Gastric Stasis Research Articles

Treatment of gastric ulcer by highly selective vagotomy without a drainage procedure: an interim report.

Abstract Fourteen patients with gastric ulcer alone and 5 patients with combined gastric and duodenal ulceration- have been treated by highly selective (parietal-cell) vagotomy without a drainage procedure (H.S.V.) the past 3 years. Before operation no evidence of gastric stasis was found, clinically, radiologically, or during tests of gastric secretion. Spontaneous acid out was low. Acid output in response to a test meal of meat extract was also found to be low. There no evidence that in the patients with gastric ulcer alone the ulcer was due to pyloric channel disease with excessive release of gastrin by the antrum. Each gastric ulcer was proved by frozen-section examination to be benign at the time of operation. Problems with gastric stasis were encontered in early postoperative period. The vagotomy was shown to be complete on insulin testing in each of 17 patients tested. Follow-up ranges from 1 month to 3 years. The clinical progress of the patients has been good, and has symptoms suggestive of recurrent ulceration gastric retention. Barium-meal examination in 11 patients who were follwed up for more than 9 months showed satisfactory gastric emptying, without recurrent ulceration. While the need for much longer follow-up is obvious, these preliminary results are encouraging. Further trial of H.S.V. for gastric ulcer, preferably in the form of a prospective, randomized comparison with Billroth-I gastrectomy, now seems desirable.

The value of preserving the pylorus in the surgery of duodenal ulcer.

Abstract Highly selective vagotomy without a drainage procedure (H.S.V.) has been use in the surgical treatment of 120 cases of duodenal ulcer in Leeds over the past 3 years. In this operation preservation of the vagal nerve-supply to the antral region of the stomach permits preservation of an intact pylorus. In the present paper the results which have been achieved are assessed, both clinically and experimentally, by comparison with the results in patients after truncal or selective vagotomy and pyloroplasty at a comparable stage after operation. Studies of gastric emptying provide no evidence of gastric stasis after H.S.V., and symptoms of flatulence and food vomiting are found no more frequently than after vagotomy and pyloroplasty. After both truncal and selective vagotomy and pyloroplasty gastric emptying and small-bowel transit were abnormally fast, whereas after H.S.V. there was much less departure from the values found in preoperative ulcer patients. At the clinical and experimental level dumping and diarrhoea were singnificantly less frequent after H.S.V. than after vagotomy and pyloroplasty. To date there has been no operative mortality, no case of recurrent ulcer, and no reoperation for gastric stasis after H.S.V. Preservation of a more normal pattern of gastric emptying, by reducing the incidence of dumping, diarrhoea, and bile vomiting, has led to better overall (Visick) results after H.S.V. than after truncal or selective vagotomy and pyloroplasty.

Bile reflux and gastric emptying in patients with combined gastric and duodenal ulceration.

Measurements of duodenogastric reflux of bile and gastric emptying of a 5 per cent glucose liquid test meal have been made in 8 patients with combined gastric and duodenal ulcers and the results compared with those found in 21 patients with a diagnosis of uncomplicated duodenal ulceration. It was not possible to demonstrate any differences between the two groups of patients in respect of these studies and it is suggested that gastric stasis and duodenogastric reflux may not be important factors in the aetiology of combined ulcer disease.

Anterior highly selective vagotomy with posterior truncal vagotomy: a simple technique for denervating the parietal cell mass.

Abstract Anterior highly selective vagotomy with posterior truncal vagotomy was performed in a consecutive series of 20 patients with uncomplicated chronic duodenal ulcer. After identification of the vagal trunks the anterior leaf of the lesser omentum was separated from the lesser curve of the stomach, carefully preserving the anterior nerve of Latarjet. The distal extent of the dissection was from a point approximately 7–8 cm from the pylorus. After ensuring that all branches of the anterior nerve passing to the lesser curve had been severed, the trunk of the posterior nerve was divided and a segment removed. The lower 6–7 cm of oesophagus were cleared of nerve fibres. All the patients recovered well from the operation and none suffered from prolonged gastric stasis in the postoperative period. Fourteen patients are well and free of symptoms (follow-up 3–15 months). Four patients have a sense of epigastric fullness and one of these vomits occasionally. Three patients have been troubled periodically by diarrhoea and one has ulcer-type pain although no recurrence has been seen on endoscopy or on barium meal examination. One week after surgery the mean percentage reduction was 73 per cent in basal acid output and 65 per cent in peak acid output after stimulation with pentagastrin. Five of the patients had late positive insulin tests; 3 of these were the first 3 patients in the series. The other patients were insulin negative. In 10 patients the pattern of gastric emptying of a radionuclide-labelled meal 6 months after surgery was compared with that of 23 controls. The mean half-emptying time was similar in the two groups (71·7 ± 10·1 min v. 71·3 ± 3·8 min). It is concluded that this new and simpler operation is technically feasible and it may be worth a cautious trial in centres with a special interest in this type of surgery.

