Randomized Controlled Trial of Laparoscopic Primary Crural Repair versus Primary Repair with Circular Bio-absorbable Hiatal Mesh Reinforcement in Hiatal Hernia Repair

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27270

Enrollment

220

Registered

2017-05-21

Start date

2020-01-01

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

Adults with giant hiatal hernia`s.

Interventions

1. Laparoscopic primary hiatal hernia repair and 180 degrees fundoplication. 2. Laparoscopic primary hiatal repair with circular bio-absorbable mesh reinforcement and 180 degrees fundoplication.

Eligibility

Inclusion criteria

Inclusion criteria: - Age > 18 years - Hiatus hernia type II-IV - Laparoscopic surgical repair clinically indicated - Fit for surgery - Suitable for both procedures

Exclusion criteria

Exclusion criteria: - Age < 18 years - Hiatus hernia type I. - No informed consent - Previous anti-reflux surgery or repair for hiatus hernia - Pregnancy - Achalasia

Design outcomes

Primary

Measure	Time frame
Radiologic recurrence rate (CT-scan) of hiatal hernia.	—

Secondary

Measure	Time frame
- Development of post-operative dysphagia. - Overall satisfaction with surgical outcome. - Major complications „X Postoperative hemorrhage with necessity for reoperation „X Organ perforation (stomach, esophagus, small intestine, colon) „X Major hemorrhage (>500cc) during operation „X Lung or cardiac injury during operation - Minor complications „X Surgical site infection „X Minor bleeding (<500cc) during operation „X Postoperative pneumonia „X Postoperative urinary tract infection „X Postoperative deep venous thrombosis	—

Measure

Time frame

- Development of post-operative dysphagia. - Overall satisfaction with surgical outcome. - Major complications „X Postoperative hemorrhage with necessity for reoperation „X Organ perforation (stomach, esophagus, small intestine, colon) „X Major hemorrhage (>500cc) during operation „X Lung or cardiac injury during operation - Minor complications „X Surgical site infection „X Minor bleeding (<500cc) during operation „X Postoperative pneumonia „X Postoperative urinary tract infection „X Postoperative deep venous thrombosis

—

Contacts

Public ContactJ.W.A. de Haas

Isala Zwolle

j.w.a.de.haas@isala.nl0617704702

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)