ISRCTN76437720
Active, Not Recruiting
N/A
A randomised controlled feasibility trial of a novel polyvinylideneflouride (PVDF) mesh (DYNAMesh-hIatus) Cruroplasty versus suture only repair of large hiatus hernia
Portsmouth Hospital NHS Trust0 sites40 target enrollmentNovember 19, 2018
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Surgical repair of hiatus hernia
- Sponsor
- Portsmouth Hospital NHS Trust
- Enrollment
- 40
- Status
- Active, Not Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. NHS patients undergoing:
- •1\.1\. Elective laparoscopic repair of large hiatus hernia (\>5 cm in size)
- •1\.2\. Fundoplication for gastro\-oesophageal reflux disease
- •2\. Fulfil criteria for keyhole surgery
- •3\. Aged 18 years or older
- •4\. Body mass index \<40 kg/m²
- •5\. Able to provide written informed consent
Exclusion Criteria
- •1\. Concomitant medical condition likely to shorten survival to less than 1 year
- •2\. Previous hiatus hernia surgery
- •3\. Active treatment for any cancer
- •4\. Pregnancy
- •5\. Contraindications to MRI for supplementary MRI study (can still be recruited into the study, but not for the MRI study at 1 year), including:
- •5\.1\. Any metal implants
- •5\.2\. Pacemaker
- •5\.3\. Reveal devices
Outcomes
Primary Outcomes
Not specified
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