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

• Conditions: hiatus hernia; mesh surgery; 10000073; 10013369; 10017998

• Registration Number: NL-OMON53688
• Lead Sponsor: Rijnstate Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 70

Inclusion Criteria

- Participant of the original PRIME-trial
- Alive

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

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Incidence of recurrent hiatus hernia (integrity of hiatal repair)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Clinical recurrence of the hernia (symptomatology)<br /><br>- Development of postoperative reflux disease<br /><br>- Development of postoperative side-effects<br /><br>- Overall satisfaction with surgical outcome<br /><br>- Long-term complications</p><br>