The influence of an intact pylorus on postprandial enteroglucagon and neurotensin release after upper gastric surgery.

Upper partial gastrectomy for carcinoma of the gastric cardia or fundus is unavoidably accompanied by truncal vagotomy, so it is orthodox practice to carry out pyloroplasty with this procedure. In order to assess the effect of leaving an intact pylorus in this operation, 21 patients were investigated with an oral hypertonic load (200 ml 50 per cent glucose solution), and blood was taken at intervals during the test, for the ileal gut hormones, enteroglucagon and neurotensin, as well as for measurements of haematocrit and blood glucose. Clinical features of dumping during the test were sought. There were 7 patients with upper partial gastrectomy, truncal vagotomy and an intact pylorus, 7 patients without a pylorus (total or near total gastrectomy) and 7 patients not subjected to gastric surgery. No significant difference was found in any of the measurements between gastrectomy patients with an intact pylorus and those draining through an enterostomy. However, both these groups differed significantly from normal controls in having greater rates of rise and higher peak values of enteroglucagon, neurotensin, haematocrit and blood glucose, together with a more frequent occurrence of dumping symptoms during the test. As the above measurements probably reflect transit of glucose into the small intestine, the findings in this study suggest that leaving an intact unstenosed pylorus is unlikely to lead to gastric stasis following upper partial gastrectomy.

The effect of vagotomy and drainage operations on the rate of gastric emptying in duodenal ulcer patients

Abstract The rate of gastric emptying was estimated in 29 patients with duodenal ulcers, before and after vagotomy and drainage operations, by measuring the disappearance from the stomach of a standard meal containing radioactive chromium. When Heineke-Mikulicz pyloroplasty accompanied vagotomy gastric emptying was observed to be slowed, whereas after vagotomy and Fitmey pyloroplasty the rate of gastric emptying was more rapid when compared with the preoperative rate. Gastric emptying after vagotomy and gastrojejunostomy showed no consistent alteration in rate. Temporary gastric stasis occurred in the early postoperative period after vagotomy and drainage procedures.

Proximal gastric vagotomy: Follow-up at 10–20 years

From August 1969 to December 1989, 600 patients had elective proximal gastric vagotomy for duodenal ulceration with an operative mortality of 0.2 per cent. Of these, 372 patients had surgery over 10 years ago. Three hundred and forty-two patients survived for more than 10 years and, in a prospective study, 305 were reviewed, forming the basis of this 10-20-year follow-up report. Forty-six (15 per cent) have had recurrent ulceration; 80 per cent of these developed symptoms within 5 years and no patient has had recurrence after 13 years. Although 29 patients required reoperation for recurrent ulceration, the current patient satisfaction rate for Visick grades I and II is 92 per cent. Only two patients required reoperation because of gastric stasis. It is concluded that proximal gastric vagotomy is a safe and satisfactory first choice operation for duodenal ulceration.

Role of pyloroplasty in the retrosternal stomach: Results of a prospective, randomized, controlled trial

A prospective, randomized, controlled trial comparing clinical outcome and emptying of a solid meal from the retrosternal stomach, with and without pyloroplasty is described. Forty consecutive patients with oesophageal cancer undergoing retrosternal gastric reconstruction of the oesophagus were studied. In 20 patients the pylorus was left intact (group 1) and 20 patients underwent an Aust pyloroplasty (group 2). Nine patients in group 1 suffered postoperative symptoms of gastric stasis compared with only one patient in group 2 (P = 0.0106). Three patients in group 1 died from aspiration pneumonia before discharge from hospital. A gastric emptying test was performed on 24 patients between 1 and 3 months after surgery. By this time, most survivors had recovered from symptoms attributed to gastric stasis and no significant difference in gastric emptying could be demonstrated between the two groups. Selection of patients, a wide range of emptying times and improvement in gastric emptying on follow-up may explain the lack of correlation between postoperative symptomatology and the gastric half-emptying times. A pyloroplasty is advised to prevent the potentially lethal effects of gastric stasis in the early postoperative period following retrosternal reconstruction of the oesophagus.

