The DYNAMIC Study - comparing standard stitch repair versus mesh-and-stitch repair of large hiatus hernias

A randomised controlled feasibility trial of a novel polyvinylideneflouride (PVDF) mesh (DYNAMesh-hIatus) Cruroplasty versus suture only repair of large hiatus hernia

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN76437720

Enrollment

Registered

2018-11-19

Start date

2019-07-30

Completion date

Unknown

Last updated

2020-04-06

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

Conditions

Surgical repair of hiatus hernia Digestive System Large hiatus hernia Gastro-oesophageal reflux disease (GERD)

Interventions

Participants are randomised into the intervention and control groups using the two-tier sealed envelope method in the operating theatre. Participants and outcome assessors will be blinded to treatment

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
1. Quality of life, assessed pre-operation, and 3 months, 6 months, 9 months, and 1, 2 and 3 years post-operation, using: 1.1. Gastro-oesophageal Reflux Disease Health-related Quality of Life Questionnaire (GERD-QOL) 1.2. EuroQol-5D (EQ-5D) 2. Size of hernia in cm, assessed using the barium swallow test pre-operation and 1 year post-operation 3. Mesh position, assessed 1 year post-surgery using magnetic resonance imaging (MRI) 4. Feasibility, based on trial delivery and surgery process indicators 5. Safety in each group during surgery and up to 1 year post-surgery	—

Measure

Time frame

1. Quality of life, assessed pre-operation, and 3 months, 6 months, 9 months, and 1, 2 and 3 years post-operation, using: 1.1. Gastro-oesophageal Reflux Disease Health-related Quality of Life Questionnaire (GERD-QOL) 1.2. EuroQol-5D (EQ-5D) 2. Size of hernia in cm, assessed using the barium swallow test pre-operation and 1 year post-operation 3. Mesh position, assessed 1 year post-surgery using magnetic resonance imaging (MRI) 4. Feasibility, based on trial delivery and surgery process indicators 5. Safety in each group during surgery and up to 1 year post-surgery

—

Secondary

Measure	Time frame
1. The following trial indicators: 1.1. Number of eligible participants 1.2. Proportion of patients consenting to the trial 1.3. Proportion of participants completing the study 2. The following surgical indicators: 2.1. Number of patients with initial operation 2.2. Follow-up period completed as per allocated treatment group 3. Adverse events occurring peri- and post-operatively up to 1 year after surgery, collected using an approved Serious Adverse Events Case Report Form 4. Operation time in minutes 5. Blood loss during operation, assessed using a standard blood loss measurement using blood volume in ml from suction and swab weight 6. Unplanned re-admission to theatre, collected using an approved Serious Adverse Events Case Report Form by the research team, including timing, reason and outcome 7. Length of hospital stay in days, assessed using a Case Report Form by the research team 8. Time for patients to return to work/normal activities in weeks, assessed using a patient diary 9. Post-operative recognised side effects of surgery, assessed at the 3 month follow-up using a daily patient diary, including: 9.1. Duration of resolution of dysphagia to solids 9.2. Pain 9.3. Gas bloating	—

Measure

Time frame

1. The following trial indicators: 1.1. Number of eligible participants 1.2. Proportion of patients consenting to the trial 1.3. Proportion of participants completing the study 2. The following surgical indicators: 2.1. Number of patients with initial operation 2.2. Follow-up period completed as per allocated treatment group 3. Adverse events occurring peri- and post-operatively up to 1 year after surgery, collected using an approved Serious Adverse Events Case Report Form 4. Operation time in minutes 5. Blood loss during operation, assessed using a standard blood loss measurement using blood volume in ml from suction and swab weight 6. Unplanned re-admission to theatre, collected using an approved Serious Adverse Events Case Report Form by the research team, including timing, reason and outcome 7. Length of hospital stay in days, assessed using a Case Report Form by the research team 8. Time for patients to return to work/normal activities in weeks, assessed using a patient diary 9. Post-operative recognised side effects of surgery, assessed at the 3 month follow-up using a daily patient diary, including: 9.1. Duration of resolution of dysphagia to solids 9.2. Pain 9.3. Gas bloating

—

Countries

United Kingdom

Contacts

Public ContactSimon Khay Chuan Toh

simon.toh@porthosp.nhs.uk02392286885

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026