Pilot study on gastric electrical stimulation on surgery-associated gastroparesis: long-term outcome.Objectives: Patients with postgastric surgery gastroparesis are often unresponsive to conventional medical therapy. Gastric electrical stimulation (GES GES GTN (Global Transportation Network) Exercise System GES General Estimates System (NHTSA) GES Ghana Education Service GES Government Economic Service (UK) ) with the use of high-frequency and low-energy neural stimulation is an approved technique for patients with idiopathic and diabetic gastroparesis. Methods: We hypothesized that GES would improve symptoms, health resource utilization, and gastric emptying in six patients with postsurgical gastroparesis from a variety of surgical procedures. Patients were evaluated by means of the following criteria: symptoms, health-related quality of life, and gastric emptying tests at baseline over time. Results: All patients noted improvements after device implantation for up to 46 months: the frequency score for weekly vomiting went from a baseline of 3.2 down to 0.4 immediately after treatment before settling at 1.4 by the long-term follow up. Total gastrointestinal symptom score went from 36.5 at baseline down to 12.3 before settling at 20.5 at long-term follow up. Improvements were also seen in health-related quality of life and solid and liquid gastric emptying. Conclusions: We conclude that GES is associated with clinical improvements in this group of patients with either postsurgical or surgery-associated gastroparesis. This pilot study with long-term outcomes offers evidence for a new therapy for otherwise refractory patients with gastroparesis associated with previous surgery. Key Words: Electrical stimulation, gastroparesis, postgastrectomy syndromes ********** Gastroparesis is a potential complication of diseases such as diabetes mellitus diabetes mellitus Disorder of insufficient production of or reduced sensitivity to insulin. Insulin, synthesized in the islets of Langerhans (see Langerhans, islets of), is necessary to metabolize glucose. In diabetes, blood sugar levels increase (hyperglycemia). , although many patients have the disease from an unidentified source. Gastroparesis may also occur after upper gastrointestinal (GI) surgical procedures, regardless of dyspeptic dys·pep·tic adj. 1. Relating to or having dyspepsia. 2. Of or displaying a morose disposition. n. A person who is affected by dyspepsia. symptoms. (1-4) For patients with diabetic or idiopathic gastroparesis, gastric electrical stimulation (GES) has shown promise; (5) however, the procedure has not been studied in a diverse group of patients whose gastroparesis is associated with surgery. GES differs from gastric pacing in the location of the applied stimulus: in the latter, the stimulus is applied to the muscle itself, whereas in the former, the neural stimulation is applied to the enteric nervous system The enteric nervous system (ENS) is the part of the nervous system that directly controls the gastrointestinal system. It is capable of autonomous functions such as the coordination of reflexes, although it receives considerable innervation from the autonomic nervous system . Although gastric pacing has had mixed results, (6) GES is now an accepted therapy for drug-refractory gastroparesis of idiopathic or diabetic origin. Because GES has shown promise for other types of gastroparesis, we hypothesized that patients with postsurgical gastroparesis might also benefit from this therapy. We now report on a pilot study of six patients with postsurgical gastroparesis who are 12 months status post-GES. These were the first six patients seen with postsurgical/surgery-associated gastroparesis among 14 patients implanted in the gastric electrical mechanical stimulation (GEMS) protocol. (5) During this same period, another 33 patients were implanted with GES as part of the World Anti Vomiting Electrical Stimulation Study (WAVESS) (7) protocol, but previous gastric surgery was an exclusion for that protocol. The sixth patient was implanted after GES received approval as a humanitarian use device in 2000. Materials and Methods Six eligible patients (two men and four women; mean age, 39 years), all involved in humanitarian and investigational trials, were reviewed for this study. All patients had documented gastroparesis after previous gastric surgery, including gastrojejunostomy (n = 2), partial gastrectomy gastrectomy Surgical removal of all or part of the stomach to treat peptic ulcers. It eliminates the cells that secrete acid and halts the production of gastrin, the hormone that stimulates them. Once a common operation, it