Anterior lesser curve seromyotomy and posterior truncal vagotomy for chronic duodenal ulcer: the results at five years.

In one surgical unit, 241 patients have undergone anterior gastric seromyotomy and posterior truncal vagotomy for chronic duodenal ulcer. The postoperative mortality rate was 0.4 per cent. Four patients (1.6 per cent) required a drainage procedure for gastric stasis. The first 66 patients (Group A) were followed prospectively and 58 were available for assessment at 5 years. Eight patients (14 per cent) had developed a recurrent ulcer. In seven of these patients this responded to conservative treatment with H2 receptor antagonists. One patient has required Polya partial gastrectomy for recurrent ulceration. At 5 years 47 patients (81 per cent) were placed in the Visick I or II categories. In the next 175 patients (Group B), the ulcer recurrence rate was 3 per cent, suggesting a learning curve in mastering the procedure. We conclude that the immediate and 5-year results of the first 66 patients are at least comparable with those of highly selective vagotomy. Anterior gastric seromyotomy with posterior truncal vagotomy is an easy and rapid procedure and may be more widely applicable than highly selective vagotomy.

SYSTEMATIC APPRAISAL OF NUTRITIONAL SUPPORT IN PATIENTS UNDERGOING PANCREATICODUODENECTOMY

Introduction: Pancreaticoduodenectomy (PD) represents a distinct surgical procedure in terms of resumption of post-operative feeding: the retention of the stomach or part of the stomach combined with loss of the intestinal pacemaker cells of Cahal is known to result in alteration of gastrointestinal motility. The aim of the present study is to undertake systematic, structured appraisal of the available literature in order to identify whether consistent themes emerge and thus aid the generation of evidence-based guidelines for post-operative nutrition in patients undergoing PD. Methods: Searches of the MEDLINE and EMBASE databases for the period January 1994 to November 2004 yielded 4 studies providing discretely analyzable data on outcome in 571 patients undergoing PD. Data were retrieved on: pre-operative weight loss, biochemical parameters type and duration of nutritional support and clinical outcome. Results: The optimal route of delivery of enteral nutrition(EN) is unestablished. NJ feeding tubes may avoid the risks of surgical jejunostomy but can dislodge and can be a source of post-operative discomfort. % loss of pre-illness body weight was similar in all studies. TPN was associated with a greater risk of post-operative morbidity in all trials in which it was used. EN is associated with a lower incidence of infective complications but there was no additional benefit from I-EN. There is evidence for prolonged requirement for NG intubation in patients receiving post-operative jejunal feeding as compared to controls not receiving EN (15.1 vs 3.4 days; P < 0.01). Cyclical nutrition with periods of fasting was associated with a lower incidence of post-operative gastric stasis. Conclusions: Clear themes to emerge are that pre-operative weight loss is widespread, post-operative EN (either via NJ or jejunostomy) is the preferred route and that there is no conclusive evidence in favour of I-EN. These results can be synthesised to produce contemporary evidence-based guidelines for nutritional support in patients undergoing PD.

Gastroparesis After a Pylorus-Preserving Pancreatoduodenectomy

Gastroparesis after a pylorus-preserving pancreatoduodenectomy has two main aspects, namely early gastric stasis and subsequent postprandial delayed gastric emptying. Early gastric stasis producing an excessive amount of gastric juice during the immediate postoperative period might be caused by the absence of phase III activity of the gastric migrating motor complex (MMC), and such symptoms usually subside within a month or two. Subsequent postprandial delayed gastric emptying leading to belching, fullness of the stomach, nausea, and vomiting after the resumption of oral intake normally continues for up to 6 months before complete recovery. There are many possible mechanisms to explain these phenomena. The early recovery of phase III of the MMC does not necessarily predict an early relief of postprandial delayed gastric emptying, thus suggesting that these two phenomena are caused by various mechanisms. The phenomena, mechanisms, and treatment strategies for gastroparesis after pylorus-preserving pancreatoduodenectomy are described in this review.

