Longitudinal Sleeve Gastrectomy Study Comparing Posterior Crural Repair Versus No Repair

Longitudinal Sleeve gastrectomy is a type of Bariatric surgery where the stomach is divided
vertically, reducing it to about 25% of its original size. Obesity itself is an independent
risk factor for Gastroesophageal reflux disease (GERD); however it has been observed in the
bariatric surgical community that many Longitudinal Sleeve Gastrectomy (LSG) patients are
complaining of persisted GERD symptoms after LSG surgery. The incidence of GERD in these
patients have been reported to be as high as 26%. GERD is an uncomfortable and dangerous
disease, and if remains unchecked, it can cause ulcer disease, esophagitis, and even
esophageal cancer. Because of this, bariatric surgeons want to reduce incidence of GERD
after LSG, which led to multiple additions to the LSG procedures, which are currently being
examined, namely, combined fundoplication with the sleeve, banded sleeve and a combined
hiatal repair with SG. However, there have been no randomized comparative clinical trials to
evaluate GERD as an endpoint after LSG.

Of all the possible solutions to treat increased reflux after LSG, mentioned previously,
repairing the hiatus at the time of surgery makes the most sense physiologically. LSG
dissection requires the obliteration of the left phrenoesophageal ligaments that hold the GE
junction in place. This essentially creates a weakness in the hiatus that can lead to hiatal
hernia and subsequent reflux disease. Crural repair at the time of surgery strengthens the
GE junction and reduces the possibility of hiatal hernia formation. Closing the crus around
the esophagus may prevent the sleeve from herniating into the chest and reduces the
occurrence of reflux by repositioning the GE junction into it0s normal location in the
abdomen.

INCLUSION CRITERIA:

- The subject is between the ages of 21 and 65

- The subject is able to provide informed consent

- The subject is able and willing to comply with the study protocol

- Patients are will to refrain from the use of specified antacid medications such as
PPIs (e.g. Nexium, Prilosec, Omeprazole, etc) or H2 blockes (e.g. Pepcid, Zantac,
etc)

- The subjects meets the requirement for bariatric surgery as defined by the 1991 NIH
consensus on bariatric surgery

- BMI ≥40 or BMI = 35-39 with one or more obesity-related comorbidities.

- Patients should have attempted, and failed, several structured methods of weight loss
The subject is approved to have a sleeve gastrectomy

EXCLUSION CRITERIA:

- The subject is not able to provide informed consent

- The subject is not willing to comply with the study protocol

- The subject has had previous foregut (stomach) surgery

- The subject has evidence of a gastric tumor, ulcer, or other abnormalities at the
time of EGD that would preclude them from having a sleeve gastrectomy

- Severe esophagitis or Barrett's esophagus will exclude them from the study

- The surgeon concludes that the patient is not a candidate for sleeve gastrectomy
based on his clinical judgment