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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12605000725662
Enrollment
126
Registered
2005-11-11
Start date
2006-02-01
Completion date
2012-09-01
Last updated
2025-09-08

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

Conditions

None listed

Brief summary

In a multicentre prospective double-blinded randomized trial, we will compare 3 laparoscopic methods for the repair of large hiatus hernia a) Repair using either sutures alone b) Repair with Biomesh (absorbable) c) Repair with Timesh (non-absorbable). to determine: 1) Short term and long term effectiveness of the hernia repair 2) Risk of postoperative side effects This trial will test the hypothesis that there is no difference in the incidence of recurrent hiatus hernia for the 3 different techniques of repair of large hiatus hernia. The primary outcome will be the integrity of the hiatal repair assessed by barium meal X-ray. Secondary outcomes will include clinical recurrence of the hernia, the development of post-operative reflux, the development of post-operative side effects, and overall satisfaction with the surgical outcome.

Interventions

Laparoscopic surgical repair - sutures alone vs absorbable Biomesh vs non-absorbable Timesh

Sponsors

Dept of Surgery at Flinders Medical Centre
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 6, 2026