Perioperative PPI Therapy Reduces Incidence of Pharyngocutaneous Fistula

Does perio-perative proton pump inhibitor therapy reduce the incidence of pharyngocutaneous fistula?

Background: Pharyngocutaneous fistula is a common complication of total laryngectomy. A high incidence of gastroesophageal reflux disease, which causes injury to upper aerodigestive tract mucosa, has been noted in patients with larynx cancer. It is unknown if peri-operative proton pump inhibitor (PPI) therapy can reduce the incidence of post-operative fistula.

Study design: Prospective randomized placebo-controlled double blind randomized controlled trial of 14 days of enteral omeprazole versus placebo in patients undergoing primary total laryngectomy for T3/T4 tumors without flap closure. A 20 mg dose was given the day before surgery and then once daily beginning on the second post-operative day. Patients with a history of prior radiation or reflux were excluded.

Setting: Groote Schuur Hospital, University of Cape Town, South Africa.

Synopsis: A total of 40 patients were included. Concurrent neck dissection was performed in 39 patients. There were 21 patients randomized to omeprazole and 19 patients to the placebo arm. No statistically significant differences were observed between groups with respect to patient or tumor factors. A total of seven patients (18%) developed a pharyngocutaneous fistula. There was a statistically signficant difference in fistula incidence between groups. There were six fistula in the placebo arm (32%) while one fistula occured in the omeprazole group (5%; P<0.05). Patients who developed a fistula had a significantly longer length of hospitalization (median, 34 days) compared to those who did not develop a fistula (median, seven days).

Bottom line: These data suggest that peri-operative reflux prophylaxis with PPI therapy is associated with a significant reduction in the incidence of post-operative pharyngocutaneous fistula in patients undergoing primary total laryngectomy.

Citation: Stephenson KA, Fagan JJ. Effect of perioperative proton pump inhibitors on the incidence of pharyngocutaneous fistula after total laryngectomy: A prospective randomized controlled trial. Head Neck. 2015;37:255-259.

—Reviewed by Christine G. Gourin, MD