The DYNAMIC Study - comparing standard stitch repair versus mesh-and-stitch repair of large hiatus hernias
Not Applicable
- Conditions
- Surgical repair of hiatus herniaDigestive SystemLarge hiatus hernia Gastro-oesophageal reflux disease (GERD)
- Registration Number
- ISRCTN76437720
- Lead Sponsor
- Portsmouth Hospital NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 40
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 1. Quality of life, assessed pre-operation, and 3 months, 6 months, 9 months, and 1, 2 and 3 years post-operation, using:<br> 1.1. Gastro-oesophageal Reflux Disease Health-related Quality of Life Questionnaire (GERD-QOL)<br> 1.2. EuroQol-5D (EQ-5D)<br> 2. Size of hernia in cm, assessed using the barium swallow test pre-operation and 1 year post-operation<br> 3. Mesh position, assessed 1 year post-surgery using magnetic resonance imaging (MRI)<br> 4. Feasibility, based on trial delivery and surgery process indicators<br> 5. Safety in each group during surgery and up to 1 year post-surgery<br>
- Secondary Outcome Measures
Name Time Method