repair by tension-free mesh closure or simple suturing) and are available for inclusion at the long-term follow-up.

You may qualify if:

  • Patients available at the time of follow-up

You may not qualify if:

  • Deceased
  • Declined participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ersta Hospital

Stockholm, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 37819652DERIVED

MeSH Terms

Conditions

Gastroesophageal RefluxHernia, HiatalDeglutition Disorders

Interventions

Melanocyte-Stimulating Hormones

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesHernia, DiaphragmaticInternal HerniaHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPharyngeal DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

MelanocortinsPro-OpiomelanocortinHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPituitary Hormones, AnteriorPituitary HormonesNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteins

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

September 26, 2021

First Posted

October 6, 2021

Study Start

September 15, 2021

Primary Completion

March 30, 2022

Study Completion

June 30, 2022

Last Updated

October 18, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)