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Let the patient beware: the evolving truth about laparoscopic antireflux surgery
EDITORIALS
Let the Patient Beware: The Evolving Truth about Laparoscopic Antireflux Surgery Joel E. Richter, MD
S
ince its description in 1991 by Dallemagne et al. (1), laparoscopic antireflux surgery has grown in popularity as the treatment for severe gastroesophageal reflux disease. In a survey of U.S. hospitals by the National Center for Health Statistics, patient discharges with the International Classification of Diseases, Ninth Revision, Clinical Modification code 44.66 (“other procedures for creation of esophagogastric sphincter competence,” or fundoplication) were 13,000 in 1988, 22,000 in 1993, and 40,000 in 1998 (2). Much of this growth has come with the advent of the minimally invasive laparoscopic operation through the abdomen. However, now that five proton pump inhibitors are available, and omeprazole will soon be available over the counter at its prescription dose, more patients with gastroesophageal reflux disease are asking their family practitioner, internist, or gastroenterologist to help them choose the appropriate long-term treatment for their chronic disease. Two articles by Klaus et al. (3) and Vakil et al. (4) that appear in this month’s Journal give some perspective on the evolving truth about laparoscopic antireflux surgery. Despite marketing terms, such as “minimally invasive” or “keyhole surgery,” laparoscopic antireflux surgery is a fairly involved procedure. General anesthesia is required; most patients are hospitalized for at least 24 hours; and the 30-day surgical mortality ranges from 0.08% to 0.2% (2,5). Causes of death include missed esophageal, gastric, or duodenal perforations; ischemic bowel associated with mesenteric thrombosis; and myocardial infarctions. About 4% to 6% of patients experience immediate perioperative complications that delay their hospital discharge (2,6). The most common complication (1.3%) is early wrap herniation, usually from uncontrolled postprocedure nausea and vomiting, which frequently requires re-operation. Other complications include pneumothorax (1%), which is usually due to a pleural tear
Am J Med. ;114:71–73. From the Center for Swallowing and Esophageal Disorders, Department of Gastroenterology/Hepatology, Cleveland Clinic Foundation, Cleveland, Ohio. Requests for reprints should be addressed to Joel E. Richter, MD, Department of Gastroenterology/Hepatology, A30, Digestive Disease Center, 9500 Euclid Avenue, Cleveland Clinic Foundation, Cleveland, Ohio 44195, or [email protected]. Manuscript submitted August 6, 2002. ©2003 by Excerpta Medica Inc. All rights reserved.
during mediastinal dissection of the hiatal hernia; bowel perforation (0.78%); wound infection (0.11%); and splenectomy (0.06%). The likelihood of splenectomy in the laparoscopic procedure has dropped dramatically to about a hundredth of that reported for the open antireflux operation (2). Postoperative complications after laparoscopic antireflux surgery are common, may be prolonged, and may affect quality of life. A frank discussion of these complications is often overlooked in the enthusiasm to discuss the minimal postoperative abdominal pain from the small port incisions and the more rapid return to full activity and work. However, as emphasized by the authors of the two articles (3,4), complications, such as dysphagia, gas-bloat syndrome, increased flatus, and diarrhea, are common after surgery, with incidences ranging from 25% to 50%, at least in the short term (2– 6). Dysphagia during the early postoperative procedure is probably related to edema and inflammation; it is common, occurring in up to 50% of patients (7). The condition generally resolves in 2 to 3 months and can be managed with a soft-food diet and intermittent bougie dilation. In 3% to 24% of patients, it may persist from 6 months to 1 year (8). In such cases, careful endoscopic and radiographic testing often reveal evidence of an overly long wrap, or a “slipped” fundoplication, which is when the fundoplication has slipped down onto the stomach or up the esophagus onto the chest. The slipped fundoplication usually results from tension on the wrap caused by an inadequately mobilized fundus from not taking down the short gastric vessels, or an unrecognized shortened esophagus (8). Fortunately, a repeat operation can correct both of these abnormalities, although redo operations are associated with increased morbidity and mortality of more than 1% (9). Postprandial bloating (gas-bloat syndrome) and excessive rectal gas occur in up to 45% of patients (2). These syndromes, which have been poorly studied, result from persistent air swallowing and the inability of the swallowed gas to escape by belching after a successful fundoplication. Symptoms tend to be less troublesome with an incomplete (Toupet) fundoplication compared with a full (Nissen) fundoplication (10), and they are usually self-limited and resolve in 1 to 3 months. Simple measures, such as avoiding carbonated beverages and smoking, and eating smaller meals with cessation of eating 0002-9343/03/$–see front matter 71 doi: 10.1016/S0002-9343(02)01389-X
