For initial credentialing, surgeons had to certify hospital credentialing for the modality they would be using and a minimum of 20 cases of surgical experience. They had to submit 10 cases with paired operative notes and pathology reports over a two-year period to an expert panel (Oral Oncol. 2020;110:104797). After approval, margin status and bleeding were monitored by the committee at every five cases. There were 120 surgeons who applied, and 87 were approved, with some not approved after they failed to respond to requests for more cases to be submitted, Dr. Ferris said.
Explore This IssueMarch 2021
The results of the surgeries in the trials showed that the credentialing process seems to have been a success, he said. Just under 4% of the cases had positive margins, and about 5% had grade 3 or 4 bleeding. “That, I think, gives a model for future surgical trials,” Dr. Ferris said. A similar process is now being used in a trial on surgical node biopsy, he added.
Looking back, Dr. Ferris said it would have been beneficial to also credential the clinical research staff, since some patients became ineligible during the trial, despite a quality surgery, because of untimely imaging or other wrinkles. “If it’s in the eligibility list … it doesn’t matter how good a surgery is or how great your radiation therapy is, they will be deemed ineligible later,” he said. “Some of the clinical research teams could have been a little bit more experienced.”
Carol Lewis, MD, MPH, associate professor of head and neck surgery at the University of Texas MD Anderson Cancer Center in Houston, described the quality outcomes associated with the department’s Enhanced Recovery After Surgery (ERAS) program for head and neck surgery with free flap reconstruction.
The program includes an extensive checklist of items performed before, during, and after surgery, and at follow-up, including providing preoperative patient education, limiting sedatives, using a set premedication regimen, using goal-directed fluid therapy, providing opioid-sparing anesthesia, encouraging early mobilization, removing catheters early, and offering coordinated follow-up and support.
Researchers found that, compared to those in a non-ERAS group, those participating in the program had a lower rate of ICU stays, a lower length of stay, a lower morphine equivalence, and a lower overall rate of complications (Ann Surg Oncol. 2021;28:867-876).
In addition, a meta-analysis and systematic review of 18 studies on ERAS programs for head and neck surgery with free flap reconstruction found that ERAS was linked with a reduced length of stay, a lower rate of readmission, and a lower rate of wound complications, but no difference in ICU length of stay, unplanned re-operation, or mortality (Oral Oncol. 2021;113:105117).
Dr. Lewis said that the balanced approach to using pain medication might have helped the most, helping patients through the post-analgesia care unit (JAMA Otolaryngol Head Neck Surg. 2020;146:708-713). She said one challenge is knowing to not reach too far with too many steps right away to get buy-in. “We’ve really had to stagger some things to make it a little more palatable and easier for people to wrap their brains around.”