Randomized Controlled Trial of Laparoscopic Primary Diaphragm Repair with Sutures Alone versus Sutures Reinforced with Mesh for Hiatus Hernia: A Long-Term Follow-Up

Hiatal hernias are common and may cause a variety of symptoms such as
heartburn, regurgitation and dysphagia which can influence patients* quality of
life. Over the last decades, laparoscopic correction of hiatal hernia gradually
replaced open repair. Initially, the standard approach to laparoscopic repair
of hiatal hernias was hiatal repair with sutures to narrow the hole in the
diaphragm through which the oesophagus enters the abdominal cavity. However,
hiatal hernia repair with sutures alone is associated with a high recurrence
rate. In many other fields of surgery mesh repair has become the standard
method of practice. Especially in inguinal and cicatricial hernia repair, the
use of mesh is associated with a reduction in hernia recurrence.

However, the use of mesh at the hiatus poses an additional risk of adhesion
formation, postoperative dysphagia and esophageal erosion caused by mechanical
mesh irritation. Therefore the potential advantages of mesh repair may be
offset by post-operative symptoms.

The PRIME trial demonstrated that there was no difference in postoperative
dysphagia between the two groups one year after surgery. However, there was
also no difference in recurrence of hiatal hernia demonstrated by barium
swallow radiology or upper gastrointestinal endoscopy one year after surgery.
Watson et al. demonstrated in their cohort that there was no difference in
recurrence - radiologically and clinically - five years after suture versus
non-absorbable mesh repair for large hiatal hernias.

To assess the recurrence of hiatal hernia five to ten years after repair using
sutures versus sutures reinforced with non-absorbable mesh.

Cross-sectional long term follow-up of a randomised controlled trial comparing
two laparoscopic procedures for hiatal hernia repair.

The results of this study will tell us if there is a benefit or decreased
benefit of using mesh in hiatal hernia surgery. This could impact the current
standard of care. The risks for the participants of this study are low.
Subjection to X-ray radiation of modern CT scanning devices is considered safe,
although it is of course a burden.
The patients will visit the hospital only once, to have the CT-scan.
Also they will be asked to fill out a relatively short questionnaire