The Truth About Laparoscopic Antireflux Surgery/Richter
when full, may help to ease this problem. More severe cases may mimic anginal chest pain or biliary colic and may suggest vagal nerve injury with secondary gastroparesis. Revision surgery is rarely required, but conversion to an incomplete fundoplication may be helpful (10). Klaus and colleagues (3) call our attention to the least commonly discussed postoperative complication— diarrhea—which has been reported in 25% to 33% of patients after laparoscopic antireflux surgery. Some of this diarrhea may be previously unrecognized irritable bowel syndrome, or, as the authors found in 15 patients (18% of their series) within 6 weeks of surgery, new-onset diarrhea. The diarrhea ranged from mild to debilitating, with 4 patients experiencing fecal incontinence. Most patients (13 of 15) were still experiencing diarrhea after 2 years, although only 6 required chronic antidiarrheal medication. The mechanisms of this diarrhea are poorly understood, although some cases are likely due to enhanced gastric emptying or inadvertent vagotomy. The durability of fundoplication for preventing the recurrence of reflux symptoms and the subsequent need for proton pump inhibitors are now just being understood. As I tell my patients: “It’s not like you are getting a new valve for your car.” Rather, the surgery is recreating the old lower esophageal sphincter by reducing the hiatal hernia back into the abdomen, closing the hiatus around the esophagus, and using the mobilized fundus to lengthen and buttress the new intra-abdominal sphincter. Over time, the wrap weakens, and symptomatic reflux sometimes recurs because of “abdominal stressors” that cause intermittent strain on the esophagogastric junction and the fundoplication. In the immediate perioperative period, this stressor is usually severe nausea and vomiting. More often, I have observed successful fundoplications, defined by no symptoms and normal 24-hour pH studies 3 months postoperatively, become dysfunctional with recurrent heartburn as a result of trauma to the chest (e.g., car accident, falling down stairs), heavy isometric exercises (e.g., weight lifting, more than 100 sit-ups daily), heavy lifting, excessive weight gain, bulimia, or paroxysms of severe coughing due to a drug reaction. Although difficult to discuss, all physicians involved with laparoscopic antireflux surgery must admit to their patients that the procedure may not be a “lifelong cure.” These limitations first came to our attention with reports on the follow-up to the original VA Cooperative Study on open antireflux surgery (11). In these older men with severe gastroesophageal reflex disease, 62% (23/37) used antireflux medications regularly, 32% were taking proton pump inhibitors, and 16% required at least another antireflux operation during the 10 years after surgery. More recently, surgeons at several academic centers have reported the recurrence of typical reflux symptoms and the use of proton pump inhibitors in up to 38% of patients 72
January 2003
THE AMERICAN JOURNAL OF MEDICINE威
Volume 114
after 2 to 3 years of surgical follow-up (12,13), which are similar to the rates reported by Vakil et al. (4). Of these latter patients (4), 32% (26/80) were taking heartburn medications regularly after an average follow-up period of 20 months; 16 were taking proton pump inhibitors, and 6 (7%) had undergone repeat surgery for postoperative complications. How should we manage our patients who have severe gastroesophageal reflux disease? At the Cleveland Clinic, all patients with severe disease are evaluated by both gastroenterologists and surgeons. Because large studies now show equal efficacy in treating patients with proton pump inhibitors or antireflux surgery (14), this debate adds little to the care of our patients. We use this opportunity instead to discuss the benefits and risks of both treatments, as well as unresolved long-term issues. No particular expertise is required for prescribing proton pump inhibitors. Morbidity associated with their use is rare; there has been no drug-related mortality; and their use has no irreversible consequences (15). However, many patients will require lifelong daily medications, which are expensive, and the long-term risks after 15 years are unknown. Surgery offers a unique opportunity to cure this disease, but success depends on a correct diagnosis and the experience of the surgeon. Disadvantages include frequent postoperative complications, the possibility of death, and the unknown long-term durability of antireflux surgery. The issue of surgical durability versus the long-term safety of medications is especially critical for young patients with chronic disease. We take the approach of openly discussing both options with our patients and allowing them to make informed decisions. This way, patients are proactive in their treatment, usually happy with the results, and not surprised, disappointed, or angry if complications or relapses occur.
