American College Of Surgeons - Inspiring Quality: Highest Standards, Better Outcomes

Daily Highlights: Monday, October 5

Long-awaited CODA trial finds antibiotics are a safe option in the short term for many appendicitis patients

The first results from the long-awaited Comparison of Outcomes of Drugs and Appendectomy (CODA) trial suggest antibiotics are a safe first-line treatment for many patients with appendicitis, researchers reported Monday at Clinical Congress. The study, which was simultaneously published in the New England Journal of Medicine, found that after 90 days, just three in 10 patients given antibiotics later had an appendectomy.

Despite evidence from European studies over the past 25 years that antibiotics may successfully treat patients with appendicitis, a recent study found less than 5 percent of all U.S. patients with appendicitis receive nonoperative treatment. According to CODA co-principal investigator David R. Flum, MD, MPH, FACS, professor and associate chair of surgery at the University of Washington (UW) School of Medicine, Seattle, evidence gaps including the number of patients with perforation or appendicolith, inconsistent use of diagnostic imaging, and use of mostly open versus laparoscopic surgery are key reasons why U.S. surgeons have been reluctant to change practice. CODA, a large-scale, pragmatic, randomized controlled trial comparing appendectomy to antibiotics-first for the treatment of uncomplicated appendicitis, was designed to answer many of these questions.

“Patients care about whether there are options that are less invasive and less costly, and curveballs like COVID-19 cause us to challenge the role of health care interventions,” Dr. Flum said. “We want to help patients and surgeons make better decisions based on the patient’s own unique characteristics, preferences, and priorities.”

In contrast to previous studies, CODA included patients with an appendicolith and those with more severe disease. The final patients were enrolled in early 2020, and researchers expedited their analysis because of increased interest in offering antibiotics to patients who are wary of having a hospital procedure during the COVID-19 pandemic.

The 90-day results presented at Clinical Congress show seven in 10 patients with appendicitis safely avoided appendectomy for at least several months by receiving a course of antibiotics. This included 41 percent of patients with an appendicolith and 25 percent without an appendicolith. The antibiotics group had a higher rate of complications (8.1 versus 3.5 per 100), but when researchers controlled for the presence of an appendicolith, there was almost no difference in complications between the two groups. Patients given antibiotics missed 3.4 fewer days of work, and 47 percent avoided hospitalization for their initial treatment.

“In the COVID era, more patients are going to ask their surgeons what they would do if they had appendicitis,” said Sabrina E. Sanchez, MD, FACS, assistant professor of surgery, Boston University School of Medicine. “Patients who are concerned about COVID-19 exposure may choose antibiotics and it may be a better choice for them. For others, not having to worry about appendicitis again may make appendectomy more appealing. These results allow for conversations like this to happen between the patient and the surgeon so they can make the best decision for that patient.”

“For me, the two most important questions CODA answered are the relevance of appendicolith and the risk of progression to perforation while on antibiotics,” said Katherine Fischkoff, MD, a general surgeon at New York-Presbyterian/Columbia University Irving Medical Center, New York. Patients in the antibiotic arm who went on to have an operation didn’t have a higher rate of complications, suggesting their disease did not progress while they were on antibiotics, she said. And unlike other studies, CODA included patients with radiographic evidence of perforation. Researchers found no difference in rates of complication between those with perforation and those without.

“There’s no reason to think that antibiotics allow a patient to progress to perforation,” Dr. Fischkoff said.

Giana H. Davidson, MD, MPH, FACS, a study investigator and an associate professor of surgery at UW School of Medicine, cautioned that without an appendectomy, there is a chance of missing a cancer of the appendix, but this type of cancer is rare. Among all study participants, eight carcinomas were found.

The study was led by surgeons at the UW School of Medicine in Seattle and conducted at 25 U.S. medical centers. It included 1,552 adults, including 46 percent who are Hispanic and 37 percent who said Spanish is their primary language. To help surgeons evaluate the results of the study and help patients better understand their treatment options, CODA investigators have created a downloadable infographic.

A variety of substudies and ancillary studies are planned, including a look at the role of biomarkers and the microbiome in appendicitis. The trial will also grade the accuracy of imaging in diagnosing appendicitis.

Watch the full session, PS325: Antibiotics for Appendicitis? What the Results from the CODA Trial Mean for Your Practice, on the virtual ACS Clinical Congress site.