Acute akinesia in Parkinson disease

To assess acute akinesia in patients with Parkinson disease (PD) ("acute akinesia" defined as a sudden deterioration in motor performance that persists for > or =48 hours despite treatment). The study population was a cohort of 675 patients followed regularly for 12 years in the authors' outpatient clinic. All patients were studied when acute akinesia led to hospitalization. Unified Parkinson's Disease Rating Scale (UPDRS) scores were rated during the akinetic state and compared with ratings obtained 1.6 +/- 0.9 months before the onset or after recovery. Twenty-six patients developed acute akinesia; in 17 of the 26 patients, new akinetic symptoms first manifested at the onset of an infectious disease or after surgery and appeared unrelated to changes in treatment or altered levodopa kinetics. In nine patients, acute akinesia developed concurrently with gastrointestinal diseases or drug manipulations showed features of neuroleptic malignant syndrome. Acute akinesia severe enough to increase the UPDRS Motor Subscale score by 31.4 +/- 12.8 appeared within 2 to 3 days and persisted for 11.2 +/- 6.2 days despite attempts to increase the dopaminergic drug dose or administer continuous subcutaneous apomorphine infusion. Symptomatic recovery began 4 to 26 days after the onset of acute akinesia and appeared incomplete in 10 patients. Four patients of 26 died despite treatment. Levodopa kinetics were normal in all patients without gastrointestinal disease and in one patient with gastric stasis. Acute akinesia is a life-threatening complication of Parkinson disease (PD). It is unlike the "wearing-off" phenomenon that occurs when dopaminergic drug levels decline and responds to dopaminergic rescue drugs. Acute akinesia may be a clinical entity distinct from the previously described PD motor fluctuations.

Two replicate randomized, double-blind, placebo-controlled trials of the time to onset of pain relief in the acute treatment of migraine with a fast-disintegrating/rapid-release formulation of sumatriptan tablets

Background: The gastric stasis that commonly accompanieBackground:722 migraine headache may impair absorption of conventional oral tablets in the stomach. A fast-disintegrating/rapid-release formulation of sumatriptan has been developed to enhance tablet disintegration and drug dispersion and potentially improve absorption. Objective: Two studies were conducted comparing the time to onset of relief from moderate or severe migraine pain with the fast-disintegrating/rapid-release formulation of sumatriptan tablets 50 and 100 mg and placebo. Methods: These were 2 identically designed randomized, double-blind, parallel-group studies. Sumatriptan 50 or 100 mg or placebo was taken on an outpatient basis to treat a single moderate or severe migraine attack. Using a personal digital assistant, patients recorded the time of dosing and the time at which pain severity reached none or mild (ie, pain relief) or none (ie, pain free) in real time so that the time to onset of relief could be measured as a continuous variable. Onset of relief was defined as the earliest time point at which a statistically significant difference in pain relief compared with placebo was achieved and maintained through 2 hours after dosing. Before dosing and at pre-determined time points after dosing, patients also provided an assessment of migraine pain as none, mild, moderate, or severe. At a clinic visit within 1 week after treatment of the migraine attack, patients were queried about adverse events. For each adverse event, investigators recorded whether study medication was considered the cause. Data analyses were undertaken for each study individually and, in post hoc analyses of the primary and key secondary end points, on pooled data from both studies. Results: The 2 studies comprised 2696 patients: 902 received sumatriptan 50 mg, 902 received sumatriptan 100 mg, and 892 received placebo. Patients' mean age ranged from 40.2 to 40.8 years across treatment groups, and most patients were female (83%–87%) and white (92%–93%). In the analysis of pooled data, sumatriptan tablets provided significantly more effective pain relief compared with placebo as early as 20 minutes after dosing with the 100-mg dose and as early as 30 minutes after dosing with the 50-mg dose ( P ≤ 0.05). Similar results were observed for the individual studies: in study 1, sumatriptan tablets were significantly more effective than placebo at 25 minutes with the 100-mg dose and at 50 minutes with the 50-mg dose; in study 2, sumatriptan tablets were significantly more effective than placebo at 17 minutes for the 100-mg dose and at 30 minutes for the 50-mg dose ( P ≤ 0.05). In the pooled data, the cumulative percentages of patients with pain relief by 2 hours after dosing were 72% for the 100-mg dose and 67% for the 50-mg dose, compared with 42% for placebo ( P ≤ 0.001, both sumatriptan doses vs placebo). The cumulative percentages of patients with a pain-free response by 2 hours were 47% for the 100-mg dose, 40% for the 50-mg dose, and 15% for placebo ( P ≤ 0.001, both sumatriptan doses vs placebo). In the individual studies, significantly more patients receiving either sumatriptan dose were migraine free 2 hours after dosing and had sustained pain relief and a sustained pain-free response over 24 hours compared with placebo ( P ≤ 0.001, both sumatriptan doses vs placebo). The only drug-related adverse events reported in >2% of patients in any treatment group in either study were nausea (both studies: 3% sumatriptan 100 mg, 2% sumatriptan 50 mg, 1% placebo) and paresthesia (study 1: <1% sumatriptan 100 mg, <1% sumatriptan 50 mg, 0% placebo; study 2: 3% sumatriptan 100 mg, 1% sumatriptan 50 mg, <1% placebo). Conclusions: In these studies, sumatriptan tabletConclusions:722 in a fast-disintegrating/rapid-release formulation were effective for the acute treatment of moderate to severe migraine pain, were generally well tolerated, and achieved an onset of pain relief as early as 20 minutes for 100 mg and as early as 30 minutes for 50 mg.