is now a last resort. (n = 1), Nissen fundoplication Nissen fundoplication Neonatology A laparoscopic procedure for treating reflux esophagitis and GERD. See Gastroesophageal reflux disease, Nissen fundoplication. (n = 2), and vagotomy/pyloroplasty (n = 1), undertaken for a variety of common GI disorders including gastroesophageal reflux disease gastroesophageal reflux disease (GERD) Disorder characterized by frequent passage of gastric contents from the stomach back into the esophagus. Symptoms of GERD may include heartburn, coughing, frequent clearing of the throat, and difficulty in swallowing. , peptic ulcer disease Peptic ulcer disease (PUD) A stomach disorder marked by corrosion of the stomach lining due to the acid in the digestive juices. Mentioned in: Indigestion peptic ulcer disease See Duodenal ulcer, Gastric ulcer, GERD. , and gastric outlet obstruction gastric outlet obstruction Gastroenterology A manifestation of gastric dysmotility; the rate of gastric emptying is controlled by duodenal receptors for fat or acid Etiology Ulcers, benign or malignant tumors, inflammation–cholecystitis, acute pancreatitis or . Of the six patients, all had some dyspeptic symptoms preceding their gastric surgery (with a mean age of 6.7 years of symptoms before gastric surgery and a mean of 45.6 months since the implantation GES device), but all patients had worsening of symptoms after surgery (see Table 1). All patients were drug-refractory and had undergone extensive evaluations before GES device placement. The GES device (Itrel, Medtronic, Minneapolis, MN) was implanted by use of the following procedure. Initially, a temporary GES device was placed with modified fetal scalp electrodes placed through a percutaneous endoscopic gastrostomy percutaneous endoscopic gastrostomy See PEG. (PEG) tube ostomy ostomy Surgical opening in the body, or the operation creating it, usually to allow discharge of wastes through the abdominal wall. It may be temporary, to relieve strain on damaged organs, or permanent, to replace normal channels congenitally missing or surgically removed with either endoscopic en·do·scope n. An instrument for examining visually the interior of a bodily canal or a hollow organ such as the colon, bladder, or stomach. en guidance or via minilaparotomy, with the leads connected to an external stimulator to see if both GI symptoms and gastric emptying test (GET) results improved. After a successful trial of temporary stimulation, the patients were converted to a permanent stimulator with electrodes surgically placed on the serosal surface of the distal stomach remnant, with the stimulator in a subcutaneous pocket. Patients were evaluated for subjective signs of illness according to a self-reported vomiting frequency score (VFS VFS Virtual File System VFS Vancouver Film School VFS Virtual Filesystem Switch VFS Veritas File System VFS Vines File System VFS Virtual Fighting Squad (gaming) VFS Vehicle Fighting System VFS Virtual Filesystem Switching ) (range, 0 to 4) (7) and a GI total symptom score (TSS See ITU. ), measuring for nausea, vomiting, bloating bloating Vox populi A lay term for post-prandial abdominal fullness or swelling , abdominal pain, and anorexia (range, 0 to 50). (8) Health-related quality of life (HRQOL HRQOL Health-Related Quality of Life ), measured by an investigator-derived independent outcome score (IDIOMS score), (8) and gastric emptying time emptying time the time taken for stomach contents to be passed into the duodenum; influenced by gastric motility and activity of the pyloric sphincter. for liquids (after 1 and 2 hours) (9) and for solids (after 2 and 4 hours) (9) was used to evaluate objective manifestations of their illness. Data points were collected at baseline after temporary stimulation and after 3-, 6-, and 12-month intervals after the procedure. Results were compared by paired t tests from baseline and were reported as mean plus or minus standard error. Results were reported as statistically significant for P [less than or equal to] 0.01, using Bonferroni correction for multiple comparisons; P values between 0.01 and 0.10 were considered borderline. [FIGURE 1 OMITTED] Results A summary of the results and percent improvement from baseline is provided in Table 2. Of the six original patients, five had simulators at the end of 2002; one device was removed because of a fistula fistula (fĭs`ch  lə), abnormal, usually ulcerous channellike formation between two internal organs or between an internal organ and the skin. (at the
site of a prior, unrelated abdominal surgery) after 11 months; data on
this patient were collected for the first 11 months.