Blood-clotting medicine could reduce deaths when given during pre-hospital transport

A new study presented during Monday’s Late-Breaking Clinical Trials session found some severely injured trauma patients who received the blood-clotting treatment tranexamic acid (TXA) before arriving at the hospital were more likely to survive than those who didn’t receive it. The study was also simultaneously published in JAMA Surgery.

The four-year, multicenter study led by researchers at the University of Pittsburgh School of Medicine found that TXA did not reduce 30-day mortality in the majority of patients. However, in subgroups of patients who received TXA within the first hour after their injury, and those who had severe shock (systolic blood pressure ≤70 mm Hg), TXA was associated with significantly lower 30-day mortality.

Researchers also found patients given larger doses fared better than those given lower doses. Patients receiving TXA were given 1 g, 2 g, or 3 g doses. All patients receiving TXA were given a 1 g dose prehospital, while those given 2 g or 3 g received repeat doses in-hospital. The subgroup receiving 3 g saw the greatest 30-day mortality benefit.

TXA is commonly used in some cardiac procedures to control bleeding, and previous studies have suggested it may pose a risk of blood clots or stroke. This study found patients given TXA didn’t have a higher risk of these complications, suggesting TXA may have a low risk of harm, with the potential to benefit some patients.

“Administering TXA during ground or air transport is safe, and the earlier it’s given, the better,” said Jason Sperry, MD, MPH, FACS, professor of surgery and trauma surgeon at the University of Pittsburgh School of Medicine. “We found those patients with moderate to severe injury who received it early had the most benefit, and those who received a larger dose had greater benefit as well.”
The study involved four Level 1 trauma centers in Pennsylvania, Texas, Utah, and Arizona. A total of 903 patients at risk of bleeding from trauma were enrolled. Recent guidelines endorsed by the American College of Surgeons Committee on Trauma recommend prehospital TXA for some patients, and researchers hope these new data will lead to more widespread use.

Watch the full session, SF314. Clinical Trials/Late-Breaking Abstracts, on the virtual ACS Clinical Congress site.

Improving outcomes for obese patients with gastroesophageal reflux

Until insurance coverage expands, how should surgeons manage GERD in obese patients?

Managing gastroesophageal reflux in obese patients is challenging and insurance coverage for treatment options still lags, leaving patients with limited access to options like gastric bypass. At a panel session on Monday, surgeons discussed how to best treat patients with severe gastroesophageal reflux disease, or GERD, including those who aren’t undergoing a bariatric procedure, as well as those with severe GERD who have already had a bariatric operation.

“Often patients visit us who are obese and have severe GERD, and they aren’t thinking about bariatric surgery,” said panelist Leena Khaitan, MD, FACS, director of the Metabolic and Bariatric Treatment Center at University Hospitals, Cleveland, Ohio. “I feel a responsibility to make sure my patients know their weight has an impact on their GERD. And if they have other comorbidities like diabetes or sleep apnea, I make sure they know these are impacted by their weight too. Then they can understand that they need to address their weight to take care of these problems.”

While fundoplication has been the main surgical treatment for severe GERD, long-term outcomes of fundoplication are poorer for obese patients, Peter T. Hallowell, MD, FACS, associate professor at the University of Virginia, Charlottesville, VA said. Meanwhile, sleeve gastrectomy is the most common bariatric operation in the U.S., making up 60 percent of cases, but 20 percent of patients undergoing the procedure may develop GERD. As a result, gastric bypass may be the best option for many obese patients with GERD. Yet access to the procedure remains limited, because few insurers cover it for treatment of GERD, even though organizations including SAGES and ASMBS now recommend it in their guidelines.

“For patients who qualify for bariatric surgery, gastric bypass is the best option for management of GERD,” Dr. Hallowell said. “For those who don’t, fundoplication is an excellent short-term option, but is less successful over the long term. And for those patients who have failed prior fundoplication, gastric bypass is the best revision option.”

Organizations including SAGES and ASMBS are advocating to expand insurance coverage for gastric bypass, panelists said, and surgeons can help in raising awareness of its value.

“The more we can speak, publish papers and advocate for our patients, the better chance we will have to expand access to more patients,” Dr. Khaitan said.
For patients with GERD who have already had bariatric surgery, an operation to treat their GERD is often a last resort, panelists agreed. According to Dr. Khaitan, some of these patients could be helped if they make better food choices, so a detailed dietary history could be the first step in helping them reduce GERD symptoms. Importantly, patients need to understand that maintaining their weight loss is the best option for keeping GERD at bay.

