- Email: [email protected]
Concerns with an Ethanol Protocol to Prevent Alcohol Withdrawal Symptoms
190
3.
4. 5. 6. 7.
Letters
site infections in the 1990s: attributable mortality, excess length of hospitalization, and extra costs. Infect Control Hosp Epidemiol 1999;20:725–730. Bratzler DW, Hunt DR. The surgical infection prevention and surgical care improvement projects: national initiatives to improve outcomes for patients having surgery. Clin Infect Dis 2006; 43:322–330. ACOG practice bulletin number 47, October 2003: prophylactic antibiotics in labor and delivery. Obstet Gynecol 2003;102:875– 882. Abramowicz M. Antimicrobial prophylaxis for surgery. Medical Letter 2004;2:27–32. ASHP Therapeutic Guidelines on Antimicrobial Prophylaxis in Surgery. American Society of Health-System Pharmacists. Am J Health Syst Pharm 1999;56:1839–1888. Bratzler DW, Houck PM. Antimicrobial prophylaxis for surgery: an advisory statement from the National Surgical Infection Prevention Project. Clin Infect Dis 2004;38:1706–1715.
Concerns with an Ethanol Protocol to Prevent Alcohol Withdrawal Symptoms Jennifer L McLaren, MD Jonathan C Schwartz, MD Lebanon, NH We have read with great interest the article by Dissanaike and colleagues.1 We are concerned that the practice of using ethanol drips in the treatment of alcohol withdrawal could be a potentially dangerous and unsafe practice. There are good data that other alternative treatments for alcohol withdrawal are both safe and effective. The authors’ primary rationale for using intravenous ethanol is its “lack of sedation at therapeutic doses.”1 Unfortunately, there is no published evidence showing that ethanol is either more or less sedating than benzodiazepines. Specifically, there have been no randomized controlled trials comparing the sedative effects of IV ethanol versus benzodiazepines. Benzodiazepines and ethanol work at the GABA receptors, to exert their sedative action. As the two agents work on the same receptor, there is no inherent reason to believe that benzodiazepines have a more sedating effect at therapeutic doses than ethanol. The authors further state that benzodiazepines “pose a risk of excess sedation, particularly among the elderly and those with liver disease.”1 It is well known that hepatic oxidative metabolism is decreased in persons with liver disease and the elderly.2-4 Ethanol is metabolized by hepatic oxidation.2-4 Infusion of ethanol in the elderly and patients with liver disease can lead to an accumulation of the sub-
J Am Coll Surg
stance and cause excessive sedation and respiratory depression. Metabolism and excretion of benzodiazepines such as lorazepam and oxazepam do not rely on hepatic oxidation and therefore are minimally affected by liver dysfunction.2-5 These medications undergo hepatic glucoronidation, which is preserved until the very end stages of liver disease. Thus, lorazepam and oxazepam have less sedation than intravenous ethanol and should be the empiric choice for alcohol withdrawal symptoms in the elderly and in patients with liver disease.2 Intravenous ethanol has a narrow therapeutic window and leaves patients at risk for ethanol toxicity.6,7 This is especially true for the elderly and those with impaired liver function, where other unmeasurable breakdown products of alcohol can build up.3 It is well established that there is tremendous variability in the kinetics of alcohol metabolism, and this is especially true for the chronic alcohol user.8 Some hospitals do not have the ability to rapidly obtain blood alcohol contents. We have seen one case where a patient on an alcohol drip became clinically intoxicated despite a negative blood alcohol level, possibly because of a delay in assaying his blood. Even with adequate laboratory facilities, we are concerned about the authors’ suggestion of checking blood alcohol content just 3 times over the proposed 72-hour treatment period, as this relatively infrequent monitoring could leave patients at a high risk for toxicity. In conclusion, we believe benzodiazepines are a safer alternative to intravenous ethanol for the treatment of alcohol withdrawal syndrome. We are in favor of a standardized, symptom-triggered approach to alcohol withdrawal using benzodiazepines, which has been shown to be safe in surgical patients.9
REFERENCES 1. Dissanaike S, Halldorsson A, Frezza E, et al. An ethanol protocol to prevent alcohol withdrawal syndrome. J Am Coll Surg 2006; 203:186–191. 2. Peppers MP. Benzodiazepines for alcohol withdrawal in the elderly and in patients with liver disease. Pharmacotherapy 1996; 16:49–57. 3. Bhopale KK, Wu H, Boor PJ, et al. Metabolic basis of ethanolinduced hepatic and pancreatic injury in hepatic alcohol dehydrogenase deficient deer mice. Alcohol 2006;39:179–188. 4. Greenblatt DJ, Harmatz JS, Shader RI. Clinical pharmacokinetics of anxiolytics and hypnotics in the elderly. Therapeutic considerations (Part I). Clin Pharmacokinet 1991;21:165–177. 5. Greenblatt DJ. Clinical pharmacokinetics of oxazepam and lorazepam. Clin Pharmacokinet 1981;6:89–105. 6. Mayo-Smith MF, Cushman P Jr, Hill AJ, et al. Pharmacological management of alcohol withdrawal. A meta-analysis and evidence-based practice guideline. JAMA 1997;278:144–151.