Symptoms VFS improved from 3.2 at baseline to 0.4 after temporary stimulation, to 0.9 after 3 months, 1.3 after 6 months, and 0.3 after 12 months; at the latest follow up (mean, 45.6 months), VFS was maintained at 1.4 (P < 0.10, Fig. 1). GI TSS improved from 36.5 at baseline to 12.3 after temporary stimulation, 10.4 after 3 months, 12.5 after 6 months, and 8.5 after 12 months; at the latest follow up, TSS was 20.5 (P < 0.10, Fig. 2). Health-related Quality of Life Quality of life improved after implantation of the GES device, as reported by a decrease in the IDIOMs score, from a baseline of 13.2 to 7.7 after 3 months, 7.2 after 6 months, and 6 after 12 months; at last follow up, the IDIOMs score was 7.3. P values compared with baseline were all 0.05 or less and of borderline significance (Fig. 3). [FIGURE 2 OMITTED] Gastric emptying time Liquid GET, which measures the percentage remaining in the stomach after 1 hour, showed a trend toward improvement from 73.6% at baseline to 52.6% after temporary stimulation to 63.3% after 3 months, 42.3% after 6 months, and 40.7% after 12 months, (P values were all > 0.05). Liquid GET after 2 hours improved as well from 60.2% at baseline to 27% after temporary stimulation to 46.3% after 3 months, 30.6% after 6 months, and 24.6% after 12 months; P values were all greater than 0.01 (Fig. 4). In addition to the patient whose device was removed before month 12, one other patient did not have a baseline liquid GET. Solid GET, measuring a percentage of what remains at 2 hours, improved from 76.8% at baseline to 52% after temporary stimulation, to 67% after 3 months, 54.7% after 6 months, and 50% after 12 months; at the latest follow up, 2-hour solid GET was 63% (P > 0.05). Solid GET at 4 hours improved from 71.4% at baseline to 41.6% at temporary, to 41% after 3 months, 36.7% after 6 months, and 15% after 12 months. At the latest follow up, a 4-hour solid GET was 30% (P < 0.05). See Figure 5. [FIGURE 3 OMITTED] [FIGURE 4 OMITTED] Discussion Patients with postsurgical gastric motor disorders are frequently refractory to medical therapy, and a total or near-total gastrectomy (a "completion" gastrectomy) is frequently the only viable option. (10-14) Completion gastrectomy is shown to decrease long-term symptoms in 80% of patients, whereas the other 20% remain symptomatic and require further treatment. (1) Although total gastrectomy Total gastrectomy Surgical removal (excision) of the entire stomach. Mentioned in: Stomach Cancer does improve symptoms in the majority of cases, it is associated with significant perioperative perioperative /peri·op·er·a·tive/ (-op´er-ah-tiv) pertaining to the period extending from the time of hospitalization for surgery to the time of discharge. per·i·op·er·a·tive adj. morbidity and mortality Morbidity and Mortality can refer to:
ste·a·tor·rhe·a or ste·a·tor·rhoe·a n. , dumping syndrome dump·ing syndrome n. A condition occurring after eating in patients with shunts of the upper alimentary canal and including flushing, sweating, dizziness, weakness, and vasomotor collapse. Also called postgastrectomy syndrome. , malnutrition, osteoporosis, and osteomalacia osteomalacia /os·teo·ma·la·cia/ (os?te-o-mah-la´shah) inadequate or delayed mineralization of osteoid in mature cortical and spongy bone; it is the adult equivalent of rickets and accompanies that disorder in children. . (14-17) Our study is a pilot trial of the application of a novel technique for the treatment of postsurgical gastroparesis, a technique that does not disrupt gastric anatomy any further. GES involves the use of low-energy, higher-than-baseline frequency neural stimulation and thus differs from gastric pacing, in which the stimulus is directly applied to the muscle. GES has been applied to the treatment of diabetic or idiopathic gastroparesis, resulting in a significant reduction in weekly vomiting frequency and improvement in TSS. (5) Our patient population included five patients who were part of the GEMS trial, which followed patients' symptoms for 12 months. As in the GEMS study, our patients showed improvement in vomiting and overall GI symptoms. In addition, roughly 80% of our patients showed symptom improvement with GES comparable to that seen with gastrectomy. We also include data on HRQOL, which was not previously reported in the GEMS trial. The improvements in HRQOL are significant, specifically when compared with HRQOL associated with gastrectomy. Ishihara