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Percutaneous endoscopic gastrostomy: a randomized prospective comparison of early and delayed feeding
Percutaneous endoscopic gastrostomy: a randomized prospective comparison of early and delayed feeding Umesh Choudhry, MD, Christopher J. Barde, MD, Ronald Markert, PhD, Narasimh Gopalswamy, MD Dayton, Ohio
Background: It has been customary to initiate feeding through percutaneous endoscopic gastrostomy (PEG) tubes 24 hours or more after placement of these tubes. Recent changes in practice environment and emphasis on early discharge of hospitalized patients prompted us to evaluate early PEG feeding in a randomized prospective manner. Methods: Forty-one patients were included in the study. After an informed consent, the patients were randomly assigned to two groups. Group I (21 patients) received tube feedings 3 hours and Group il (20 patients) received feedings 24 hours after PEG placement. All patients received an iso-osmolar formula by continuous infusion at 30 ml/hour for the first 24 hours of feeding. The rates were then increased to 70 ml/hour. Residual volumes, tube length, peristomal leakage, and vital signs were checked, and a global assessment was done every 4 hours. Evaluation by a physician was done every 24 hours for 72 hours. If the residual volume was more than 60 ml (significant residual volume), the tube feedings were held for 2 hours. Patients exited the study at 72 hours from the time of procedure. All deaths were recorded to calculate 30-day mortality. Results: One patient (Group 2) died during the study period. Three patients (two in Group I and one in Group 2) had a significant residual volume. One patient (Group 1) had local skin infection requiring treatment. None of the patients had any signs of peritonitis or systemic infection. Conclusion: Early PEG tube feeding (3 hours after tube placement) is as safe as next day feeding in elderly patients. (Gastrointest Endosc 1996;44:164-7.) G a s t r o s t o m y feeding is f r e q u e n t l y employed in patients w h e n oral feeding is not possible for various reasons. Surgical g a s t r o s t o m y was conventionally used for this purpose. Over the last 15 years, percutaneous endoscopic g a s t r o s t o m y (PEG) tubes h a v e n e a r l y replaced surgical gastrostomy. Initially, most of the guidelines for the care a n d utilization of these tubes were e x t r a p o l a t e d from the experience of surgical gastrostomy. With P E G tubes being easily available and the t e c h n i q u e well established, a substantial original experience h a s been accumulated. Based on this experience, endoscopists believe t h a t the P E G Received July 18, 1995. For revision September 24, 1995. Accepted November 15, 1995. From the Wright State University School of Medicine and Division of Gastroenterology, VAMC, Dayton, Ohio. Presented in part at the annual meeting of the American College of Gastroenterology, August 1994, San Francisco, California. Reprint requests: Umesh Choudhry, MID, Center for Swallowing Disorders, University of South Florida Medical Center, MDC 72 12901, Bruce B. Downs Blvd., Tampa, FL 33612. 37/1/70646 164
GASTROINTESTINAL ENDOSCOPY
technique is not as invasive as the surgical technique. However, how soon a P E G tube can be utilized a f t e r insertion is s o m e w h a t uncertain. The p r e s e n t study examines this question in a r a n d o m i z e d prospective manner.
MATERIALS AND METHODS The study was conducted at the Veterans' Affairs Medical Center, Dayton, Ohio. A total of 44 patients, referred to the gastroenterology section for PEG tube placement from November 1993 to April 1995, were initially enrolled. Of these, 41 patients in whom PEG tubes were successfully placed were finally included in the study. The patients included were randomly assigned to two groups. In Group i the tube feeding was initiated at 3 hours after PEG placement. In Group 2 the feeding was initiated at 24 hours after PEG tube placement. Both groups were given nothing by mouth until their PEG tube feeding's could be initiated. All patients were then prospectively followed-up for 72 hours from the completion of the procedure. Tube feedings were provided by a continuous feeding pump and consisted of a full strength iso-osmolar formula. Both groups received feedings at a rate of 30 ml/hr for 24 hours from the time of initiation. The rate VOLUME 44, NO. 2, 1996
was then increased to 70 ml/hr. At the end of 72 hours, the tube feeds were allowed to be adjusted according to the nutritional requirements of the patients, as recommended by the nutrition support team.
Table 1. Demographics
Inclusion/exclusion criteria
Age (y)
All adult patients referred to the gastroenterology unit who had a clinical indication for a PEG tube were initially included in the study. The exclusion criteria were an inability to obtain an informed consent, a patient not expected to survive the duration of the study, any contraindications for endoscopy, inability to successfully transilluminate the abdominal wall, ascites, massive organomegaly, coagulopathy, and systemic infection.