TNF&amp;#945; Modulation of Visceral and Spinal Sensory Processing

The cytokine tumor necrosis factor(alpha) (TNF(alpha)) is associated with a constellation of physiological and behavioral characteristics that follow in response to infection such as fever, fatigue, listlessness, loss of appetite, malaise, and tactile hypersensitivity. These responses are examples of central nervous system (CNS) functions modified by the activated immune system. Our studies have focused on the involvement of TNF(alpha) in CNS control of gastrointestinal function and "visceral malaise". We have demonstrated that TNF(alpha) can elicit gastric stasis in a dose-dependent fashion via its interaction with vago-vagal neurocircuitry in the brainstem. Sensory elements of the vago-vagal reflex circuit (i.e., neurons of the solitary tract [NST] and area postrema [AP]) are activated by exposure to TNF(alpha), while the efferent elements (i.e., dorsal motor neurons of the vagus [DMN]) cause gastroinhibition. Transient exposure to low doses of TNF(alpha) cause potentiated (exaggerated) NST responses to stimulation. Subsequent studies suggest that TNF(alpha) presynaptically modulates the release of glutamate from primary afferents to the NST. Using immunohistochemical studies, we have observed the constitutive expression of the TNFR1 receptor on central vagal afferents and spinal trigeminal afferents in the medulla, as well as on cells and afferent fibers within the dorsal root ganglia and within laminae I and II of the dorsal horn throughout the spinal cord. The constitutive presence of these receptors on these afferents may explain why inflammatory or infectious processes that generate TNF(alpha) can disrupt gastrointestinal functions and cause tactile hypersensitivity. These receptors may also play a critical role in the chronic allodynia and hyper-reflexia observed after spinal cord injury or peripheral nerve damage.

A Novel Technique for Post-pyloric Feeding Tube Placement in Critically Ill Patients: A Pilot Study