et al (17) reported that HRQOL was thought to be poor in 41% of patients receiving total gastrectomy for gastric carcinoma. HRQOL as measured by an IDIOMS score reflects diminished severity of illness, intensity of service, and comorbid conditions. As such, GES has a positive effect on health resource measures. In addition to improvement in symptoms and health resources, we noted improvement in gastric emptying of both solids and liquids. Although the mechanism for the improvement in GET is currently unknown, evidence exists that the effect of GET is related to improvement of enteric enteric /en·ter·ic/ (en-ter´ik) within or pertaining to the small intestine. en·ter·ic adj. 1. Of, relating to, or within the intestine. 2. neural and/or autonomic nervous system autonomic nervous system: see nervous system. autonomic nervous system Part of the nervous system that is not under conscious control and that regulates the internal organs. It includes the sympathetic, parasympathetic, and enteric nervous systems. function. (18) A recent study of GES showed a positive effect on nutrition, although nutritional indices were not recorded in this study. (19) Although this trial has several limitations, notably a small sample size, the nature of the improvements and the long-term follow up suggest a possible role for GES in patients who have gastroparesis after surgery. To date, these patients are largely refractory to medical therapy and often undergo further surgical therapy. Surgical therapy for gastric esophageal reflux esophageal reflux n. See gastroesophageal reflux. disease is now commonplace, and gastric surgery for peptic ulcer disease remains a mainstay of therapy for patients at increased risk of rebleeding. With the complication rate of vagotomy Vagotomy Definition Vagotomy is the surgical cutting of the vagus nerve to reduce acid secretion in the stomach. Purpose The vagus nerve splits into branches that go to different parts of the stomach. and gastric drainage procedures at nearly 30%, (20) GES may provide a less invasive alternative to total gastrectomy in the subset of patients with surgery-associated gastroparesis. [FIGURE 5 OMITTED] In our series of patients, the surgeries performed resulted in either removal or disruption of the gastric anatomy and its innervation innervation /in·ner·va·tion/ (in?er-va´shun) 1. the distribution or supply of nerves to a part. 2. the supply of nervous energy or of nerve stimulation sent to a part. , and may be a factor in the patients' development of gastroparesis. (4) The pathophysiology pathophysiology /patho·phys·i·ol·o·gy/ (-fiz?e-ol´ah-je) the physiology of disordered function. path·o·phys·i·ol·o·gy n. 1. of this entity has not been fully elucidated, however, and further investigation is warranted. Moreover, the term postsurgical gastroparesis implies that gastroparesis occurs in the postoperative period and is directly caused by the surgery. Given the uncertainty of the cause, we believe that it is more appropriate to label these patients as having surgery-associated gastroparesis, which does not imply causality. Conclusion We conclude that in this group of six patients with postsurgical/surgery-associated gastroparesis, GES has shown improvement in total GI symptoms, including vomiting frequency, HRQOL, and gastric emptying over long-term follow up of nearly 4 years. On the basis of the current study, GES deserves further investigation in controlled trials for patients with surgery-associated gastric motor disorders. Acknowledgments The authors thank Warren Starkebaum at Medtronic, Inc. for reviewing the manuscript and Christy Newman and Cecelia Delbridge for assistance in preparation of the manuscript. References 1. Eckhauser FE, Conrad M, Knol JA, et al. Safety and long-term durability of completion gastrectomy in 81 patients with postsurgical gastroparesis syndrome. AmSurg 1998;64:711-717. 2. Kozarek RA, Low DE, Raltz SL. Complications associated with laparoscopic Laparoscopic A minimally-invasive surgical or diagnostic procedure that uses a flexible endoscope (laparoscope) to view and operate on structures in the abdomen. Mentioned in: Obstetrical Emergencies anti-reflux surgery: one multispecialty clinic's experience. Gastrointest Endosc 1997;46:527-531. 3. Eckhauser FE, Knol JA, Raper SA, et al. Completion gastrectomy for postsurgical gastroparesis syndrome: preliminary results with 15 patients. Ann Surg 1988;208:345-353. 4. Tobi M, Holtz T, Carethers J, et al. Delayed gastric emptying after laparoscopic anterior highly selective and posterior truncal truncal /trun·cal/ (trung´k'l) pertaining to the trunk. trun·cal adj. 1. Of or relating to the trunk of the body. 2. Of or relating to an arterial or nerve trunk. vagotomy. Am J Gastroenterol 1995;90:810-811. 5. Abell TL, Van Cutsem E, Abrahamsson H, et al. Gastric electrical stimulation in intractable symptomatic gastroparesis. Digestion 2002;66:204-212. 6. Bortolotti M. The "electrical way" to cure gastroparesis. Am J Gastroenterol 2002;97:1874-1883. 7. Abell T, McCallum R, Hocking Hocking may refer to:
