Multicentre Randomised Controlled Trial of Laparoscopic Suture vs Mesh for Effective Repair of Large Hiatus Hernia

Not Applicable

Active, not recruiting

• Conditions: Hiatus herna; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Surgery - Other surgery

• Registration Number: ACTRN12605000725662
• Lead Sponsor: Dept of Surgery at Flinders Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11-11
• Last Update Posted: 10 June 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

Large hiatus hernia (more than 50% of stomach in the chest)Laparoscopic surgical repair clinically indicatedFit for surgery.

Exclusion Criteria

No informed consent.Previous surgery for gastro-oesophageal reflux or repair for hiatus herniaPregnant.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Integrity of hiatus hernia repair.[ Measured by Barium meal X-ray at 6 months and 3 yrs, and by clinical follow-up - yearly for up to 20 years.]

Secondary Outcome Measures

Name	Time	Method
Clinical recurrence of the hernia.[ Follow-up for 20 years];The development of post-operative reflux.[ Follow-up for 20 years];The development of post-operative side effects.[ Follow-up for 20 years];Overall satisfaction with the surgical outcome.[ Follow-up for 20 years]