REFERENCES 1. Dallemagne B, Weerts JM, Jehoes C, et al. Laparoscopic Nissen fundoplication: preliminary report. Surg Laparosc Endosc. 1991;1: 138 –143. 2. Carlson MA, Frantzides CT. Complications and results of primary minimally invasive antireflux procedures: a review of 10,735 reported cases. J Am Coll Surg. 2001;193:428 –439. 3. Klaus A, Hinder RA, DeVault KR, Achem SR. Bowel dysfunction after laparoscopic antireflux surgery: incidence, severity, and clinical course. Am J Med. 2003;114:1–5. 4. Vakil N, Shaw M, Kirby R. Clinical effectiveness of laparoscopic fundoplication in a U.S. community. Am J Med. 2003;114:000 –000. 5. Rantanen TK, Salo JA, Sipponen JT. Fatal and life-threatening complications in antireflux surgery: analysis of 5502 operations. Br J Surg. 1999;86:1573–1577. 6. Perdikis G, Hinder RA, Lund RJ, et al. Laparoscopic Nissen fundoplication: where do we stand? Surg Laparosc Endosc. 1997;7: 17–21. 7. Malhi-Chowla N, Gorecki P, Bammer T, et al. Dilation after fundoplication: timing, frequency, indications, and outcome. Gastrointest Endosc. 2002;55:219 –223.
The Truth About Laparoscopic Antireflux Surgery/Richter 8. Wo JM, Trus TL, Richardson WR, et al. Evaluation and management of post-fundoplication dysphagia. Am J Gastroenterol. 1996; 91:2318 –2322. 9. Rice TW. Why antireflux surgery fails. Dig Dis. 2000;18:43–47. 10. Rydlberg L, Ruth M, Lundell L. Mechanism of action of antireflux procedures. Br J Surg. 1999;86:405–410. 11. Spechler SJ, Lee E, Ahnen D, et al. Long-term outcome of medical and surgical therapies for gastroesophageal reflux disease. Follow-up of a randomized controlled trial. JAMA. 2001;285:2331– 2338. 12. Fernando HC, Luketich JD, Christie NA, et al. Outcome of laparo-
scopic Toupet compared to laparoscopic Nissen fundoplication. Surg Endosc. 2002;16:902–905. 13. Liu JY, Woloshin S, Laycock WS, Schwartz LM. Late outcome after laparoscopic surgery for gastroesophageal reflux. Arch Surg. 2002; 137:397–401. 14. Lundell L, Miettinen P, Myrvold AE, et al. Continued (5 year) follow-up of a randomized clinical study comparing antireflux surgery and omeprazole in gastroesophageal reflux disease. J Am Coll Surg. 2001;192:172–181. 15. Garnett WR. Consideration for long-term use of proton pump inhibitors. Am J Health Syst Pharm. 1998;55:2268 –2279.