Consent obtained from Patient Next of kin Location of follow-up Hospital Nursing home Hospital and nursing home Primary diagnosis HemiplegisdCVA/stroke Recurrent aspiration/ pneumonia Dysphagia Parkinson's disease Dementia Severe malnutrition Lung cancer ENT malignancy Muscular dystrophy Psychosis Prolonged need for nasogastric feeds Inability to feed self
PEG technique All patients were evaluated clinically by the gastroenterology consult team prior to PEG tube placement. Complete blood count, BUN, creatinine, electrolytes, prothrombin time, and partial thromboplastin time were checked in all patients. A chest x-ray was obtained when clinically indicated. The PEG tubes were placed in both groups using the Ponsky pull technique. 1 They were placed by two gastroenterology fellows under the direct supervision of an experienced gastroenterologist. Antibiotic prophylaxis in the form of cefazolin 1 gm was administered intravenously to all patients at the time of PEG placement. A note of the tube length outside the body was made by noting the centimeter mark on the tube that was in apposition to the skin. All patients received the newer variety removable PEG tubes with soft collapsible mushroom type inner bumper and external cross bar/disk. The incision site was cleaned with povidoneiodine solution (Betadine) and dressed with dry gauze after the procedure.
Observed parameters All patients were observed either in the hospital or at the on-campus nursing home facility. The parameters observed every 4 hours included an aspiration of the gastric contents and residual volume check, inspection of the tube site for leakage of tube feeds, bleeding, erythema, and a change in tube length. A global assessment, which included vital signs, abdominal distension, presence of bowel sounds, and abdominal tenderness, was also done by the nursing staff every 4 hours. A physician assessed each patient every 24 hours. This included a physical examination and a review of the nurses' notes from the previous 24 hours including a review of the residual volumes and available new laboratory data. Tube feeding was withheld for 2 hours if the residual volume at any given time was more than 60 ml (significant residual volume). Investigating physicians were called to assess the patient if the residual volume again remained greater than 60 ml at the end of 2 hours. A note was also made of the presence or absence of any prokinetic agents in the medication regimen of each patient.
Tube care Care of the gastrostomy tube included an examination of the gauze at the ostomy site for leakage every 4 hours, tube site leakage, daily cleaning with Betadine solution, and dry dressing. Hydrogen peroxide 1% solution was used only if VOLUME 44, NO. 2, 1996
Variable
Group 1 (n = 21)
Group2 (n = 20)
73.6 71.2 (SD = 8.0) (SD = 11.9)
p Value (sig< .05) .45 .45
6 15
3 17
14 6 1
15 5 0
10 3
7 2
0 2 1 1 0 3 1 0 0
1 1 2 1 3 0 0 1 1
0
1
1.00
.35
there was any purulent debris at the tube site. The PEG tubes were flushed with 50 ml tap water after every residual check.
Statistical analysis Student's t test was used to compare the two groups on continuous variables. Fisher's exact test was used for comparisons involving categorical variables. Inferences were made at the .05 level of significance.
RESULTS F o r t y - f o u r patients were referred to our u n i t d u r i n g the period of the study. Of these, 3 p a t i e n t s were excluded, all due to inability to t r a n s i l l u m i n a t e the abd o m i n a l wall because of scarring from previous abdominal surgeries. Forty-one patients, all m e n ( m e a n age, 72.3 years; range, 32 to 93 years) were finally included a n d r a n d o m i z e d in the study. The two groups were of comparable age, h a d similar indications for P E G placement, a n d were comparable according to the location of follow-up, as s h o w n in Table 1. The outcomes assessed included m a x i m u m residual volu m e s for each g r o u p for each day, adverse events, 30d a y mortality, n u m b e r of patients alive in each group at the t e r m i n a t i o n of the study, m e a n n u m b e r of days a p a t i e n t lived after P E G placement, a n d the n u m b e r of days b e t w e e n P E G p l a c e m e n t a n d t e r m i n a t i o n of the study. There was no statistical difference b e t w e e n the two groups with respect to the above outcomes (Table 2). There was one d e a t h d u r i n g the s t u d y period (Group 2). One p a t i e n t h a d tube-site infection (Group GASTROINTESTINAL ENDOSCOPY
165
Table 2. Outcomes Variable
Group 1 (n = 21)
Max residual volume(m]) Day 1 Day 2 Day 3 Local infection Fever Death Within 72 Hours Between day 4 and 30 Alive after 30 days Vomiting Significantresidual volume (>60 ml) Status at end of study Alive Dead
Group 2 p Value (n = 20) (sig< ,05)
17.4 8.5 (SD = 24.8) (SD = 13.0) 14.9 13.2 (SD = 19.1) (SD = 22.7) 8.1 16.5 (SD = 10.3) (SD = 21.6) 1 0 1 0 3 18 1 2
1 3 16 0 1
12 9
11 9
0
.16 .80 .13 1.00 1.00 .83
1.00 1.00 1.00
Mean duration: PEG to death 86.6 103.0 (days) (SD = 103.9)(SD = 109.3) Mean duration: PEG to end 328.0 303.2 of study (days) (SD = 144.1)(SD = 152.8)
.75 .60
1) and one patient (Group 1) had vomiting. Significant residual volume requiring holding the feeding for 2 hours was found in 3 patients (Group 1, 2 patients; Group 2, I patient). Leakage of the tube feeds around the PEG tube, significant bleeding from the gastrostomy site, PEG tube migration, peritonitis, clinically detected pneumoperitoneum, or abdominal distension or use of prokinetic agents was not noticed in any patient.