“Patients need to know the longevity of their weight loss will impact how they feel,” said Sara Hennessy, MD, FACS, assistant professor in the Department of Surgery at UT Southwestern, Dallas, Texas. “If they lose weight just to gain it back, their reflux will come back. They need to maintain that weight loss over time.”

Watch the full session, PS362: Reflux and Obesity: The Optimal Approach, on the virtual ACS Clinical Congress site.

The evolution of cancer research during COVID-19

Cancer research has rapidly evolved to adapt to the COVID-19 pandemic, from more flexible research requirements to reducing the in-person component of clinical trials. However, further action is needed across the cancer ecosystem to reverse the impact of delays in cancer screening, diagnosis, and treatment. Drs. Heidi Nelson and Rick Greene review the relevant key takeaways from the Martin Memorial Lecture delivered by NCI Director Dr. Ned Sharpless.

Watch the full session, NL01: Martin Memorial Lecture: Assuring Progress in Cancer Research during Challenging Times, on the virtual ACS Clinical Congress site.

Highlights from this year's late-breaking clinical trials

This year's Late-Breaking Clinical Trials session included six studies on topics including TXA during trauma transport, synthetic versus biologic mesh for complex open hernia repair, routine postoperative laxative use after elective colorectal surgery, TENS for neurogenic bladder in spina bifida patients, narcotics after appendectomy, and point-of-care ultrasound. Drs. Paula Termuhlen and Edith Tzeng discuss the highlights and surprising study results.

Watch the full session, SF314: Clinical Trials/Late Breaking Abstracts, on the virtual ACS Clinical Congress site.

What’s behind the dramatic drop in lung cancer deaths?

Screening, a reduction in smoking, and new treatments are all contributing to improving survival rates for lung cancer patients. Dr. Douglas Wood discusses takeaways from his John H. Gibbon, Jr., Lecture, including the role of a surgeon in screening and why screening uptake is still so low.

Watch the full session, NL02: John H. Gibbon, Jr., Lecture: Lung Cancer Screening: Saving Lives with Science and Policy, on the virtual ACS Clinical Congress site.

Role of immunotherapy in surgical practice

Immunotherapy is increasingly incorporated into treatment for cancers including lung, breast, and melanoma. Drs. Charlotte Ariyan and Jacqueline Jeruss talk about the vital role surgeons can play in collaborating with other specialists to safely and successfully integrate immunotherapy into patient care. They also discuss the value of contributing to the ongoing study of these novel therapies.

Watch the full session, PS321 Immunotherapy: Practice Changing Guidelines, on the virtual ACS Clinical Congress site.

Advancing surgical education: Learnings from the COVID-19 pandemic

How is COVID-19 transforming surgical education? Drs. Chris Ellison, Anton Sidawy, Mohsen Shabahang, Ajit Sachdeva, and L.D. Britt talk about takeaways from a recent survey of surgical training programs, including the need for telemedicine training and increased learner safety and psychological support, as well as how the ACS Academy of Master Surgeon Educators is using these results to expand resources for educators.

Watch the full session, SL341: Academy Symposium: Transformation of Residency Training in Surgery, on the virtual ACS Clinical Congress site.

Urgent airway management: Surgical and nonsurgical techniques

The first responders to airway emergencies are often surgeons responding to ED codes on the floor or their own patients in the OR. Delays in establishing an appropriate airway can result in significant morbidity and mortality. Drs. Steven Roser and Paula Ferrada talk about the importance of all surgeons knowing how to appropriately treat patients who are in crisis or at risk of an airway emergency.

Watch the full session, PS363: Management of the Airway: All You Need to Know, on the virtual ACS Clinical Congress site.

Long-term benefits of bariatric surgery increasingly clear

While some clinicians see bariatric surgery as a last-resort treatment, increasing evidence suggests it can help in managing diabetes, high blood pressure, and other chronic conditions and even improve cancer outcomes. Drs. Ali Tavakkoli and Henry Buchwald discuss takeaways from an expert panel.

Watch the full session, PS372: Metabolic Surgery: Mechanisms and Clinical Outcomes, on the virtual ACS Clinical Congress site.