Vol. 205, No. 1, July 2007
7. Golbert TM, Sanz CJ, Rose HD, et al. Comparative evaluation of treatments of alcohol withdrawal syndromes. JAMA 1967;201: 99–102. 8. Wilkens L, Ruschulte H, Ruckoldt H, et al. Standard calculation of ethanol elimination rate is not sufficient to provide ethanol substitution therapy in the postoperative course of alcoholdependent patients. Intensive Care Med 1998;24:459–463. 9. Stanley KM, Amabile CM, Simpson KN, et al. Impact of an alcohol withdrawal syndrome practice guideline on surgical patient outcomes. Pharmacotherapy 2003;23:843–854.
Stapled Transanal Rectal Resection Procedure William A Bernie, MD, FACS Cincinnati, OH We have reviewed the recent article, by Arroyo and colleagues,1 and these authors are to be recognized for their efforts to document their experiences with a new surgical procedure in the therapy of obstructed defecation syndrome. This condition has been recognized as a chronic life-changing issue for many women, and the development of the STARR procedure appears to give significant relief to selected women. In this study the authors report on a trial comparing two Ethicon Endo-Surgery, Inc, circular stapling devices, the PPH01 Hemorrhoidal Circular Stapler and the PPH03 PROXIMATE PPH Procedure for Prolapse and Hemorrhoids Set. The PPH03 devices are being used off label. Use of the device on the full-thickness rectal wall, and use in the Stapled Transanal Rectal Resection (STARR) procedure, is specifically contraindicated in the product insert. The PPH03 device is specifically indicated only for the surgical treatment of hemorrhoidal disease. Because the device is designed to improve hemostasis by increasing tissue compression by means of a lower staple height, there was improved hemostasis when using the PPH03 device. There is an increased risk of device failure when using this device in full-thickness rectal wall resection and in the STARR procedure. Such use may result in failure of the device to form staples, along with partial cutting of the rectal wall. In addition, even if the device seems to function normally, inadequate staple formation may occur. This may not be immediately recognized and could lead to staple line leaks or disruption in the postoperative period. If this occurs, it is not a device malfunction but rather an error in device usage. In the review of articles such as this, is it reasonable for the editors to comment about off-label device usage? I
Letters
191
would appreciate any comments or suggestions about this matter. REFERENCE 1. Arroyo A, Pérez-Vicente F, Serrano P, et al. Evaluation of the stapled transanal rectal resection technique with two staplers in the treatment of obstructed defecation syndrome. J Am Coll Surg 2007;204:56–63.
Reply Antonio Arroyo, PhD Alicante, Spain Certainly, the use of a PPH03 device for stapled transanal rectal resection (STARR) procedures is formally contraindicated in the product insert. But just as explained in our report,1 the PPH33-01 stapler was put aside from circulation in Spain in February 2004, and was not available any more. For this reason, the use of the PPH33-03 stapler was authorized for the treatment of conditions such as mucosal or rectal prolapse, rectocele, anal fistula, and hemorrhoids.1-4 Despite the greater amount of tissue pulled into the cartridge of the stapler, the thickness of the rectal wall at the level of the stapled line is comparable with that obtained in the conventional stapled mucosectomy for prolapsed hemorrhoids, involving mucosa, submucosa, and part of the rectal muscular wall. The result is quite a secure and tension-free anastomosis, with adequate vascularization, minimizing the risk of device failure. There is a national data-bank in Spain with 45 patients operated on for symptomatic rectocoele with the PPH-33 to -03 stapler and no important incidents have been reported to date. We have also reported a technical modification of the PPH-33 procedure for prolapsed hemorrhoids, consisting of a double purse-string fashioned 1.5 cm above the first one, aimed at resecting a greater doughnut, theorically avoiding residual prolapse, and we have not noticed any adverse effect in terms of anastomotic failure.2,3
REFERENCES 1. Arroyo A, Perez-Vicente F, Serrano P, et al. Evaluation of the stapled transanal rectal resection technique with two staplers in the treatment of obstructive defecation syndrome. J Am Coll Surg 2007;204:56–63. 2. Arroyo A, Pérez F, Miranda E, et al. Prospective randomized clinical trial comparing two different circular staplers for mucosectomy in the treatment of haemorrhoids. World J Surg 2006; 30:1305–1310.
