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The safety and cost-effectiveness of polyethylene glycol electrolyte solution bowel preparation in infants and children
The Safety and Cost-Effectiveness of Polyethylene Glycol Electrolyte Solution Bowel Preparation in Infants and Children By David W. Tuggle, Dennis J. Hoelzer, William P. Tunell, and E. Ide Smith Oklahoma City, Oklahoma 9 Golytely, a polyethylene glycol electrolyte solution (Braintree Laboratories, Braintree, MA), was evaluated in the preoperative bowel preparation of 21 infants and children. Weight, temperature, pulse, respiratory rate, and electrolyte concentrations w e r e documented before and after mechanical bowel preparation. All children w e r e given 25 m L / k g / h of Golytely until rectal effluent was clear and free of particulate matter. All preparations w e r e started and completed the afternoon prior to surgery. Weight, vital signs, and electrolyte concentrations did not change significantly. All preparations w e r e felt to be fair or excellent. Follow-up for 1 month postoperatively revealed no infectious complications. Golytely is safe and effective in preparing the bowel prior to surgery in children. Using Golytely can eliminate the need for multiple-day hospitalizations for bowel preparation and thus decrease the cost of medical care, 9 1987 by Grune & Stratton, Inc. INDEX WORDS: Bowel preparation for surgery; Golytely.
ECHANICAL CLEANSING of the bowel is
an essential component of preoperative bowel M preparation. A typical mechanical bowel preparation is started two or three days prior to surgery and consists of a clear liquid diet and concomitant enemas and cathartics. Vigorous bowel cleansing of this sort may produce hypovolemia and electrolyte disturbances. Such preparation may require two days of hospitalization prior to surgery to insure compliance and is poorly accepted by patients. Recent adult studies 13 have demonstrated the safety and effectiveness of whole gut irrigation with a polyethylene glycol electrolyte solution, Golytely (Braintree Laboratories, Braintree, MA). The superiority of Golytely as a bowel cleansing agent in children prior to colonoscopy has been documented. 4 Gut irrigation with Golytely to prepare the bowel prior to intestinal surgery has not been reported in children.
immediately before and after bowel preparation. Thirteen patients had electrolyte determinations before and after bowel irrigation. The remaining patients underwent electrolyte determinations only after bowel preparation. The preparation was categorized by the attending surgeons as excellent, fair, or poor at the time of operation and recorded. An excellent preparation was free of particulate matter and fluid. A fair preparation had minimal particulate matter or a moderate amount of liquid stool, and a poor preparation had any solid feces. Follow-up for infectious complications was continued for 1 month postoperatively. A Student's t-test was used for statistical comparison. Values are expressed as mean and standard error of the mean.
RESULTS
Twelve males and nine females underwent Golytely bowel preparation for a variety of indications; colostomy closure (11), Hirschprung's disease (5), esophageal replacement (2), total colectomy and mucosal protectomy (2), and diverting colostomy (l). There were 11 patients < l year of age, seven children 1 to 5 years of age, and three children older than 5 years (average age 27.9 months, range 3 weeks to 14 years). The average weight was 11,8 _+2.9 kg. The mean duration of bowel preparation was 4 _+0.2 hours. Golytely delivery was accomplished by nasogastric tube in 14 patients, gastrostomy tube in three patients, and by mouth in four patients. Nasogastric tube position was confirmed by a physician in every patient. All patients completed their preparation without alteration of their calculated hourly requirements (25 mL/kg/h). Twenty patients tolerated the preparation well. One patient developed vomiting during bowel preparation. Metoclopramide, 0.1 mg/kg was given orally, and the preparation was continued successfully without further nausea or vomiting. Table 1 reflects the vital signs of the children before and after bowel preparation. Temperature, weight, heart rate, and respiratory rate decreased slightly. These changes were not statistically significant. Serum