January 2003
THE AMERICAN JOURNAL OF MEDICINE威
Volume 114 73
Let the Patient Beware: The Evolving Truth about Laparoscopic Antireflux Surgery Joel E. Richter, MD
S
ince its description in 1991 by Dallemagne et al. (1), laparoscopic antireflux surgery has grown in popularity as the treatment for severe gastroesophageal reflux disease. In a survey of U.S. hospitals by the National Center for Health Statistics, patient discharges with the International Classification of Diseases, Ninth Revision, Clinical Modification code 44.66 (“other procedures for creation of esophagogastric sphincter competence,” or fundoplication) were 13,000 in 1988, 22,000 in 1993, and 40,000 in 1998 (2). Much of this growth has come with the advent of the minimally invasive laparoscopic operation through the abdomen. However, now that five proton pump inhibitors are available, and omeprazole will soon be available over the counter at its prescription dose, more patients with gastroesophageal reflux disease are asking their family practitioner, internist, or gastroenterologist to help them choose the appropriate long-term treatment for their chronic disease. Two articles by Klaus et al. (3) and Vakil et al. (4) that appear in this month’s Journal give some perspective on the evolving truth about laparoscopic antireflux surgery. Despite marketing terms, such as “minimally invasive” or “keyhole surgery,” laparoscopic antireflux surgery is a fairly involved procedure. General anesthesia is required; most patients are hospitalized for at least 24 hours; and the 30-day surgical mortality ranges from 0.08% to 0.2% (2,5). Causes of death include missed esophageal, gastric, or duodenal perforations; ischemic bowel associated with mesenteric thrombosis; and myocardial infarctions. About 4% to 6% of patients experience immediate perioperative complications that delay their hospital discharge (2,6). The most common complication (1.3%) is early wrap herniation, usually from uncontrolled postprocedure nausea and vomiting, which frequently requires re-operation. Other complications include pneumothorax (1%), which is usually due to a pleural tear
Am J Med. ;114:71–73. From the Center for Swallowing and Esophageal Disorders, Department of Gastroenterology/Hepatology, Cleveland Clinic Foundation, Cleveland, Ohio. Requests for reprints should be addressed to Joel E. Richter, MD, Department of Gastroenterology/Hepatology, A30, Digestive Disease Center, 9500 Euclid Avenue, Cleveland Clinic Foundation, Cleveland, Ohio 44195, or [email protected]. Manuscript submitted August 6, 2002. ©2003 by Excerpta Medica Inc. All rights reserved.
during mediastinal dissection of the hiatal hernia; bowel perforation (0.78%); wound infection (0.11%); and splenectomy (0.06%). The likelihood of splenectomy in the laparoscopic procedure has dropped dramatically to about a hundredth of that reported for the open antireflux operation (2). Postoperative complications after laparoscopic antireflux surgery are common, may be prolonged, and may affect quality of life. A frank discussion of these complications is often overlooked in the enthusiasm to discuss the minimal postoperative abdominal pain from the small port incisions and the more rapid return to full activity and work. However, as emphasized by the authors of the two articles (3,4), complications, such as dysphagia, gas-bloat syndrome, increased flatus, and diarrhea, are common after surgery, with incidences ranging from 25% to 50%, at least in the short term (2– 6). Dysphagia during the early postoperative procedure is probably related to edema and inflammation; it is common, occurring in up to 50% of patients (7). The condition generally resolves in 2 to 3 months and can be managed with a soft-food diet and intermittent bougie dilation. In 3% to 24% of patients, it may persist from 6 months to 1 year (8). In such cases, careful endoscopic and radiographic testing often reveal evidence of an overly long wrap, or a “slipped” fundoplication, which is when the fundoplication has slipped down onto the stomach or up the esophagus onto the chest. The slipped fundoplication usually results from tension on the wrap caused by an inadequately mobilized fundus from not taking down the short gastric vessels, or an unrecognized shortened esophagus (8). Fortunately, a repeat operation can correct both of these abnormalities, although redo operations are associated with increased morbidity and mortality of more than 1% (9). Postprandial bloating (gas-bloat syndrome) and excessive rectal gas occur in up to 45% of patients (2). These syndromes, which have been poorly studied, result from persistent air swallowing and the inability of the swallowed gas to escape by belching after a successful fundoplication. Symptoms tend to be less troublesome with an incomplete (Toupet) fundoplication compared with a full (Nissen) fundoplication (10), and they are usually self-limited and resolve in 1 to 3 months. Simple measures, such as avoiding carbonated beverages and smoking, and eating smaller meals with cessation of eating 0002-9343/03/$–see front matter 71 doi: 10.1016/S0002-9343(02)01389-X