DISCUSSION Beginning with the description of the technique by Gauderer et al. 1 in 1980, PEG tubes have been placed successfully for 15 years. Many authors have published their experience over these years. 2"9 This has helped to establish the technique as safe, relatively non-invasive, and less expensive t h a n surgical gastrostomy. The tubes are placed under conscious sedation and local anesthesia. Hence, very sick patients can benefit from it, sometimes even at the bedside. In comparison to nasogastric tubes, PEG tubes also have the advantage of being socially and cosmetically more acceptable, better anchored, and relatively easy to manage (the last being a particularly important reason for these tubes being preferred by extended care facilities for a large number of patients requiring enteral nutrition). Over the past decade various common complications of this procedure have been well documented. These include benign pneumoperitoneum, wound infection, aspiration pneumonia, sepsis, tube 166 GASTROINTESTINAL ENDOSCOPY
migration, and consequent ileus or peritonitis and gastrocolic fistulae formation. 3.s Most of the earlier guidelines regarding the use and care of these tubes were a direct extrapolation of the experience gained from surgical gastrostomy tubes. Feeding through these tubes was then initiated anywhere from 24 to 72 hours after tube placement. 1° The patients were observed daily for signs of peritonitis and progression of bowel sounds. Even when feeding was started early, patients initially received only water for the first 24 hours, followed by one fourth to one half strength tube feedings. As endoscopists around the country gained more experience with these tubes, it became clear t h a t the bowel sounds returned fairly early or were present immediately after the procedure. 11 Flushing of PEG tubes with water on the day of tube placement has also been reported in the literature. Over the years, with increasing evidence of the advantages of enteral nutrition over parenteral nutrition, including a lesser chance of bacterial translocation in seriously ill patients and heightened cost consciousness in health care, the emphasis has been shifting towards evaluation of early feeding. 12 Early feeding is convenient for those receiving PEG tubes as outpatients and avoids the need for intravenous fluids. One of the earliest mentions of same day feeding is found in the study by Kirby et al. n In their 1986 prospective study of PEG tubes, they started the infusion of water 2 hours after PEG placement in a majority of their patients if bowel sounds were present. Since this was not the main objective of their study, they did not look at this aspect in a controlled manner. However, they did not report any untoward effects of this approach. Chumley et al.12 in 1992 presented a prospective nonrandomized study in which they compared same-day versus next-day utilization of PEG tubes. In this study 29 patients received feedings on the day of PEG placement, though this was not done in a uniform fashion. This group of patients was fed from 1.5 to 11 hours after the procedure. In another study, the same group reported a randomized prospective comparison of feeding at 3, 6, and 24 hours.l~ These data are conclusive t h a t there are no adverse effects associated with initiating the feedings soon after inserting the PEG tube. No differences were observed in the 3- and 6-hour groups in this study. Werlin et al. 14 recently published a study of 24 consecutive PEG tubes in children where they vented the PEG tubes for the first 2 hours, clamped it for the next 4 hours, and then started an electrolyte maintenance solution (Pedialyte) at 30 to 45 ml/hour. They successfully increased the feedings to the full complement of nutritional requirements within 24 hours. The reluctance of endoscopists to initiate PEG feedings early has stemmed from concerns regarding leakage of VOLUME 44, NO. 2, 1996
