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Closing of the hernia defect during laparoscopic ventral hernia repair

Prospective RandOmised Study of Endoscopic fascia Closure and long term Outcome

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN51495042
Enrollment
180
Registered
2016-04-22
Start date
2015-11-18
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Ventral hernia Digestive System

Interventions

The classic approach in laparoscopic ventral hernia repair is to bridge the hernia defect by reinforcement material. In open techniques, a long- established principle is to, when possible, recreate th

Sponsors

Västerbotten County Council
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age >18 years 2. Understand written information in Swedish 3. Primary or incisional hernia of the midline between 2 and 8 cm

Exclusion criteria

Exclusion criteria: 1. Recurrence after previous hernia surgery 2. Laparoscopy not feasible

Design outcomes

Primary

MeasureTime frame
Hernia site complications within twelve months. This includes recurrence of the hernia, sustained clinically significant seroma, and clinically significant and symptomatic pseudo hernia with sliding of the reinforcing material into the aneurysm sac after twelve months.

Secondary

MeasureTime frame
1. Abdominal wall pain, assessed using the Ventral Hernia Pain Questionnaire, before surgery, 3 months after surgery and after 12 months 2. Surgical complications within three months of such as infection, and fistula 3. Operating time 4. Abdominal function measured by Biodex after 12 months

Countries

Sweden

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 7, 2026