MATERIALS AND METHODS Twenty-one patients required mechanical bowel preparation prior to surgery. All patients were allowed to eat ad lib until the day prior to surgery, when they were begun on a clear liquid diet. During the afternoon and evening, Golytely was given by mouth, nasogastric tube, or gastrostomy tube at a rate of 25 m L / k g / h for three to seven hours. To monitor tolerance to the preparation, infants were observed every 15 minutes during Golytely administration, while older children were checked hourly. Golytely was administered until the rectal effluent was clear and free of particulate matter. Enteral and parenteral antibiotics were used as an adjunct in these patients. Heart rate, respiratory rate, weight, and temperature were recorded
Journal of Pediatric Surgery, Vol 22, No 6 (June), 1987: pp 513-515
From the Department of Surgery, Section of Pediatric Surgery, University of Oklahoma College of Medicine, and the Oklahoma Children's Memorial Hospital, Oklahoma City, OK. Presented at the 35th Annual Meeting of the Surgical Section of the American Academy of Pediatrics, Washington, DC, November 1-2, 1986. Address reprint requests to David W. Tuggle, MD, Pediatric Surgery, PO Box 26307, Oklahoma City, OK 73126. 9 1987 by Grune & Stratton, Inc. 0022-3468/87/2206-0010503.00/0 513
514
TUGGLE ET AL
Table 1. Changes in Weight and Vital Signs After Golytely Preparation Temperature
Weight (kg)
(degrees C)
Heart Rate (beats/min)
RespiratoryRate (breaths/rain)
Before Golytely
11.8 • 2.9
3 6 . 7 _+ .07
126.7 _+ 5.2
3 2 _+ 2 . 8
After Golytely
11.8 • 2.8
3 6 . 6 • 0,1
123.9 +_ 6.1
3 0 + 2.1
Values expressed as mean • SEM.
electrolyte concentrations before and after Golytely preparation are shown in Table 2. No significant electrolyte changes were documented. The bowel preparation was judged intraoperatively by the attending surgeons and categorized as excellent, fair, or poor. Eighteen patients had excellent preparations, three had fair preparations, and none were judged to be poor. No postoperative wound or abdominal infection occurred in these patients. Our routine previously had been admission two days prior to surgery for bowel preparation. Sixteen patients in this series were admitted the day prior to surgery for preparation, thus reducing their hospital stay by one day and yielding an approximate savings of $350 per patient. DISCUSSION
Since first being introduced by Davis et al in 1980, 5 Golytely has rapidly become the fluid of choice for whole gut irrigation in many centers. ~6 Adult studies have shown that Golytely bowel cleansing is preferred over the standard three-day bowel preparation because it allows dietary freedom, short preparation time, and virtually eliminates enemasJ Goldman and associates 3 confirmed these findings and documented the safety of gut irrigation in patients with cardiac, renal, and pulmonary disease. Golytely has been shown effective in children as a preparation for colonoscopy.4 Our study demonstrates that Golytely can be safely used as a preoperative bowel preparation in children. Golytely contains 125 mmol/L of sodium, 40 mmol/ L of sulfate, 35 mmol/L of chloride, 20 mmol/L of bicarbonate, 10 mmol/L of potassium, and 17.6 mmol/L of polyethylene glycol. Polyethylene glycol 3350 is added as an osmotic agent to eliminate water absorption or secretion. It is not absorbed by normal intestinal mucosa and will not generate hydrogen when incubated with bacteria as mannitol does, thus decreasing the potential for bowel distention. The Table 2. Changes in Electrolytes After Golytely Bowel Preparation BeforeGolytely
After Golytely 139 + 1
Na(mg/L)
138_+ 1
K (mEq/L)
5.3 + 0.2
5.2 _+ 0 . 2
CI (mEq/L)
105 + 1.4
104 • 1.2
2 1 . 2 _+ 1.0
2 1 . 5 • 1.2
CO 2 (mEq/L)
Values expressed as mean _+ SEM.