f o r m u l a into p e r i t o n e a l cavity t h r o u g h the f r e s h l y m a d e tract. N o l a n et al.15 a d d r e s s e d t h i s in a prospective s t u d y of 20 p a t i e n t s in a c o m m u n i t y hospital. T h e y d e m o n s t r a t e d t h a t t h e r e w a s no i n t r a p e r i t o n e a l or e x t e r n a l l e a k a g e of a r a d i o - o p a q u e dye a t 3 h o u r s or 24 h o u r s a f t e r P E G t u b e p l a c e m e n t . T h e p r e s e n t s t u d y involves elderly m a l e p a t i e n t s w i t h neurologic a n d o t h e r m u l t i p l e medical problems. T h a t t h e p o p u l a t i o n is r e p r e s e n t a t i v e of t h a t encount e r e d b y m o s t endoscopists i s a p p a r e n t f r o m the list of d i a g n o s e s a n d f r o m t h e fact t h a t only 9 of 41 p a t i e n t s w e r e able to provide a n i n f o r m e d consent t h e m s e l v e s (Table 1). A significant n u m b e r of t h e s e p a t i e n t s w e r e e i t h e r in a n u r s i n g h o m e or w e r e t r a n s f e r r e d f r o m t h e n u r s i n g h o m e s b e c a u s e of a c u t e illnesses. W e chose to initiate feeding a t 3 h o u r s in t h e e a r l y feeding g r o u p a f t e r carefully t a k i n g into account t h e t i m e t a k e n in p o s t p r o c e d u r e recovery, t r a n s p o r t to t h e w a r d or n u r s i n g home, a n d t i m e t a k e n to c a r r y out t h e orders once t h e p a t i e n t r e a c h e d t h e w a r d . O u r r e s u l t s clearly d e m o n s t r a t e t h a t t h e s e p a t i e n t s t o l e r a t e initiation of feeding at 3 h o u r s as well as t h e y do at 24 hours. All of o u r p a t i e n t s received a f u l l - s t r e n g t h f o r m u l a f r o m t h e beginning. W e believe it is not d e t r i m e n t a l to s t a r t w i t h f u l l - s t r e n g t h f o r m u l a if one is u s i n g a n iso-osmol a r formula. We chose to use a low r a t e initially for l a c k of b e t t e r knowledge. I t is quite likely t h a t w i t h m o r e e x p e r i e n c e e v e n this m a y c h a n g e in t h e future. T h e s t u d y design allowed p a t i e n t s to receive bolus t u b e feeding, t h o u g h this w a s not n e c e s s a r y in a n y patient. W e realize t h a t we s t u d i e d t h e s e p a t i e n t s for only 72 hours, b u t in o u r view this period is e n o u g h to detect a n y e a r l y f e e d i n g - r e l a t e d complications. To be able to objectively c o m p a r e our s t u d y g r o u p s w i t h o t h e r published d a t a , we calculated the 30-day m o r t a l i t y in o u r patients. T h e overall 30-day m o r t a l i t y r a t e w a s 17% a n d t h e r e w a s no significant difference b e t w e e n t h e two g r o u p s (p = 0.83). We did not receive a n y r e p o r t s f r o m the p r i m a r y care p h y s i c i a n s of peritonitis occurring w i t h i n 30 d a y s a f t e r P E G p l a c e m e n t in a n y p a t i e n t , n o r w a s this found on a c o m p u t e r r e v i e w w h e n c a l c u l a t i n g m o r t a l i t y . W e c o m p a r e d t h e two groups for t h e m e a n d u r a t i o n for which p a t i e n t s lived a f t e r P E G p l a c e m e n t a n d f o u n d t h e m s i m i l a r in t h i s respect. T h e r a t e of w o u n d infection in o u r s t u d y w a s v e r y low; this conforms w i t h o t h e r studies w h e r e p e r i p r o c e d u r e antibiotics a r e u s e d a n d good t u b e site care p e r f o r m e d , s We u s e d c o m m e r c i a l l y a v a i l a b l e P E G kits in all p a t i e n t s . The e x t e r n a l b u m p e r s in o u r s t u d y population w e r e not u n d u l y t i g h t e n e d a t t h e t i m e of t h e procedure. Hence, t h e r e w a s no n e e d to loosen t h e m over the n e x t d a y or two.
VOLUME 44, NO. 2, 1996
I n conclusion, it is safe, convenient, a n d m e d i c a l l y p r u d e n t to b e g i n t u b e feedings as e a r l y as 3 h o u r s in m e d i c a l l y ill elderly patients. W i t h t h o u s a n d s of P E G t u b e s b e i n g placed in t h e U n i t e d S t a t e s e v e r y year, this h a s a p o t e n t i a l for r e d u c i n g the d u r a t i o n of h y p e r a l i m e n t a t i o n a n d i n t r a v e n o u s m e d i c a t i o n s along w i t h o t h e r c o n s e q u e n t benefits.
ACKNOWLEDGMENTS The a u t h o r s especially acknowledge t h e contribution of R o b e r t Callon Jr., MD, in designing this study. We also e x p r e s s our sincere g r a t i t u d e to N a v K. G r a n dhi, MD, V i s h w a n a t h Shenoy, MD, N i a z U s m a n , MD, a n d the n u r s i n g s t a f f a t the D a y t o n VAMC for t h e i r c o n t r i b u t i o n to this study.
