Sleeve Gastrectomy and the Influence of Concomitant Hiatal Hernia Repair

Bariatric surgery is considered a safe and effective treatment for (morbid)
obesity. Gastroesophageal reflux disease (GERD) is common among obese patients,
both before and after bariatric surgery. It is well accepted that Laparoscopic
Roux-en-Y Gastric Bypass (LRYGB) leads to a decrease in postoperative GERD.
Despite the fact that the laparoscopic sleeve gastrectomy (LSG) is increasingly
popular worldwide, and gradually starts to be more frequently performed than
LRYGB, it still remains unclear what the exact effect of LSG on the
postoperative prevalence of GERD and the development of denovo GERD is. The
presence of a (small) hiatal hernia (HH) is believed to be a risk factor for
GERD following LSG. However, there is a lack of clear cut guidelines and
clinical trials / prospective studies comparing LSG with and without combined
repair of small hiatal hernias, and the effect of both treatments on
postoperative GERD symptoms and esophageal acid exposure.

To define the exact effect of LSG with and without concomitant HH repair on the
prevalence of GERD and GERD-related symptoms in obese patients who are
intraoperatively diagnosed with a small HH. Furthermore, to examine the effect
of LSG on the postoperative prevalence of GERD and related symptoms in obese
patients without a HH.

Prospective blinded randomized controlled clinical trial comparing LSG alone
with LSG+HH repair in obese patients with a small HH.

All 80 patients will undergo an additional pre-operative and three and 12
months postoperative combined pH-impedance and high-resolution manometry (HRM)
examination in addition to the standard pre-and postoperative care for patients
undergoing LSG. Furthermore, all patients will be asked to complete a pre- and
postoperative questionnaire at three and 12 months following surgery concerning
reflux symptoms, dysphagia, and quality of life. Patients with an
intraoperatively diagnosed fingerprint indentation of the diaphragm, a small
dimple surrounding the point where the esophagus passes through the diaphragm
and known to possible indicate the presence of a HH, and with the HH measuring
< 5cm following exploration, are intra-operatively being randomized for either
LSG alone or LSG with concomitant HH repair. For those patients randomized for
HH repair, dissection and reduction of the hernia sac will be performed
followed by posterior crural closure using non-absorbable sutures. Additional
anterior sutures are used if deemed necessary.

Included patients will undergo a 24 hours combined pH-impedance monitoring and
HRM prior to and three months and one year following surgery, next to the
standard pre-operative workup for bariatric surgery. Both HRM and 24-hour
combined pH-impedance monitoring are safe procedures without any medical risks.
The procedure consists of nasal introduction of a flexible catheter into the
esophagus. Potential burdens include the gag-reflex during the placement of the
catheter for combined pH-impedance monitoring and HRM. Questionnaires focussing
on GERD-symptoms, dysphagia and quality of life will be filled in
pre-operatively and three and 12 months following surgery, which will take
approximately 15 minutes in total. During surgery, the presence of a small HH
(<5 cm) will be assessed, after which the patient will be randomized for either
LSG with concomitant HHR or LSG alone. Additional HH repair will take less than
10 minutes and the medical risks consist of bleeding of one of the hiatal
pillars and/or postoperative dysphagia.