Improving Patient Outcomes in Anti-Reflux Surgery
Digestive Health experts join a multicenter clinical trial to determine the best surgical techniques for GERD patients with hiatal hernia
Reviewed by: F.P "Tripp" Buckley III, MD
Written by: Lauren Schneider
UT Health Austin physicians joined a multicenter clinical trial comparing two surgeries to treat chronic acid reflux also known as gastroesophageal reflux disease (GERD). Led by the Mayo Clinic, the clinical trial will compare long-term outcomes associated with the two procedures.
“Our research question centers on whether the classic Nissen fundoplication remains the ‘gold standard’ of surgical therapy,” says F. P. “Tripp” Buckley, MD, FACS, who serves as the Surgical Director of Digestive Health, a clinical partnership between Ascension Seton and UT Health Austin. Dr. Buckley will oversee Digestive Health’s involvement in the clinical trial.
Relationship Between GERD and Hiatal Hernia
GERD is caused by weakness in the lower esophageal sphincter (LES), a muscle within the gastroesophageal junction that separates the esophagus from the stomach. This allows stomach acid and bile to flow up and into the throat. Over time, patients may experience serious esophageal pain and even long-term tissue damage.
<br>Along with the LES, the gastroesophageal junction is also regulated by a muscle known as the diaphragm, which separates the stomach and the chest. Because the LES and the diaphragm both play a role in regulating the gastroesophageal junction, GERD is often linked to hiatal hernia, a condition in which stomach tissue pushes into the chest though a small opening (hiatus) in the diaphragm.
Two Surgical Approaches to GERD Care
The most common surgical intervention in GERD patients is Nissen fundoplication. This procedure is laparoscopic, meaning the surgeon only makes a small incision to access the targeted organs. In Nissen fundoplication, a barrier is reconstructed by folding the top (fundus) of the stomach 360° around the esophagus. This barrier is then held in place with three sutures.
A newer, less invasive surgery used to treat GERD is known as transoral incisionless fundoplication (TIF). In this procedure, the surgeon passes a TIF device into the patient’s mouth and through their throat. An endoscope attached to the TIF device allows the surgeon to view the gastroesophageal junction. The TIF device then folds the stomach 270° around the esophagus, fastening it with twenty plastic tacks that remain in the body.
“As a standalone procedure, TIF has some proven success in patients with no hernia, but we can do better. Furthermore, we now recognize the value in a proper esophageal dissection and appropriate closure of the diaphragm,” says Dr. Buckley, who attributes this incomplete recovery to the combined role the diaphragm and LES play in stopping acid reflux. “Even though you might not have a hiatal hernia, the diaphragm may not be doing its entire job. We need to take care of both, even without a significant hiatal hernia.”
Historically, Nissen fundoplication has served as the standard method of treating GERD patients, which Dr. Buckley ascribes to the fact that it nearly always combines hiatal dissection and closure. While the Nissen is the current gold standard, it is only offered to a mere 0.5% of patients who would qualify for the surgery. “The issue with the Nissen and all fundoplications is that it takes years of training and continuous performance of the operation to get and stay good at it,” notes Dr. Buckley. “We need an easier, more trainable, and reproducible operation.”
TIF can also be performed in combination with hiatal hernia repair in what is known as combined TIF, or cTIF. However, the medical community is uncertain how long-term outcomes of cTIF compare to those of Nissen fundoplication with hiatal hernia repair. The objective of this clinical trial is to observe the outcomes associated with the two procedures in over 140 patients over the span of five years.
Assessing Long-Term Surgical Outcomes
Participants will first learn about both procedures before being randomly assigned to receive either cTIF or Nissen fundoplication with hiatal hernia repair. These patients will be blinded, meaning they will not know what surgery they receive until they complete a follow-up appointment six months after their procedure.
At this appointment, patients will report their subjective view of the surgery’s effectiveness in preventing reflux. By measuring the acidity of patient’s throats, researchers will more objectively determine the degree to which participants still experience reflux.
Clinicians involved in the clinical trial will continue to follow up with patients for five years, during which time they may also collect radiology data to better understand the impacts of the two surgeries over time.
Research, the Digestive Health Way
Digestive Health was selected as one of six clinics involved in this clinical trial because of the large number of gastroesophageal surgeries performed at the practice, including Nissen fundoplication’s and TIFs. “We’re lucky to perform a high volume of these types surgeries and happy to contribute to this important work with our friends at the Mayo Clinic,” shares Dr. Buckley.
Other Digestive Health practitioners contributing to the trial are UT Health Austin gastroenterologist David Tang, MD, and Elisa Furay, MD, who serves as the Medical Director of the Heartburn and Esophageal Disorders speciality practice within Digestive. Dr. Furay also serves as Dr. Buckley’s surgical partner.
“In our clinic, we’ve got gastroenterology and surgery working side by side,” says Dr. Buckley. “To make the best decisions for patients, we like to do things collaboratively.”