REFERENCES 1. Gauderer MWL, Ponsky JL, Izant RJ. Gastrostemy without laparotomy: a percutaneous endoscopic technique. J Pediatr Surg 1980;15:872-5. 2. Ponsky JL, Gauderer MWL. Percutaneous endoscopic gastrostomy: a nonoperative technique for feeding gastrostemy. Gastrointest Endosc 1981;27:9-11. 3. Mamel JJ. Percutaneous endoscopic gastrostemy. Am J Gastroenterol 1989;84:703-10. 4. Fay DE, Poplausky M, Gruber M, Lance P. Long term enteral feeding: a retrospective comparison of delivery via percutaneous endoscopic gastrostomy and nasoenteric tubes. Am J Gastroenterol 1991;86:1604-9. 5. Gauderer MWL. Percutaneous endoscopic gastrostemy: a 10year experience with 220 children. J Pediatr Surg 1991;26:28894. 6. Plumser AB, Gottfried EB, Clair MR. Pneumoperitoneum after percutaneous endoscopic gastrostomy. Am J Gastroenterol 1984;79:440-1. 7. Miller RE, Castlemain B, Lacqua FJ, Kotler DP. Percutaneous endoscopic gastrostemy. Results in 316 patients and review of literature. Surg Endosc 1989;3:186-90. 8. Larson DE, Burton DD, Schroeder KW, DiMagno EP. Percutaneous endoscopic gastrostomy. Indications, success, complications and mortality in 314 patients. Gastroenterology 1987;93: 48-52. 9. Kadakia SC, Sullivan HO, Starnes E. Percutaneous endoscopic gastrostomy or jejunostomy and the incidence of aspiration in 79 patients. Am J Surg 1992;164:114-8. 10. Stiegmann GV, GoffJS, Silas D, Pearlman N, Sun J, Norton L. Endoscopic versus operative gastrostemy: final results of a prospective randomized trial. Gastrointest Endosc 1990;36:1-5. 11. Kirby DF, Craig RM, Tsang T, Plotnick BH. Percutaneous endoscopic gastrostomies: a prospective evaluation and review of literature. JPEN J Parenter Enteral Nutr 1986;10:155-9. 12. Chumley DL, Bauer JO, Gossen GS, et al. Same day feeding, is it safe? [Abstract] Am J Gastroenterol 1992;87:1337. 13. Chumley DL, Batch WJ, Hoberman LJ, et al. Same day feeding, is it safe? Results of randomized prospective study [Abstract]. Am J Gastroenterol 1993;88:1589. 14. Werlin S, Glicklich M, Cohen R. Early feeding after percutaneous endoscopic gastrostemy is safe in children. Gastrointest Endosc 1994;40:692-3. 15. Nolan T, Callon R, Choudhry U, Reisinger P, Shaar CJ. Same day use of percutaneous endoscopic gastrostomy tubes: radiographic evidence of safety [Abstract]. Am J Gastroenterol 1994;89:1742.
GASTROINTESTINAL ENDOSCOPY
167
Background: It has been customary to initiate feeding through percutaneous endoscopic gastrostomy (PEG) tubes 24 hours or more after placement of these tubes. Recent changes in practice environment and emphasis on early discharge of hospitalized patients prompted us to evaluate early PEG feeding in a randomized prospective manner. Methods: Forty-one patients were included in the study. After an informed consent, the patients were randomly assigned to two groups. Group I (21 patients) received tube feedings 3 hours and Group il (20 patients) received feedings 24 hours after PEG placement. All patients received an iso-osmolar formula by continuous infusion at 30 ml/hour for the first 24 hours of feeding. The rates were then increased to 70 ml/hour. Residual volumes, tube length, peristomal leakage, and vital signs were checked, and a global assessment was done every 4 hours. Evaluation by a physician was done every 24 hours for 72 hours. If the residual volume was more than 60 ml (significant residual volume), the tube feedings were held for 2 hours. Patients exited the study at 72 hours from the time of procedure. All deaths were recorded to calculate 30-day mortality. Results: One patient (Group 2) died during the study period. Three patients (two in Group I and one in Group 2) had a significant residual volume. One patient (Group 1) had local skin infection requiring treatment. None of the patients had any signs of peritonitis or systemic infection. Conclusion: Early PEG tube feeding (3 hours after tube placement) is as safe as next day feeding in elderly patients. (Gastrointest Endosc 1996;44:164-7.) G a s t r o s t o m y feeding is f r e q u e n t l y employed in patients w h e n oral feeding is not possible for various reasons. Surgical g a s t r o s t o m y was conventionally used for this purpose. Over the last 15 years, percutaneous endoscopic g a s t r o s t o m y (PEG) tubes h a v e n e a r l y replaced surgical gastrostomy. Initially, most of the guidelines for the care a n d utilization of these tubes were e x t r a p o l a t e d from the experience of surgical gastrostomy. With P E G tubes being easily available and the t e c h n i q u e well established, a substantial original experience h a s been accumulated. Based on this experience, endoscopists believe t h a t the P E G Received July 18, 1995. For revision September 24, 1995. Accepted November 15, 1995. From the Wright State University School of Medicine and Division of Gastroenterology, VAMC, Dayton, Ohio. Presented in part at the annual meeting of the American College of Gastroenterology, August 1994, San Francisco, California. Reprint requests: Umesh Choudhry, MID, Center for Swallowing Disorders, University of South Florida Medical Center, MDC 72 12901, Bruce B. Downs Blvd., Tampa, FL 33612. 37/1/70646 164
GASTROINTESTINAL ENDOSCOPY
technique is not as invasive as the surgical technique. However, how soon a P E G tube can be utilized a f t e r insertion is s o m e w h a t uncertain. The p r e s e n t study examines this question in a r a n d o m i z e d prospective manner.
MATERIALS AND METHODS The study was conducted at the Veterans' Affairs Medical Center, Dayton, Ohio. A total of 44 patients, referred to the gastroenterology section for PEG tube placement from November 1993 to April 1995, were initially enrolled. Of these, 41 patients in whom PEG tubes were successfully placed were finally included in the study. The patients included were randomly assigned to two groups. In Group i the tube feeding was initiated at 3 hours after PEG placement. In Group 2 the feeding was initiated at 24 hours after PEG tube placement. Both groups were given nothing by mouth until their PEG tube feeding's could be initiated. All patients were then prospectively followed-up for 72 hours from the completion of the procedure. Tube feedings were provided by a continuous feeding pump and consisted of a full strength iso-osmolar formula. Both groups received feedings at a rate of 30 ml/hr for 24 hours from the time of initiation. The rate VOLUME 44, NO. 2, 1996
was then increased to 70 ml/hr. At the end of 72 hours, the tube feeds were allowed to be adjusted according to the nutritional requirements of the patients, as recommended by the nutrition support team.
