Recurrence rate of hiatal hernia repair with biomesh compared to repair without mesh * a double blinded, randomized, controlled trial.

Repair of a hiatal hernia is a procedure with a high risk of recurrence. Based
on the available literature it is concluded that recurrence rates are lower
when a mesh is used. However, mesh use can cause serious complications such as
mesh erosion which is why many surgeons still prefer crural closure with
sutures. With this study we want to investigate if one of these techniques has
a clear preference in terms of recurrence rates and complications.

There are many contradictions in the literature about using a mesh in the
repair of a hiatal hernia. Recurrence rates up to 43% are reported for
laparoscopic primary closed paraoesophageal hernias. For these operations wrap
migration rates of up to 26% are reported.
A review of five case series, 6 retrospective reviews, 4 prospective randomized
trials and 4 prospective nonrandomized trials showed a recurrence rate of 2.6%
for repair using mesh and 15% without mesh. None of these articles reported an
erosion of the mesh in the gastrointestinal tract.
Of the 986 patients in total who had a mesh in the review of Granderath et al.
there was one patient with a esophageal stenosis, one patient with a
mesh-induced esophageal scarification, one patient with an asymptomatic
esophageal mesh erosion, one patient with a cardiac tamponade secondary to mesh
fixation with tacks (resulting in death), one patient with hiatal fibrosis, 2
patients with hiatal fibrotic damage / esophageal mesh erosion and one patient
with penetration of the cardiac lumen. These complications all occurred in
patients with a synthetic mesh.

The above mentioned literature shows that repair of a hiatal hernia using a
mesh gives fewer recurrences than repair without mesh. However, there are few
prospective randomized controlled trials that provide clear results about this.
The most serious complication of repair with mesh is mesh erosion and based on
previous studies there seems to be a lower risk of erosion using a biomesh.

The study will be a multi-centre double-blinded Randomized Controlled Trial.
The trial is prospective in nature and data will be collected through a digital
database.
50% of the participants in the intervention group will undergo repair of hiatal
hernia through biomesh and the remaining 50% in the control group will receive
a repair without mesh placement.

Intervention:
Laparoscopic hernia repair with biomesh
Control group: Laparoscopic hernia repair without biomesh

The burden on patients for participating in this study is low. All included
patients would also have surgery if they didn*t participate in the study. The
extra burden is in filling in questionnaires.