Delivery of enteral nutrition in critically ill patients is often hampered by gastric stasis necessitating direct feeding into the small intestine. Current techniques for placement of post-pyloric feeding catheters are complex, time consuming or both, and improvements in feeding tube placement techniques are required. The Cathlocator is a novel device that permits real time localisation of the end of feeding tubes via detection of a magnetic field generated by a small electric current in a coil incorporated in the tip of the tube. We performed a pilot study evaluating the feasibility of the Cathlocator system to guide and evaluate the placement of (1) nasoduodenal feeding tubes, and (2) nasogastric drainage tubes in critically ill patients with feed intolerance due to slow gastric emptying. A prospective study of eight critically ill patients was undertaken in the intensive care unit of a tertiary hospital. The Cathlocator was used to (1) guide the positioning of the tubes post-pylorically and (2) determine whether nasogastric and nasoduodenal tubes were placed correctly. Tube tip position was compared with data obtained by radiology. Data are expressed as median (range). Duodenal tube placement was successful in 7 of 8 patients (insertion time 12.6 min (5.3-34.4)). All nasogastric tube placements were successful (insertion time 3.4 min (0.6-10.0)). The Cathlocator accurately determined the position of both tubes without complication in all cases. The Cathlocator allows placement and location of an enteral feeding tube in real time in critically ill patients with slow gastric emptying. These findings warrant further studies into the application of this technique for placement of post-pyloric feeding tubes.

Critical Pathway for Operable Gastric Cancer

Purpose: Critical pathways (CP), also known as clinical pathways, are management plans that display goals for patients and have led to improved outcomes for many disease entities. This study was aimed at developing a critical pathway for the surgical treatment of gastric cancer patients and evaluating its usefulness. Materials and Methods: A CP was developed and implemented by a team of surgeons, nurses, nutritionists, and administrative officials. Among the 117 patients who received curative gastrectomies for gastric cancer at Kangnam St. Mary's Hospital, The Catholic University of Korea, between October 2003 and August 2004, 26 patients were treated according to the CP. We evaluated its usefulness by comparing the clinical characterisctics, postoperative progress, hospital stays, and costs between the CP and the non-CP groups. Patient satisfaction was also surveyed with questionnaires. Results: Of the initial 26 patients in the CP group, two were excluded from the final evaluation; one patient had a duodenal stump leakage, and the other had a gastric stasis postoperatively. In 8 patients, protocol violation occurred; six patients refused to be discharged on the postoperative day, one patient who had an gastric staisis postoperatively stayed for 2 additional days, and one patient who needed ICU care stayed for 4 additional days. The drop-out rate was (2/26), and the variance rate was (8/26). The mean hospital stay was 11.3 days ( days) for the CP group compared with 17.5 days ( days) for the non-CP group, resulting in a difference of about 6 days (P days) and 8.3 days ( days) for the non-CP and the CP groups, respectively, but the difference was statistically not significant (P>0.05). The mean charge during the hospital stay was higher in the non-CP group ( 6,292,200) than in the CP group ( 4,863,685). The charge per hospital day was higher in the CP group ( 430,414) than in the non-CP group ( 359,554). Patient satisfaction was higher in the CP group than in the non-CP group. Conclusion: By developing and applying a critical pathway in the surgical treatment of stomach cancer patients, we could reduce the length of hospital stay as well as the cost. A multi-centered prospective study to establish a standard treatment pathway and to demonstrate its effectiveness is needed in the future.

Actinobacillus Capsulatus Septicemia in a Domestic Rabbit (Oryctolagus Cuniculus)

A 5-year-old pet rabbit (Oryctolagus cuniculus) died after a 3-day history of anorexia and depression. At necropsy, the stomach was distended with dough-like ingesta and hair consistent with gastric stasis syndrome. The lungs had multifocal, raised red nodules with circumferential hemorrhage. Microscopic examination showed pulmonary hemorrhage with intravascular fibrin thrombi and bacterial colonies, which were present in lesser amounts in the kidney, heart, and liver. Bacterial culture of the lung produced a heavy pure growth of Actinobacillus capsulatus. Acute septicemia is a novel presentation for this pathogen. This is the first documented case of A. capsulatus disease in the contiguous United States and may represent an underdiagnosed to emerging disease of lagomorphs.