Table 1. Demographics
Inclusion/exclusion criteria
Age (y)
All adult patients referred to the gastroenterology unit who had a clinical indication for a PEG tube were initially included in the study. The exclusion criteria were an inability to obtain an informed consent, a patient not expected to survive the duration of the study, any contraindications for endoscopy, inability to successfully transilluminate the abdominal wall, ascites, massive organomegaly, coagulopathy, and systemic infection.
Consent obtained from Patient Next of kin Location of follow-up Hospital Nursing home Hospital and nursing home Primary diagnosis HemiplegisdCVA/stroke Recurrent aspiration/ pneumonia Dysphagia Parkinson's disease Dementia Severe malnutrition Lung cancer ENT malignancy Muscular dystrophy Psychosis Prolonged need for nasogastric feeds Inability to feed self
PEG technique All patients were evaluated clinically by the gastroenterology consult team prior to PEG tube placement. Complete blood count, BUN, creatinine, electrolytes, prothrombin time, and partial thromboplastin time were checked in all patients. A chest x-ray was obtained when clinically indicated. The PEG tubes were placed in both groups using the Ponsky pull technique. 1 They were placed by two gastroenterology fellows under the direct supervision of an experienced gastroenterologist. Antibiotic prophylaxis in the form of cefazolin 1 gm was administered intravenously to all patients at the time of PEG placement. A note of the tube length outside the body was made by noting the centimeter mark on the tube that was in apposition to the skin. All patients received the newer variety removable PEG tubes with soft collapsible mushroom type inner bumper and external cross bar/disk. The incision site was cleaned with povidoneiodine solution (Betadine) and dressed with dry gauze after the procedure.
Observed parameters All patients were observed either in the hospital or at the on-campus nursing home facility. The parameters observed every 4 hours included an aspiration of the gastric contents and residual volume check, inspection of the tube site for leakage of tube feeds, bleeding, erythema, and a change in tube length. A global assessment, which included vital signs, abdominal distension, presence of bowel sounds, and abdominal tenderness, was also done by the nursing staff every 4 hours. A physician assessed each patient every 24 hours. This included a physical examination and a review of the nurses' notes from the previous 24 hours including a review of the residual volumes and available new laboratory data. Tube feeding was withheld for 2 hours if the residual volume at any given time was more than 60 ml (significant residual volume). Investigating physicians were called to assess the patient if the residual volume again remained greater than 60 ml at the end of 2 hours. A note was also made of the presence or absence of any prokinetic agents in the medication regimen of each patient.
Tube care Care of the gastrostomy tube included an examination of the gauze at the ostomy site for leakage every 4 hours, tube site leakage, daily cleaning with Betadine solution, and dry dressing. Hydrogen peroxide 1% solution was used only if VOLUME 44, NO. 2, 1996
Variable
Group 1 (n = 21)
Group2 (n = 20)
73.6 71.2 (SD = 8.0) (SD = 11.9)
p Value (sig< .05) .45 .45
6 15
3 17
14 6 1
15 5 0
10 3
7 2
0 2 1 1 0 3 1 0 0
1 1 2 1 3 0 0 1 1
0
1
1.00
.35
there was any purulent debris at the tube site. The PEG tubes were flushed with 50 ml tap water after every residual check.
Statistical analysis Student's t test was used to compare the two groups on continuous variables. Fisher's exact test was used for comparisons involving categorical variables. Inferences were made at the .05 level of significance.