electrolyte constituents of Golytely (particularly sulfate) were chosen because they cause no net electrolyte absorption or secretion when perfused through bowel segments. 5 The lack of significant changes in electrolyte concentration, weight, or vital signs after preparation support this data from adult studies. Even though more than half of our patients were under 1 year of age, our experience indicates that no significant change in weight, temperature, or electrolytes occurred in these smaller patients despite relatively large volumes of gut perfusate, further indicating the safety of this form of bowel preparation. Although no infectious complications occurred in any of our patients, we cannot reach any conclusions about the superiority of Golytely as a bowel preparation in reducing infections. Oral kanamycin or neomycin-erythromycin were each used in half of the patients while intravenous ampicillin and gentamicin were given perioperatively in all patients. Previous studies have demonstrated a significant decrease in colonic anaerobic bacteria after Golytely whole gut irrigation when compared with a traditional bowel preparation. 6 Aerobic growth remained similar, suggesting that a Golytely bowel preparation may be superior to the traditional method in eliminating colonic bacteria. When starting the clinical use of Golytely, we felt that no child would accept Golytely by mouth, because it has a slightly saltly bland taste. Therefore, most of our patients received their lavage by nasogastric or gastrostomy tube. However, a few children accepted the entire hourly amount by mouth and never required nasogastric intubation. If a nasogastric tube is required for Golytely delivery, its position should be confirmed by a physician and patients monitored closely during the preparation. The use of flavoring is discouraged because it may allow the production of luminal hydrogen, increasing the risk of distention, or change the concentration of electrolytes, allowing water or salt absorption or secretion. REFERENCES
1. ThomasG, BrozinskyS, EisenbergJ: Patient acceptanceand effectiveness of a balanced lavage solution (Golytely)versus the standard preparationfor colonoscopy.Gastroenterology82:435-437, 1982 2. ErnstoffJ J, Howard DA, Marshall JB, et al: A randomized blinded clinical trial of a rapid coloniclavage solution (Golytely) compared with standard preparation for colonoscopyand barium enema. Gastroenterology84:1512-1516, 1983
BOWEL PREPARATION IN CHILDREN
3. Goldman J, Reichelderfer M: Evaluation of a rapid colonoscopy preparation using a new gut lavage solution. Gastrointest Endosc 28:9-11, 1982 4. Tolia V, Fleming S, DuBois RS: Use of Golytely in children and adolescents. J Pediatr Gastroenterol Nutr 3:468-470, 1984 5. Davis G, Santa Ana C, Morawski S, et al: Development of a
515
lavage solution associated with minimal water and electrolyte absorption and secretion. Gastroeneterology 78:991-995, 1980 6. Fleites RA, Marshall JB, Eckhauser ML, et al: The efficacy of polyethylene glycol-electrolyte lavage solution versus traditional mechanical bowel preparation for elective colonic surgery: A randomized prospective blinded clinical trial. Surgery 98:708-716, 1985
ECHANICAL CLEANSING of the bowel is
an essential component of preoperative bowel M preparation. A typical mechanical bowel preparation is started two or three days prior to surgery and consists of a clear liquid diet and concomitant enemas and cathartics. Vigorous bowel cleansing of this sort may produce hypovolemia and electrolyte disturbances. Such preparation may require two days of hospitalization prior to surgery to insure compliance and is poorly accepted by patients. Recent adult studies 13 have demonstrated the safety and effectiveness of whole gut irrigation with a polyethylene glycol electrolyte solution, Golytely (Braintree Laboratories, Braintree, MA). The superiority of Golytely as a bowel cleansing agent in children prior to colonoscopy has been documented. 4 Gut irrigation with Golytely to prepare the bowel prior to intestinal surgery has not been reported in children.
immediately before and after bowel preparation. Thirteen patients had electrolyte determinations before and after bowel irrigation. The remaining patients underwent electrolyte determinations only after bowel preparation. The preparation was categorized by the attending surgeons as excellent, fair, or poor at the time of operation and recorded. An excellent preparation was free of particulate matter and fluid. A fair preparation had minimal particulate matter or a moderate amount of liquid stool, and a poor preparation had any solid feces. Follow-up for infectious complications was continued for 1 month postoperatively. A Student's t-test was used for statistical comparison. Values are expressed as mean and standard error of the mean.