3.
4. 5. 6. 7.
Letters
site infections in the 1990s: attributable mortality, excess length of hospitalization, and extra costs. Infect Control Hosp Epidemiol 1999;20:725–730. Bratzler DW, Hunt DR. The surgical infection prevention and surgical care improvement projects: national initiatives to improve outcomes for patients having surgery. Clin Infect Dis 2006; 43:322–330. ACOG practice bulletin number 47, October 2003: prophylactic antibiotics in labor and delivery. Obstet Gynecol 2003;102:875– 882. Abramowicz M. Antimicrobial prophylaxis for surgery. Medical Letter 2004;2:27–32. ASHP Therapeutic Guidelines on Antimicrobial Prophylaxis in Surgery. American Society of Health-System Pharmacists. Am J Health Syst Pharm 1999;56:1839–1888. Bratzler DW, Houck PM. Antimicrobial prophylaxis for surgery: an advisory statement from the National Surgical Infection Prevention Project. Clin Infect Dis 2004;38:1706–1715.
Concerns with an Ethanol Protocol to Prevent Alcohol Withdrawal Symptoms Jennifer L McLaren, MD Jonathan C Schwartz, MD Lebanon, NH We have read with great interest the article by Dissanaike and colleagues.1 We are concerned that the practice of using ethanol drips in the treatment of alcohol withdrawal could be a potentially dangerous and unsafe practice. There are good data that other alternative treatments for alcohol withdrawal are both safe and effective. The authors’ primary rationale for using intravenous ethanol is its “lack of sedation at therapeutic doses.”1 Unfortunately, there is no published evidence showing that ethanol is either more or less sedating than benzodiazepines. Specifically, there have been no randomized controlled trials comparing the sedative effects of IV ethanol versus benzodiazepines. Benzodiazepines and ethanol work at the GABA receptors, to exert their sedative action. As the two agents work on the same receptor, there is no inherent reason to believe that benzodiazepines have a more sedating effect at therapeutic doses than ethanol. The authors further state that benzodiazepines “pose a risk of excess sedation, particularly among the elderly and those with liver disease.”1 It is well known that hepatic oxidative metabolism is decreased in persons with liver disease and the elderly.2-4 Ethanol is metabolized by hepatic oxidation.2-4 Infusion of ethanol in the elderly and patients with liver disease can lead to an accumulation of the sub-
J Am Coll Surg
stance and cause excessive sedation and respiratory depression. Metabolism and excretion of benzodiazepines such as lorazepam and oxazepam do not rely on hepatic oxidation and therefore are minimally affected by liver dysfunction.2-5 These medications undergo hepatic glucoronidation, which is preserved until the very end stages of liver disease. Thus, lorazepam and oxazepam have less sedation than intravenous ethanol and should be the empiric choice for alcohol withdrawal symptoms in the elderly and in patients with liver disease.2 Intravenous ethanol has a narrow therapeutic window and leaves patients at risk for ethanol toxicity.6,7 This is especially true for the elderly and those with impaired liver function, where other unmeasurable breakdown products of alcohol can build up.3 It is well established that there is tremendous variability in the kinetics of alcohol metabolism, and this is especially true for the chronic alcohol user.8 Some hospitals do not have the ability to rapidly obtain blood alcohol contents. We have seen one case where a patient on an alcohol drip became clinically intoxicated despite a negative blood alcohol level, possibly because of a delay in assaying his blood. Even with adequate laboratory facilities, we are concerned about the authors’ suggestion of checking blood alcohol content just 3 times over the proposed 72-hour treatment period, as this relatively infrequent monitoring could leave patients at a high risk for toxicity. In conclusion, we believe benzodiazepines are a safer alternative to intravenous ethanol for the treatment of alcohol withdrawal syndrome. We are in favor of a standardized, symptom-triggered approach to alcohol withdrawal using benzodiazepines, which has been shown to be safe in surgical patients.9
REFERENCES 1. Dissanaike S, Halldorsson A, Frezza E, et al. An ethanol protocol to prevent alcohol withdrawal syndrome. J Am Coll Surg 2006; 203:186–191. 2. Peppers MP. Benzodiazepines for alcohol withdrawal in the elderly and in patients with liver disease. Pharmacotherapy 1996; 16:49–57. 3. Bhopale KK, Wu H, Boor PJ, et al. Metabolic basis of ethanolinduced hepatic and pancreatic injury in hepatic alcohol dehydrogenase deficient deer mice. Alcohol 2006;39:179–188. 4. Greenblatt DJ, Harmatz JS, Shader RI. Clinical pharmacokinetics of anxiolytics and hypnotics in the elderly. Therapeutic considerations (Part I). Clin Pharmacokinet 1991;21:165–177. 5. Greenblatt DJ. Clinical pharmacokinetics of oxazepam and lorazepam. Clin Pharmacokinet 1981;6:89–105. 6. Mayo-Smith MF, Cushman P Jr, Hill AJ, et al. Pharmacological management of alcohol withdrawal. A meta-analysis and evidence-based practice guideline. JAMA 1997;278:144–151.
