Randomized Controlled Trial of Laparoscopic Primary Diaphragm Repair with Sutures Alone versus Sutures Reinforced with Mesh for Hiatus Hernia.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON23150

Enrollment

Registered

2013-01-03

Start date

2013-02-01

Completion date

Unknown

Last updated

2024-06-11

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

Conditions

Hiatus Hernia

Interventions

Patients will be randomized to undergo a laparoscopic primary repair with sutures alone or sutures augmented with prosthetic mesh.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age ≥ 18 years; 2. Hiatus hernia; 3. Laparoscopic surgical repair clinically indicated; 4. Fit for surgery; 5. Suitable for both procedures.

Exclusion criteria

Exclusion criteria: 1. Age < 18 years; 2. No informed consent; 3. Previous anti-reflux surgery or repair for hiatus hernia; 4. Pregnancy.

Design outcomes

Primary

Measure	Time frame
Integrity of the hiatal repair is the main endpoint.	—

Secondary

Measure	Time frame
Secondary objectives include clinical recurrence of the hernia, development of post-operative reflux disease, postoperative side effects and overall satisfaction with surgical outcome.	—

Contacts

Public ContactD.J.G.H. Roks

Postbus 2500

d.roks@antoniusziekenhuis.nl+31 (0)30 6099111

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)