RESULTS
Twelve males and nine females underwent Golytely bowel preparation for a variety of indications; colostomy closure (11), Hirschprung's disease (5), esophageal replacement (2), total colectomy and mucosal protectomy (2), and diverting colostomy (l). There were 11 patients < l year of age, seven children 1 to 5 years of age, and three children older than 5 years (average age 27.9 months, range 3 weeks to 14 years). The average weight was 11,8 _+2.9 kg. The mean duration of bowel preparation was 4 _+0.2 hours. Golytely delivery was accomplished by nasogastric tube in 14 patients, gastrostomy tube in three patients, and by mouth in four patients. Nasogastric tube position was confirmed by a physician in every patient. All patients completed their preparation without alteration of their calculated hourly requirements (25 mL/kg/h). Twenty patients tolerated the preparation well. One patient developed vomiting during bowel preparation. Metoclopramide, 0.1 mg/kg was given orally, and the preparation was continued successfully without further nausea or vomiting. Table 1 reflects the vital signs of the children before and after bowel preparation. Temperature, weight, heart rate, and respiratory rate decreased slightly. These changes were not statistically significant. Serum
MATERIALS AND METHODS Twenty-one patients required mechanical bowel preparation prior to surgery. All patients were allowed to eat ad lib until the day prior to surgery, when they were begun on a clear liquid diet. During the afternoon and evening, Golytely was given by mouth, nasogastric tube, or gastrostomy tube at a rate of 25 m L / k g / h for three to seven hours. To monitor tolerance to the preparation, infants were observed every 15 minutes during Golytely administration, while older children were checked hourly. Golytely was administered until the rectal effluent was clear and free of particulate matter. Enteral and parenteral antibiotics were used as an adjunct in these patients. Heart rate, respiratory rate, weight, and temperature were recorded
Journal of Pediatric Surgery, Vol 22, No 6 (June), 1987: pp 513-515
From the Department of Surgery, Section of Pediatric Surgery, University of Oklahoma College of Medicine, and the Oklahoma Children's Memorial Hospital, Oklahoma City, OK. Presented at the 35th Annual Meeting of the Surgical Section of the American Academy of Pediatrics, Washington, DC, November 1-2, 1986. Address reprint requests to David W. Tuggle, MD, Pediatric Surgery, PO Box 26307, Oklahoma City, OK 73126. 9 1987 by Grune & Stratton, Inc. 0022-3468/87/2206-0010503.00/0 513
514
TUGGLE ET AL
Table 1. Changes in Weight and Vital Signs After Golytely Preparation Temperature
Weight (kg)
(degrees C)
Heart Rate (beats/min)
RespiratoryRate (breaths/rain)
Before Golytely
11.8 • 2.9
3 6 . 7 _+ .07
126.7 _+ 5.2
3 2 _+ 2 . 8
After Golytely
11.8 • 2.8
3 6 . 6 • 0,1
123.9 +_ 6.1
3 0 + 2.1
Values expressed as mean • SEM.
