A surgical procedure trial compares efficacy of two reliable procedures to repair a hiatal hernia and put an end to heartburn and GERD symptoms

For years, Mike Culp, 30, followed a highly restrictive diet and took medication to help manage his painful acid reflux symptoms that plagued his life and sleep. At age 18, he went to a specialist, who diagnosed him with gastroesophageal reflux disease (GERD). He was prescribed a proton-pump inhibitor (PPI), a medication that shuts off the acid-pumping cells in the stomach. His symptoms were temporarily managed, but he could not get rid of the burning, acidic-induced discomfort for long.

“It was killing me, and it wasn’t so much specific foods, but just everything across the board. Anything could set me off,” Culp said. “After eating or drinking, I would get bad heartburn and I needed to wait three or four hours before going to sleep. As a nurse, I work long shifts, so it is unreasonable for me to eat and wait hours before lying down.”

Culp rarely got a full night’s rest due to his intense symptoms, such as regurgitation and aspiration of stomach acid that entered his airway and lungs while he slept. He was later diagnosed with asthma and reactive airways disease, which occurs when the bronchial tubes that bring air into your lungs overreact to an irritant, like stomach acid. The tiny airway tubes can swell and cause breathing problems.

Because of the repeated acid-related damage of Culp’s esophageal lining, he was also at risk for developing esophageal cancer. In order to reduce the risk of an asthma flare, Culp had to avoid wearing cologne, smelling certain cleaning products, and being near campfires or any type of smoke.

According to the National Institutes of Health, GERD is one of the most common gastrointestinal disorders, affecting approximately 20% of adults in the United States. Additionally, it is the second most common reason people see a gastroenterologist, also known as a GI specialist.

Referred by his gastroenterologist, Culp met with Todd Wilson, MD, an associate professor of surgery at McGovern Medical School at UTHealth Houston. Wilson’s team diagnosed Culp with a para-esophageal hiatal hernia, a condition where the stomach pushes up into the chest and esophagus, allowing acid to enter the throat, causing heartburn, regurgitation of food, and severe bloating.

“It can run in the family just like appearance. We all look different on the outside and can look different on the inside. Some people are born with larger hiatal defects than others and may experience symptoms that aren’t completely resolved with medications,” said Wilson, a surgeon who specializes in minimally invasive gastrointestinal procedures with UTHealth Houston and Memorial Hermann.

Wilson recommended a fundoplication surgery, which involves partially wrapping the top of the stomach, called the fundus, and sewing it around the lower esophagus to reinforce the anti-reflux valve at the top of the stomach called the gastroesophageal flap valve. Tightening the valve creates a better barrier to reduce the likelihood of acidic stomach contents from entering the esophagus.

Culp’s size of his esophagus and hernia allowed him to choose from many different fundoplication options. He ultimately decided on the partial wrap procedure that was recommended. Since his surgery in July 2021, Culp no longer has asthma flares, and was able to stop taking the PPI medication, which enabled him to lose nearly 30 pounds. Two years later, he has been very happy with the results and has seen a dramatic improvement in his health and quality of life.

For patients experiencing symptoms of GERD which may be due to a hiatal hernia, Wilson and R. Tomas DaVee, MD, an assistant professor in the Department of Surgery at McGovern Medical School, are leading a clinical trial at UTHealth Houston that is comparing long-term outcomes following two well-known fundoplication surgeries to correct the hiatal hernia: combined transoral incisionless fundoplication (CTIF) and laparoscopic nissen fundoplication (LNF). Co-investigators of the multicenter, randomized, single-blind study will determine the safest and most effective minimally invasive procedure.

The national trial is recruiting 142 patients, ages 20 to 80, who will be screened through a number of tests to determine if they are eligible for the trial. DaVee will evaluate the patient’s esophagus muscle strength, measure the volume of acid reflux present, and take detailed measurements of the gastroesophageal flap valve and hiatal hernia. Researchers will follow patients up to five years after surgery to track their acid reflux levels and GERD symptoms.

There are 68 patients enrolled in the trial so far.

“My hope is that people will learn that there are other options to long-term medication. There are ways that we can help people whose medications are not working very well, or who don’t particularly want to be on medications for a long time,” DaVee said.

Other UTHealth Houston co-investigators of the study include Erik Wilson, MD, professor and Lynn and Oscar Wyatt Chair in Metabolic Research and director of the division of elective surgery at McGovern Medical School; and Nirav Thosani, MD, associate professor and Atilla Ertan, MD, Endowed Chair in Gastroenterology, Hepatology and Nutrition at McGovern Medical School and director of the Center for Interventional Gastroenterology at UTHealth Houston.

The trial is supported by Endogastric Solutions.