Randomized Controlled Trial of Laparoscopic Primary Diaphragm Repair with Sutures Alone versus Sutures Reinforced with Mesh for Hiatus Hernia: A Long-Term Follow-Up

Randomized Controlled Trial of Laparoscopic Primary Diaphragm Repair with Sutures Alone versus Sutures Reinforced with Mesh for Hiatus Hernia: A Long-Term Follow-Up - PRIME Long-Term Follow-Up

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON53688

Enrollment

Registered

2023-04-12

Start date

2023-04-01

Completion date

Unknown

Last updated

2024-04-09

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

Conditions

hiatus hernia mesh surgery

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Participant of the original PRIME-trial - Alive

Exclusion criteria

Exclusion criteria: - No informed consent - Additional hiatal hernia repair surgery during the follow-up period - Pregnancy - Patients that have stated they do not want to be approached for follow-up research - Patients that do not want to know if they have a recurrence of the hiatal hernia

Design outcomes

Primary

Measure	Time frame
Incidence of recurrent hiatus hernia (integrity of hiatal repair)	—

Secondary

Measure	Time frame
- Clinical recurrence of the hernia (symptomatology) - Development of postoperative reflux disease - Development of postoperative side-effects - Overall satisfaction with surgical outcome - Long-term complications	—

Countries

Netherlands

Outcome results