Clinical application of clip-assisted endoscopic method for nasoenteric feeding in patients with gastroparesis and gastroesophageal wounds

To report the clinical experiences in the application of clip-assisted endoscopic method for nasoenteric feeding in patients with gastroparesis and patients with gastroesophageal wounds, and to compare the efficacy of nasoenteric feeding in these two indications. From April 2002 to January 2004, 21 consecutive patients with gastroparesis or gastroesophageal wounds were enrolled and received nasoenteric feeding for nutritional support. A clip-assisted method was used to place the nasoenteric tubes. Outcomes in the two groups were compared with respect to the successful rate of enteral feeding, percentage of recommended energy intake (REI), and complication rates. The gastroparesis group included 13 patients with major burns (n = 7), trauma (n = 2), congestive heart failure (n = 2) and post-surgery gastric stasis syndrome (n = 2). The esophageogastric wound group included eight patients with tracheoesophageal fistula (n = 2) and wound leakage following gastric surgery (n = 6). Two study groups were similar in feeding successful rates (84.6% vs 75.0%). There were also no differences in the percentage of REI between groups (79.4% vs 78.6%). Additionally, no complications occurred in any of the study groups. Nasoenteric feeding is a useful method to provide nutritional support to most of the patients with gastroparesis who cannot tolerate nasogastric tube feeding and to the cases who need bypass feeding for esophageogastric wounds.

Effects of a fast disintegrating/ rapid release oral formulation of sumatriptan on functional ability in patients with migraine

SUMMARYBackground: A new oral form of sumatriptan has been developed to facilitate tablet disintegration and drug dispersion and to mitigate the effects of gastric stasis that can accompany migraine.Objective: To evaluate the effects on functional ability of the new fast disintegrating/rapid release formulation of sumatriptan.Methods: Sumatriptan 50 mg (n = 137), 100 mg (n = 142), or placebo (n = 153) was administered early when pain was mild for the acute treatment of a single migraine attack in a randomized, double-blind, parallel-group, placebo-controlled clinical trial. For this report, main health-outcomes endpoints (which were secondary endpoints for this clinical trial that was primarily designed to assess pain-free efficacy) included functional ability measured through 2 h postdose on a 5-point scale and lost time equivalents, a composite measure of migraine-associated time missed from activities, and reduced effectiveness at activities through 24 h postdose.Results: Normal functional ability was restored in a significantly ( p < 0.05) greater percentage of patients treated with sumatriptan than placebo beginning 45 min postdose for sumatriptan 100 mg and 1 h postdose for sumatriptan 50 mg. During the 24 h after initial dosing, the median (range) lost time equivalents for the combination of paid work activities and activities outside of paid work were significantly lower in the groups treated with sumatriptan (1.1 [0–10] sumatriptan 100 mg; 0.8 [0–36] sumatriptan 50 mg) compared with placebo (2.9 [0–24]) ( p ≤ 0.01 each sumatriptan group versus placebo). The corresponding mean ± SD values for lost time equivalents were 1.9 ± 2.3 and 2.5 ± 4.7 for sumatriptan 100 mg and 50 mg, respectively, compared with 3.5 ± 4.3 for placebo.Conclusion: A new oral sumatriptan formulation confers rapid, sustained restoration of functional ability in the acute treatment of migraine so that patients can return rapidly to normal functioning at work and outside of work.

Brazilian multicenter study of the intragastric balloon.

Intragastric balloons have been used in obese patients to provide early satiety and thereby induce weight loss. Several studies have reported promising results with a new balloon (BIB((R))) designed to overcome some of the technical pitfalls of earlier devices. We assessed both safety and effectiveness of the BIB((R)). From November 2000 to February 2004, 483 overweight and obese patients were treated with the BIB((R)). 323 patients completed a 6-month follow-up, and 85 of them completed a 1-year follow-up. All patients took part in a multidisciplinary program involving clinical, psychiatric, physical training, and dietary approaches. Compared to baseline values, after a 6-month follow-up subjects showed significant reductions in weight (15.2 +/- 10.5 kg), percent excess weight loss (48.3 +/- 28.1), and BMI (-5.3 +/- 3.4 kg/m(2)) (P < 0.000). At 1-year follow-up, 85 patients have maintained more than 90% of their BMI reduction. The main side-effects were nausea/vomiting (40%), and epigastric pain (20%), requiring removal of the BIB (R) in 11 patients (3.4%). Minor complications were reflux esophagitis (12%) and symptomatic gastric stasis (9%). Balloon impaction occurred in 2 cases (0.6%), and in 1 patient (0.3%) there was spontaneous deflation of the balloon leading to a small-bowel obstruction solved by a surgical approach. The BIB((R)) has been effective to temporarily control obesity, inducing an excess weight loss of approximately 48%. It was not associated with mortality and showed minimal risk of major complications.