Vol. 205, No. 1, July 2007
7. Golbert TM, Sanz CJ, Rose HD, et al. Comparative evaluation of treatments of alcohol withdrawal syndromes. JAMA 1967;201: 99–102. 8. Wilkens L, Ruschulte H, Ruckoldt H, et al. Standard calculation of ethanol elimination rate is not sufficient to provide ethanol substitution therapy in the postoperative course of alcoholdependent patients. Intensive Care Med 1998;24:459–463. 9. Stanley KM, Amabile CM, Simpson KN, et al. Impact of an alcohol withdrawal syndrome practice guideline on surgical patient outcomes. Pharmacotherapy 2003;23:843–854.
Stapled Transanal Rectal Resection Procedure William A Bernie, MD, FACS Cincinnati, OH We have reviewed the recent article, by Arroyo and colleagues,1 and these authors are to be recognized for their efforts to document their experiences with a new surgical procedure in the therapy of obstructed defecation syndrome. This condition has been recognized as a chronic life-changing issue for many women, and the development of the STARR procedure appears to give significant relief to selected women. In this study the authors report on a trial comparing two Ethicon Endo-Surgery, Inc, circular stapling devices, the PPH01 Hemorrhoidal Circular Stapler and the PPH03 PROXIMATE PPH Procedure for Prolapse and Hemorrhoids Set. The PPH03 devices are being used off label. Use of the device on the full-thickness rectal wall, and use in the Stapled Transanal Rectal Resection (STARR) procedure, is specifically contraindicated in the product insert. The PPH03 device is specifically indicated only for the surgical treatment of hemorrhoidal disease. Because the device is designed to improve hemostasis by increasing tissue compression by means of a lower staple height, there was improved hemostasis when using the PPH03 device. There is an increased risk of device failure when using this device in full-thickness rectal wall resection and in the STARR procedure. Such use may result in failure of the device to form staples, along with partial cutting of the rectal wall. In addition, even if the device seems to function normally, inadequate staple formation may occur. This may not be immediately recognized and could lead to staple line leaks or disruption in the postoperative period. If this occurs, it is not a device malfunction but rather an error in device usage. In the review of articles such as this, is it reasonable for the editors to comment about off-label device usage? I
Letters
191
would appreciate any comments or suggestions about this matter. REFERENCE 1. Arroyo A, Pérez-Vicente F, Serrano P, et al. Evaluation of the stapled transanal rectal resection technique with two staplers in the treatment of obstructed defecation syndrome. J Am Coll Surg 2007;204:56–63.
Reply Antonio Arroyo, PhD Alicante, Spain Certainly, the use of a PPH03 device for stapled transanal rectal resection (STARR) procedures is formally contraindicated in the product insert. But just as explained in our report,1 the PPH33-01 stapler was put aside from circulation in Spain in February 2004, and was not available any more. For this reason, the use of the PPH33-03 stapler was authorized for the treatment of conditions such as mucosal or rectal prolapse, rectocele, anal fistula, and hemorrhoids.1-4 Despite the greater amount of tissue pulled into the cartridge of the stapler, the thickness of the rectal wall at the level of the stapled line is comparable with that obtained in the conventional stapled mucosectomy for prolapsed hemorrhoids, involving mucosa, submucosa, and part of the rectal muscular wall. The result is quite a secure and tension-free anastomosis, with adequate vascularization, minimizing the risk of device failure. There is a national data-bank in Spain with 45 patients operated on for symptomatic rectocoele with the PPH-33 to -03 stapler and no important incidents have been reported to date. We have also reported a technical modification of the PPH-33 procedure for prolapsed hemorrhoids, consisting of a double purse-string fashioned 1.5 cm above the first one, aimed at resecting a greater doughnut, theorically avoiding residual prolapse, and we have not noticed any adverse effect in terms of anastomotic failure.2,3
REFERENCES 1. Arroyo A, Perez-Vicente F, Serrano P, et al. Evaluation of the stapled transanal rectal resection technique with two staplers in the treatment of obstructive defecation syndrome. J Am Coll Surg 2007;204:56–63. 2. Arroyo A, Pérez F, Miranda E, et al. Prospective randomized clinical trial comparing two different circular staplers for mucosectomy in the treatment of haemorrhoids. World J Surg 2006; 30:1305–1310.