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Recurrence rate of hiatal hernia repair with biomesh compared to repair without mesh * a double blinded, randomized, controlled trial.

Recurrence rate of hiatal hernia repair with biomesh compared to repair without mesh * a double blinded, randomized, controlled trial. - Herbi Trial

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON36174
Enrollment
100
Registered
2011-07-19
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diaphragmatic hernia hiatal hernia

Interventions

Intervention: Laparoscopic hernia repair with biomesh Control group: Laparoscopic hernia repair without biomesh

Sponsors

Atrium Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients diagnosed with a diaphragmatic hernia Patients older than 18 years Patients under 75 years ASA 1, 2 and 3

Exclusion criteria

Exclusion criteria: Lack of informed consent Recurrent diaphragmatic hernia Previous upper abdominal surgery Pregnancy Immunocompromised patients Use of steroids ASA IV and higher

Design outcomes

Primary

MeasureTime frame
Recurrence rate (anatomical) in both intervention and control group Percentage of mesh erosions in the intervention group Percentage of mesh wrap migrations Complaints of pain, reflux or dysphagia in both groups—

Secondary

MeasureTime frame
Operative time Length of hospital stay Mesh infections Wound infections Gastrointestinal quality of life index (GIQLI)—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)