The Truth About Laparoscopic Antireflux Surgery/Richter
when full, may help to ease this problem. More severe cases may mimic anginal chest pain or biliary colic and may suggest vagal nerve injury with secondary gastroparesis. Revision surgery is rarely required, but conversion to an incomplete fundoplication may be helpful (10). Klaus and colleagues (3) call our attention to the least commonly discussed postoperative complication— diarrhea—which has been reported in 25% to 33% of patients after laparoscopic antireflux surgery. Some of this diarrhea may be previously unrecognized irritable bowel syndrome, or, as the authors found in 15 patients (18% of their series) within 6 weeks of surgery, new-onset diarrhea. The diarrhea ranged from mild to debilitating, with 4 patients experiencing fecal incontinence. Most patients (13 of 15) were still experiencing diarrhea after 2 years, although only 6 required chronic antidiarrheal medication. The mechanisms of this diarrhea are poorly understood, although some cases are likely due to enhanced gastric emptying or inadvertent vagotomy. The durability of fundoplication for preventing the recurrence of reflux symptoms and the subsequent need for proton pump inhibitors are now just being understood. As I tell my patients: “It’s not like you are getting a new valve for your car.” Rather, the surgery is recreating the old lower esophageal sphincter by reducing the hiatal hernia back into the abdomen, closing the hiatus around the esophagus, and using the mobilized fundus to lengthen and buttress the new intra-abdominal sphincter. Over time, the wrap weakens, and symptomatic reflux sometimes recurs because of “abdominal stressors” that cause intermittent strain on the esophagogastric junction and the fundoplication. In the immediate perioperative period, this stressor is usually severe nausea and vomiting. More often, I have observed successful fundoplications, defined by no symptoms and normal 24-hour pH studies 3 months postoperatively, become dysfunctional with recurrent heartburn as a result of trauma to the chest (e.g., car accident, falling down stairs), heavy isometric exercises (e.g., weight lifting, more than 100 sit-ups daily), heavy lifting, excessive weight gain, bulimia, or paroxysms of severe coughing due to a drug reaction. Although difficult to discuss, all physicians involved with laparoscopic antireflux surgery must admit to their patients that the procedure may not be a “lifelong cure.” These limitations first came to our attention with reports on the follow-up to the original VA Cooperative Study on open antireflux surgery (11). In these older men with severe gastroesophageal reflex disease, 62% (23/37) used antireflux medications regularly, 32% were taking proton pump inhibitors, and 16% required at least another antireflux operation during the 10 years after surgery. More recently, surgeons at several academic centers have reported the recurrence of typical reflux symptoms and the use of proton pump inhibitors in up to 38% of patients 72
January 2003
THE AMERICAN JOURNAL OF MEDICINE威
Volume 114
after 2 to 3 years of surgical follow-up (12,13), which are similar to the rates reported by Vakil et al. (4). Of these latter patients (4), 32% (26/80) were taking heartburn medications regularly after an average follow-up period of 20 months; 16 were taking proton pump inhibitors, and 6 (7%) had undergone repeat surgery for postoperative complications. How should we manage our patients who have severe gastroesophageal reflux disease? At the Cleveland Clinic, all patients with severe disease are evaluated by both gastroenterologists and surgeons. Because large studies now show equal efficacy in treating patients with proton pump inhibitors or antireflux surgery (14), this debate adds little to the care of our patients. We use this opportunity instead to discuss the benefits and risks of both treatments, as well as unresolved long-term issues. No particular expertise is required for prescribing proton pump inhibitors. Morbidity associated with their use is rare; there has been no drug-related mortality; and their use has no irreversible consequences (15). However, many patients will require lifelong daily medications, which are expensive, and the long-term risks after 15 years are unknown. Surgery offers a unique opportunity to cure this disease, but success depends on a correct diagnosis and the experience of the surgeon. Disadvantages include frequent postoperative complications, the possibility of death, and the unknown long-term durability of antireflux surgery. The issue of surgical durability versus the long-term safety of medications is especially critical for young patients with chronic disease. We take the approach of openly discussing both options with our patients and allowing them to make informed decisions. This way, patients are proactive in their treatment, usually happy with the results, and not surprised, disappointed, or angry if complications or relapses occur.