8. Cutts T, Luo J, Starkebaum W, et al. Is gastric electrical stimulation superior to standard pharmacologic therapy in improving GI symptoms, healthcare resources, and long-term health care costs? Neurogastroenterol Motil 2005;17:35-43. 9. Abell TL, Camilleri M, Hench VS, et al. Gastric electromechanical The use of electricity to run moving parts. Disk drives, printers and motors are examples. Electromechanical systems must be designed for the eventual deterioration of moving components that wear over time. The first TVs were electromechanical systems (see video/TV history). function and gastric emptying in diabetic gastroparesis. Eur J Gastroenterol Hepatol 1991;3:163-167. 10. Vogel SB, Drane WE, Woodward ER. Clinical and radionuclide radionuclide /ra·dio·nu·clide/ (-noo´klid) a nuclide that disintegrates with the emission of corpuscular or electromagnetic radiations. ra·di·o·nu·clide n. evaluation of bile diversion by Braun enteroenterostomy: prevention and treatment of alkaline reflux gastritis: an alternative to Roux-en-Y diversion. Ann Surg 1994;219:458-466. 11. Kingsnorth AN, Berg JD, Gray MR. A novel reconstructive technique for pylorus-preserving pancreaticoduodenectomy: avoidance of early postoperative gastric stasis stasis /sta·sis/ (sta´sis) 1. a stoppage or diminution of flow, as of blood or other body fluid. 2. a state of equilibrium among opposing forces. . Ann R Coll Surg Engl 1993;75:38-42. 12. McCallum RW, Polepalle SC, Schirmer B. Completion gastrectomy for refractory gastroparesis following surgery for peptic ulcer disease: long-term follow-up with subjective and objective parameters. Dig Dis Sci 1991;36:1556-1561. 13. Karlstrom L, Kelly KA. Roux-Y gastrectomy for chronic gastric atony atony /at·o·ny/ (at´ah-ne) lack of normal tone or strength; flaccidity.aton´ic at·o·ny or a·to·ni·a n. Lack of normal tone or tension; flaccidity. atony see atonia. . Am J Surg 1989;157:44-49. 14. Shellito PC, Warshaw AL. Idiopathic intermittent gastroparesis and its surgical alleviation. Am J Surg 1984;48:408-412. 15. Svedlund J, Sullivan M, Liebman B. Long term consequences of gastrectomy for patient's quality of life: the impact of reconstructive techniques. Am J Gastroenterol 1999;94:438-445. 16. Liebman B, Svedlund J, Sullivan M, et al. Symptom control may improve food intake, body composition, and aspects of quality of life after gastrectomy in cancer patients. Dig Dis Sci 2001;46:2673-2680. 17. Ishihara K. Long term quality of life in patients after total gastrectomy. Cancer Nurs 1999;22:220-227. 18. Abell TL, Minocha A. Gastroparesis and the gastric pacemaker. J Miss State Med Assoc 2002;43:369-375. 19. Abell T, Lou J, Tabbaa M, et al. Gastric electrical stimulation for gastroparesis improves nutritional parameters at short, intermediate, and long-term follow-up. JPEN JPEN Joint Protection Enterprise Network JPEN Journal of Parenteral & Enteral Nutrition 2003;27:277-281. 20. Grenfield LJ, Mulholland MW, Oldham KT. et al. Surgery: Scientific Principles and Practice, Philadelphia, Lippincott-Raven Publishers, 1997, ed 2, pp 771-773. Benton Oubre, MD, Jean Luo, MD, Amar Al-Juburi, MD, Guy Voeller, MD, Babajide Familoni, PHD, and Thomas L. Abell, MD From University of Mississippi Medical Center University of Mississippi Medical Center (UMC) is the health sciences campus of the University of Mississippi (Ole Miss). Located in Jackson, Mississippi (USA), it houses the Schools of Medicine, Dentistry, Nursing, Health Related Professions, and Graduate Studies in the Health , Jackson, MS; University of Tennessee-Memphis, Memphis, TN; University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) is part of the University of Arkansas System, a state-run university in the U.S. state of Arkansas. The main campus is located in Little Rock. , Little Rock, AR; and