electrolyte concentrations before and after Golytely preparation are shown in Table 2. No significant electrolyte changes were documented. The bowel preparation was judged intraoperatively by the attending surgeons and categorized as excellent, fair, or poor. Eighteen patients had excellent preparations, three had fair preparations, and none were judged to be poor. No postoperative wound or abdominal infection occurred in these patients. Our routine previously had been admission two days prior to surgery for bowel preparation. Sixteen patients in this series were admitted the day prior to surgery for preparation, thus reducing their hospital stay by one day and yielding an approximate savings of $350 per patient. DISCUSSION
Since first being introduced by Davis et al in 1980, 5 Golytely has rapidly become the fluid of choice for whole gut irrigation in many centers. ~6 Adult studies have shown that Golytely bowel cleansing is preferred over the standard three-day bowel preparation because it allows dietary freedom, short preparation time, and virtually eliminates enemasJ Goldman and associates 3 confirmed these findings and documented the safety of gut irrigation in patients with cardiac, renal, and pulmonary disease. Golytely has been shown effective in children as a preparation for colonoscopy.4 Our study demonstrates that Golytely can be safely used as a preoperative bowel preparation in children. Golytely contains 125 mmol/L of sodium, 40 mmol/ L of sulfate, 35 mmol/L of chloride, 20 mmol/L of bicarbonate, 10 mmol/L of potassium, and 17.6 mmol/L of polyethylene glycol. Polyethylene glycol 3350 is added as an osmotic agent to eliminate water absorption or secretion. It is not absorbed by normal intestinal mucosa and will not generate hydrogen when incubated with bacteria as mannitol does, thus decreasing the potential for bowel distention. The Table 2. Changes in Electrolytes After Golytely Bowel Preparation BeforeGolytely
After Golytely 139 + 1
Na(mg/L)
138_+ 1
K (mEq/L)
5.3 + 0.2
5.2 _+ 0 . 2
CI (mEq/L)
105 + 1.4
104 • 1.2
2 1 . 2 _+ 1.0
2 1 . 5 • 1.2
CO 2 (mEq/L)
Values expressed as mean _+ SEM.
electrolyte constituents of Golytely (particularly sulfate) were chosen because they cause no net electrolyte absorption or secretion when perfused through bowel segments. 5 The lack of significant changes in electrolyte concentration, weight, or vital signs after preparation support this data from adult studies. Even though more than half of our patients were under 1 year of age, our experience indicates that no significant change in weight, temperature, or electrolytes occurred in these smaller patients despite relatively large volumes of gut perfusate, further indicating the safety of this form of bowel preparation. Although no infectious complications occurred in any of our patients, we cannot reach any conclusions about the superiority of Golytely as a bowel preparation in reducing infections. Oral kanamycin or neomycin-erythromycin were each used in half of the patients while intravenous ampicillin and gentamicin were given perioperatively in all patients. Previous studies have demonstrated a significant decrease in colonic anaerobic bacteria after Golytely whole gut irrigation when compared with a traditional bowel preparation. 6 Aerobic growth remained similar, suggesting that a Golytely bowel preparation may be superior to the traditional method in eliminating colonic bacteria. When starting the clinical use of Golytely, we felt that no child would accept Golytely by mouth, because it has a slightly saltly bland taste. Therefore, most of our patients received their lavage by nasogastric or gastrostomy tube. However, a few children accepted the entire hourly amount by mouth and never required nasogastric intubation. If a nasogastric tube is required for Golytely delivery, its position should be confirmed by a physician and patients monitored closely during the preparation. The use of flavoring is discouraged because it may allow the production of luminal hydrogen, increasing the risk of distention, or change the concentration of electrolytes, allowing water or salt absorption or secretion. REFERENCES
1. ThomasG, BrozinskyS, EisenbergJ: Patient acceptanceand effectiveness of a balanced lavage solution (Golytely)versus the standard preparationfor colonoscopy.Gastroenterology82:435-437, 1982 2. ErnstoffJ J, Howard DA, Marshall JB, et al: A randomized blinded clinical trial of a rapid coloniclavage solution (Golytely) compared with standard preparation for colonoscopyand barium enema. Gastroenterology84:1512-1516, 1983
BOWEL PREPARATION IN CHILDREN
3. Goldman J, Reichelderfer M: Evaluation of a rapid colonoscopy preparation using a new gut lavage solution. Gastrointest Endosc 28:9-11, 1982 4. Tolia V, Fleming S, DuBois RS: Use of Golytely in children and adolescents. J Pediatr Gastroenterol Nutr 3:468-470, 1984 5. Davis G, Santa Ana C, Morawski S, et al: Development of a
515
lavage solution associated with minimal water and electrolyte absorption and secretion. Gastroeneterology 78:991-995, 1980 6. Fleites RA, Marshall JB, Eckhauser ML, et al: The efficacy of polyethylene glycol-electrolyte lavage solution versus traditional mechanical bowel preparation for elective colonic surgery: A randomized prospective blinded clinical trial. Surgery 98:708-716, 1985