RESULTS F o r t y - f o u r patients were referred to our u n i t d u r i n g the period of the study. Of these, 3 p a t i e n t s were excluded, all due to inability to t r a n s i l l u m i n a t e the abd o m i n a l wall because of scarring from previous abdominal surgeries. Forty-one patients, all m e n ( m e a n age, 72.3 years; range, 32 to 93 years) were finally included a n d r a n d o m i z e d in the study. The two groups were of comparable age, h a d similar indications for P E G placement, a n d were comparable according to the location of follow-up, as s h o w n in Table 1. The outcomes assessed included m a x i m u m residual volu m e s for each g r o u p for each day, adverse events, 30d a y mortality, n u m b e r of patients alive in each group at the t e r m i n a t i o n of the study, m e a n n u m b e r of days a p a t i e n t lived after P E G placement, a n d the n u m b e r of days b e t w e e n P E G p l a c e m e n t a n d t e r m i n a t i o n of the study. There was no statistical difference b e t w e e n the two groups with respect to the above outcomes (Table 2). There was one d e a t h d u r i n g the s t u d y period (Group 2). One p a t i e n t h a d tube-site infection (Group GASTROINTESTINAL ENDOSCOPY
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Table 2. Outcomes Variable
Group 1 (n = 21)
Max residual volume(m]) Day 1 Day 2 Day 3 Local infection Fever Death Within 72 Hours Between day 4 and 30 Alive after 30 days Vomiting Significantresidual volume (>60 ml) Status at end of study Alive Dead
Group 2 p Value (n = 20) (sig< ,05)
17.4 8.5 (SD = 24.8) (SD = 13.0) 14.9 13.2 (SD = 19.1) (SD = 22.7) 8.1 16.5 (SD = 10.3) (SD = 21.6) 1 0 1 0 3 18 1 2
1 3 16 0 1
12 9
11 9
0
.16 .80 .13 1.00 1.00 .83
1.00 1.00 1.00
Mean duration: PEG to death 86.6 103.0 (days) (SD = 103.9)(SD = 109.3) Mean duration: PEG to end 328.0 303.2 of study (days) (SD = 144.1)(SD = 152.8)
.75 .60
1) and one patient (Group 1) had vomiting. Significant residual volume requiring holding the feeding for 2 hours was found in 3 patients (Group 1, 2 patients; Group 2, I patient). Leakage of the tube feeds around the PEG tube, significant bleeding from the gastrostomy site, PEG tube migration, peritonitis, clinically detected pneumoperitoneum, or abdominal distension or use of prokinetic agents was not noticed in any patient.
DISCUSSION Beginning with the description of the technique by Gauderer et al. 1 in 1980, PEG tubes have been placed successfully for 15 years. Many authors have published their experience over these years. 2"9 This has helped to establish the technique as safe, relatively non-invasive, and less expensive t h a n surgical gastrostomy. The tubes are placed under conscious sedation and local anesthesia. Hence, very sick patients can benefit from it, sometimes even at the bedside. In comparison to nasogastric tubes, PEG tubes also have the advantage of being socially and cosmetically more acceptable, better anchored, and relatively easy to manage (the last being a particularly important reason for these tubes being preferred by extended care facilities for a large number of patients requiring enteral nutrition). Over the past decade various common complications of this procedure have been well documented. These include benign pneumoperitoneum, wound infection, aspiration pneumonia, sepsis, tube 166 GASTROINTESTINAL ENDOSCOPY
migration, and consequent ileus or peritonitis and gastrocolic fistulae formation. 3.s Most of the earlier guidelines regarding the use and care of these tubes were a direct extrapolation of the experience gained from surgical gastrostomy tubes. Feeding through these tubes was then initiated anywhere from 24 to 72 hours after tube placement. 1° The patients were observed daily for signs of peritonitis and progression of bowel sounds. Even when feeding was started early, patients initially received only water for the first 24 hours, followed by one fourth to one half strength tube feedings. As endoscopists around the country gained more experience with these tubes, it became clear t h a t the bowel sounds returned fairly early or were present immediately after the procedure. 11 Flushing of PEG tubes with water on the day of tube placement has also been reported in the literature. Over the years, with increasing evidence of the advantages of enteral nutrition over parenteral nutrition, including a lesser chance of bacterial translocation in seriously ill patients and heightened cost consciousness in health care, the emphasis has been shifting towards evaluation of early feeding. 12 Early feeding is convenient for those receiving PEG tubes as outpatients and avoids the need for intravenous fluids. One of the earliest mentions of same day feeding is found in the study by Kirby et al. n In their 1986 prospective study of PEG tubes, they started the infusion of water 2 hours after PEG placement in a majority of their patients if bowel sounds were present. Since this was not the main objective of their study, they did not look at this aspect in a controlled manner. However, they did not report any untoward effects of this approach. Chumley et al.12 in 1992 presented a prospective nonrandomized study in which they compared same-day versus next-day utilization of PEG tubes. In this study 29 patients received feedings on the day of PEG placement, though this was not done in a uniform fashion. This group of patients was fed from 1.5 to 11 hours after the procedure. In another study, the same group reported a randomized prospective comparison of feeding at 3, 6, and 24 hours.l~ These data are conclusive t h a t there are no adverse effects associated with initiating the feedings soon after inserting the PEG tube. No differences were observed in the 3- and 6-hour groups in this study. Werlin et al. 14 recently published a study of 24 consecutive PEG tubes in children where they vented the PEG tubes for the first 2 hours, clamped it for the next 4 hours, and then started an electrolyte maintenance solution (Pedialyte) at 30 to 45 ml/hour. They successfully increased the feedings to the full complement of nutritional requirements within 24 hours. The reluctance of endoscopists to initiate PEG feedings early has stemmed from concerns regarding leakage of VOLUME 44, NO. 2, 1996