University of Memphis The University of Memphis is a public research university located in Memphis, Tennessee, United States, and is a flagship public research university of the Tennessee Board of Regents system. , Memphis, TN. Reprint requests to Thomas L. Abell, MD, Division of Digestive Diseases, University of Mississippi Medical Center, 2500 North State Street, Jackson, MS 39216. Email: tabell@medicine.umsmed.edu Accepted March 3, 2005. Medtronic has a license with University of Tennessee The University of Tennessee (UT), sometimes called the University of Tennessee at Knoxville (UT Knoxville or UTK), is the flagship institution of the statewide land-grant University of Tennessee public university system in the American state of Tennessee. Research Corp, and Dr. Thomas Abell and Dr. Guy Voeller were employees of the University of Tennessee. Dr. Babajide Familoni was an employee of the University of Memphis. Parts of this paper were previously published as abstracts: Luo J, Abell TL, Eaton P, et al. Gastric electrical stimulation rapidly improves both GI symptoms and gastric emptying in patients with "post-surgical" gastroparesis. Gastroenterol 1999;116:A1332; Al-Juburi A, Oubre B, Lahr C, et al. Gastric electrical stimulation (GES) is still effective when combined with other surgical therapies. Neurogastroenterol Motil 2002;14:433, presented at the 12th Biennial Meeting of American Motility motility /mo·til·i·ty/ (mo-til´ite) the ability to move spontaneously.mo´tile Motility Motility is spontaneous movement. Society, Galveston, TX, Sept 19-22, 2002; Al-Juburi A, Oubre B, Lahr C, et al. Gastric electrical stimulation (GES) is still effective when combined with colectomy colectomy /co·lec·to·my/ (ko-lek´tah-me) excision of the colon or of a portion of it. co·lec·to·my n. Surgical removal of part or all of the colon. . Am J Gastroenterol 2002;97:S119, presented at American College of Gastroenterology The American College of Gastroenterology (ACG) is a Bethesda, Maryland-based medical association of gastroenterologists. The association was founded in 1932 and holds annual meetings and regional postgraduate continuing education courses, establishes research grants, 67th Annual Scientific Meeting, Seattle, WA, Oct 18-23, 2002. RELATED ARTICLE: Key Points * Gastric electrical (neural) stimulation (GES) differs from gastric pacing. * Postsurgical patients have not been treated long-term with GES. * Six consecutive postsurgical patients were treated with GES for up to 4 years. * Patients had improvement in symptoms, gastric emptying, and health-related quality of life.
Table 1. Patient demographics and duration of illness
Patients (n)
Total no. of patients 6
Age (years)
Mean 38.7
Range 35-44
Sex
Male 2
Female 4
Duration of original illness (years)
Mean 6.7
Range 2.0-13.0
Gastric electrical stimulation implant (months)
Mean 45.6
Range 5.0-90.0
Table 2. Follow up of symptoms, quality of life, and gastric emptying of
patients with surgery-associated gastroparesis (a)
Baseline Temp %
No. of patients 6 5
VFS 3.2 [+ or -] 0.6 0.4 [+ or -] 0.4 (b) 87
TSS 36.5 [+ or -] 2.7 12.3 [+ or -] 5.7 (c) 66
HRQOL 13.2 [+ or -] 2 NA
2 H S GET 76.8 [+ or -] 13 52 [+ or -] 14 32
4 H S GET 71.4 [+ or -] 14 41.6 [+ or -] 16 42
1 H L GET 73.6 [+ or -] 7 52.6 [+ or -] 11 28
2 H L GET 60.2 [+ or -] 9 27 [+ or -] 6.5 55
3 months % 6 months %
No. of patients 6 6
VFS 0.9 [+ or -] 0.5 (c) 72 1.3 [+ or -] 0.4 (c) 59
TSS 10.4 [+ or -] 3.8 (b) 72 12.5 [+ or -] 6.6 (c) 66
HRQOL 7.7 [+ or -] 2 (c) 42 7.2 [+ or -] 2 (c) 45
2 H S GET 67 [+ or -] 11 12 54.7 [+ or -] 22 29
4 H S GET 41 [+ or -] 9 43 36.7 [+ or -] 31 49
1 H L GET 63.3 [+ or -] 7 14 42.3 [+ or -] 19 42
2 H L GET 46.3 [+ or -] 10 23 30.7 [+ or -] 16 49
12 months % Latest %
No. of patients 3 5
VFS 0.3 [+ or -] 0.3 (b) 90 1.4 + 0.6 (c) 56
TSS 8.5 [+ or -] 4.8 (c) 76 20.5 [+ or -] 4 (c) 44
HRQOL 6 [+ or -] 1 (c) 54 7.3 [+ or -] 1 (c) 45
2 H S GET 50 [+ or -] 20 34 63.7 [+ or -] 9 18
4 H S GET 15 [+ or -] 11 (c) 79 30 [+ or -] 4 (c) 58
1 H L GET 40.7 [+ or -] 9 (c) 44 NA NA
2 H L GET 24.7 [+ or -] 11 (c) 59 NA NA
(a) %, Percent improvement from baseline; VFS, vomiting frequency score;
TSS, gastrointestinal total symptom score; HRQOL, health-related quality
of life; H S, hour/solid; H L, hour/liquid; GET, gastric emptying test;
NA, not applicable.
(b) P < 0.01, significant.
(c) P < 0.10, borderline significant.
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