REFERENCES 1. Dallemagne B, Weerts JM, Jehoes C, et al. Laparoscopic Nissen fundoplication: preliminary report. Surg Laparosc Endosc. 1991;1: 138 –143. 2. Carlson MA, Frantzides CT. Complications and results of primary minimally invasive antireflux procedures: a review of 10,735 reported cases. J Am Coll Surg. 2001;193:428 –439. 3. Klaus A, Hinder RA, DeVault KR, Achem SR. Bowel dysfunction after laparoscopic antireflux surgery: incidence, severity, and clinical course. Am J Med. 2003;114:1–5. 4. Vakil N, Shaw M, Kirby R. Clinical effectiveness of laparoscopic fundoplication in a U.S. community. Am J Med. 2003;114:000 –000. 5. Rantanen TK, Salo JA, Sipponen JT. Fatal and life-threatening complications in antireflux surgery: analysis of 5502 operations. Br J Surg. 1999;86:1573–1577. 6. Perdikis G, Hinder RA, Lund RJ, et al. Laparoscopic Nissen fundoplication: where do we stand? Surg Laparosc Endosc. 1997;7: 17–21. 7. Malhi-Chowla N, Gorecki P, Bammer T, et al. Dilation after fundoplication: timing, frequency, indications, and outcome. Gastrointest Endosc. 2002;55:219 –223.
The Truth About Laparoscopic Antireflux Surgery/Richter 8. Wo JM, Trus TL, Richardson WR, et al. Evaluation and management of post-fundoplication dysphagia. Am J Gastroenterol. 1996; 91:2318 –2322. 9. Rice TW. Why antireflux surgery fails. Dig Dis. 2000;18:43–47. 10. Rydlberg L, Ruth M, Lundell L. Mechanism of action of antireflux procedures. Br J Surg. 1999;86:405–410. 11. Spechler SJ, Lee E, Ahnen D, et al. Long-term outcome of medical and surgical therapies for gastroesophageal reflux disease. Follow-up of a randomized controlled trial. JAMA. 2001;285:2331– 2338. 12. Fernando HC, Luketich JD, Christie NA, et al. Outcome of laparo-
scopic Toupet compared to laparoscopic Nissen fundoplication. Surg Endosc. 2002;16:902–905. 13. Liu JY, Woloshin S, Laycock WS, Schwartz LM. Late outcome after laparoscopic surgery for gastroesophageal reflux. Arch Surg. 2002; 137:397–401. 14. Lundell L, Miettinen P, Myrvold AE, et al. Continued (5 year) follow-up of a randomized clinical study comparing antireflux surgery and omeprazole in gastroesophageal reflux disease. J Am Coll Surg. 2001;192:172–181. 15. Garnett WR. Consideration for long-term use of proton pump inhibitors. Am J Health Syst Pharm. 1998;55:2268 –2279.
January 2003
THE AMERICAN JOURNAL OF MEDICINE威
Volume 114 73