f o r m u l a into p e r i t o n e a l cavity t h r o u g h the f r e s h l y m a d e tract. N o l a n et al.15 a d d r e s s e d t h i s in a prospective s t u d y of 20 p a t i e n t s in a c o m m u n i t y hospital. T h e y d e m o n s t r a t e d t h a t t h e r e w a s no i n t r a p e r i t o n e a l or e x t e r n a l l e a k a g e of a r a d i o - o p a q u e dye a t 3 h o u r s or 24 h o u r s a f t e r P E G t u b e p l a c e m e n t . T h e p r e s e n t s t u d y involves elderly m a l e p a t i e n t s w i t h neurologic a n d o t h e r m u l t i p l e medical problems. T h a t t h e p o p u l a t i o n is r e p r e s e n t a t i v e of t h a t encount e r e d b y m o s t endoscopists i s a p p a r e n t f r o m the list of d i a g n o s e s a n d f r o m t h e fact t h a t only 9 of 41 p a t i e n t s w e r e able to provide a n i n f o r m e d consent t h e m s e l v e s (Table 1). A significant n u m b e r of t h e s e p a t i e n t s w e r e e i t h e r in a n u r s i n g h o m e or w e r e t r a n s f e r r e d f r o m t h e n u r s i n g h o m e s b e c a u s e of a c u t e illnesses. W e chose to initiate feeding a t 3 h o u r s in t h e e a r l y feeding g r o u p a f t e r carefully t a k i n g into account t h e t i m e t a k e n in p o s t p r o c e d u r e recovery, t r a n s p o r t to t h e w a r d or n u r s i n g home, a n d t i m e t a k e n to c a r r y out t h e orders once t h e p a t i e n t r e a c h e d t h e w a r d . O u r r e s u l t s clearly d e m o n s t r a t e t h a t t h e s e p a t i e n t s t o l e r a t e initiation of feeding at 3 h o u r s as well as t h e y do at 24 hours. All of o u r p a t i e n t s received a f u l l - s t r e n g t h f o r m u l a f r o m t h e beginning. W e believe it is not d e t r i m e n t a l to s t a r t w i t h f u l l - s t r e n g t h f o r m u l a if one is u s i n g a n iso-osmol a r formula. We chose to use a low r a t e initially for l a c k of b e t t e r knowledge. I t is quite likely t h a t w i t h m o r e e x p e r i e n c e e v e n this m a y c h a n g e in t h e future. T h e s t u d y design allowed p a t i e n t s to receive bolus t u b e feeding, t h o u g h this w a s not n e c e s s a r y in a n y patient. W e realize t h a t we s t u d i e d t h e s e p a t i e n t s for only 72 hours, b u t in o u r view this period is e n o u g h to detect a n y e a r l y f e e d i n g - r e l a t e d complications. To be able to objectively c o m p a r e our s t u d y g r o u p s w i t h o t h e r published d a t a , we calculated the 30-day m o r t a l i t y in o u r patients. T h e overall 30-day m o r t a l i t y r a t e w a s 17% a n d t h e r e w a s no significant difference b e t w e e n t h e two g r o u p s (p = 0.83). We did not receive a n y r e p o r t s f r o m the p r i m a r y care p h y s i c i a n s of peritonitis occurring w i t h i n 30 d a y s a f t e r P E G p l a c e m e n t in a n y p a t i e n t , n o r w a s this found on a c o m p u t e r r e v i e w w h e n c a l c u l a t i n g m o r t a l i t y . W e c o m p a r e d t h e two groups for t h e m e a n d u r a t i o n for which p a t i e n t s lived a f t e r P E G p l a c e m e n t a n d f o u n d t h e m s i m i l a r in t h i s respect. T h e r a t e of w o u n d infection in o u r s t u d y w a s v e r y low; this conforms w i t h o t h e r studies w h e r e p e r i p r o c e d u r e antibiotics a r e u s e d a n d good t u b e site care p e r f o r m e d , s We u s e d c o m m e r c i a l l y a v a i l a b l e P E G kits in all p a t i e n t s . The e x t e r n a l b u m p e r s in o u r s t u d y population w e r e not u n d u l y t i g h t e n e d a t t h e t i m e of t h e procedure. Hence, t h e r e w a s no n e e d to loosen t h e m over the n e x t d a y or two.
VOLUME 44, NO. 2, 1996
I n conclusion, it is safe, convenient, a n d m e d i c a l l y p r u d e n t to b e g i n t u b e feedings as e a r l y as 3 h o u r s in m e d i c a l l y ill elderly patients. W i t h t h o u s a n d s of P E G t u b e s b e i n g placed in t h e U n i t e d S t a t e s e v e r y year, this h a s a p o t e n t i a l for r e d u c i n g the d u r a t i o n of h y p e r a l i m e n t a t i o n a n d i n t r a v e n o u s m e d i c a t i o n s along w i t h o t h e r c o n s e q u e n t benefits.
ACKNOWLEDGMENTS The a u t h o r s especially acknowledge t h e contribution of R o b e r t Callon Jr., MD, in designing this study. We also e x p r e s s our sincere g r a t i t u d e to N a v K. G r a n dhi, MD, V i s h w a n a t h Shenoy, MD, N i a z U s m a n , MD, a n d the n u r s i n g s t a f f a t the D a y t o n VAMC for t h e i r c o n t r i b u t i o n to this study.
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