Normal Oral Intake Research Articles

Transthoracic Collis-Nissen repair for massive type IV paraesophageal hernia

An 80-year-old woman presented with type IV massive hiatal hernia with intrathoracic upside-down stomach and transverse colon. She was dyspneic and vomited upon consuming food or water. Consequently, she developed aspiration pneumonia. Both esophagoscopy and upper gastrointestinal series demonstrated significant cephalad displacement of the gastroesophageal junction. A Collis-Nissen hernial repair by muscle-sparing mini-thoracotomy was performed successfully. To date, 3 years after surgery, the patient is enjoying normal oral intake, has an excellent activities of daily living level, and there is no hernia recurrence. Cases of massive paraesophageal hernia are frequently associated with esophageal shortening that causes tension on the repairs and late failure. Advantages of the transthoracic approach in such cases include feasibility of direct esophageal mobilization, accurate assessment of esophageal tension, and facilitation of Collis gastroplasty. The true indication for transthoracic Collis-Nissen repair among cases of paraesophageal hiatal hernia with a short esophagus should be acknowledged more in the era of laparoscopy.

Cytomegalovirus-related neutropenic enterocolitis with negative CMV antigenemia as the initial presentation in an acute myeloid leukemia patient

Dear Editor, A 35-year-old gentleman, with the past history of diabetes mellitus for 2 years, was transferred to our hospital in 2007 because of cecal enterocolitis with septic shock and pancytopenia. Fever and right lower quadrant (RLQ) abdominal pain without nausea, vomiting, or diarrhea developed 8 days before admission, and he visited another hospital 3 days after onset of symptoms. Pancytopenia with absolute neutrophil count of 250/mL was detected at that time, and abdominal computed tomography (CT) scan revealed prominent wall thickening with submucosal edematous change in cecum and ascending colon. Although broad-spectrum antibiotics were used for several days, abdominal pain and pancytopenia persisted. So, he was transferred to our hospital. On admission, the patient was mildly febrile (37.8°C); physical examination showed distended abdomen with a tenderness over RLQ. Laboratory findings disclosed: white blood cell count, 5.0×10/l (absolute neutrophil count 300/mL, segment 3%, band 3%, blast 15%, atypical lymphocyte 74%), hemoglobin, 11.5 g/dl; platelet, 44× 10/l; C-reactive protein, 156.7 mg/l. After bone marrow exam, acute monocytic leukemia (M5b) was diagnosed. Cefepime, metronidazole, and IV fluid support for bowel rest were given for his neutropenic enterocolitis. He received induction chemotherapy with the regimen, idarubicin 12 mg/m/day for 3 days, and cytarabine 100 mg m day for 7 days. However, fever, abdominal pain, and RLQ tenderness with abdominal fullness persisted even after white blood cell count recovered from nadir. There was no diarrhea or bloody stool during the course. Blood cultures, urinalysis, and stool cultures all yielded negative results. Serology test was negative for anti-HIV. Abdominal CT scan was repeated and revealed thickening of cecal wall with peri-colic inflammation. Because typhlitis with ileus persisted under conservative treatment, he underwent right hemicolectomy. Histological examination of the cecum showed: (1) ulceration and necrotic debris over the mucosal wall of cecum; (2) some enlarged cells with eosinophilic nuclear inclusions (Fig 1.) which were positive for cytomegalovirus (CMV) stain by CMV monoclonal antibody (clone CMV 01, Neomarkers; Fig. 2). The diagnosis of typhlitis with CMV infection was made. CMV-pp65 antigenemia assay, as determined by immunofluorescence, was negative. Three weeks of Ganciclovir was added. No more fever or abdominal pain was noted after operation, and the patient recovered gradually with normal oral intake. Neutropenic enterocolitis or typhlitis is a clinical syndrome in neutropenic patients characterized by fever and abdominal pain. It was originally described in children following induction chemotherapy for acute leukemia [1] and subsequently reported in both adults and children with a variety of hematologic and solid malignancy, in patients with acquired immunodeficiency syndrome, and as a complication of bone marrow transplantation [2]. The development of typhlitis has historically been attributed to a variety of chemotherapeutic regimens. Mucosal injury caused by cytotoxic drugs combined with neutropenia and impaired host defense to intestinal organism leads to the occurrence of typhlitis [3]. However, in this patient, neutropenic enterocolitis is the initial presentation of acute leukemia before treatment of any chemotherapeutic agents Ann Hematol (2009) 88:279–280 DOI 10.1007/s00277-008-0596-3

Palliation in Patients with Malignant Gastric Outlet Obstruction with the Newly Designed WallFlex Duodenal Stent: First Data of a Multicenter, Prospective Trial

Background: Self-expandable metal stents (SEMS) are being increasingly used to palliate malignant stenoses of the gastric outlet and proximal small bowel. The reported short-term (30-day) clinical success and complication rates of this new enteral stent made of nitinol (Boston Scientific WallFlex™ Duodenal Stent) were excellent. The purpose of our study was to evaluate technical and clinical success of this device as well as complications in the medium-term follow-up. Methods: To evaluate efficacy of the stent, associated to obstruction relief and the ability to have satisfactory quality of diet, considering satisfactory diet as soft solids or normal diet. Gastric outlet obstruction symptoms were graded according to a well defined scoring system (GOOSS). From 11/16/06 until 11/06/07 54 prospective patients were enrolled into the study in 8 german referral centers. There were 31 female and 23 male patients, median age 72.6 years (48-94). Data were collected from charts and endoscopy procedure reports. The follow-ups where done at 15 days, 1 month, 3 months, 6 months, 9 months by clinical visits or personal interview by phone. Results: Primary stent placement was successful in 51 patients (technical success, 94.4%) and a total of 56 stents were placed. Two patients received a second stent. In 1 patient the stent migrated during the deployment and in another patient the stent did not cover the stricture completely. The short term (within 30 days) clinical success rate was 98% (53/54) with 55% (29/53) patients able to tolerate normal oral intake without obstructive symptoms. Median follow-up was 4.1 months. The mean survival was 71.5 days (range 2-216) and 30 patients died in the follow-up due to tumor progression. No death was stent related. 3-months-follow-up data was available in 16 patients and all were able to eat: 9 were able to take normal diet (56.3%); 6 soft diet (37.5%), and 1 liquid diet (6.2%). Minor complications occurred in 10 patients (5.4%): pain (7), migration (1), stent obstruction (1) and melena (1). Conclusion: Placement of this newly designed self-expandable WallFlex duodenal stent is clinically effective in patients with unresectable gastric outlet or duodenal obstruction. Also in the long run this device appears to be effective and relatively safe.

The use of self-expanding silicone stents in esophageal cancer care: optimal pre-, peri-, and postoperative care

Preoperative nutritional supplementation, management of esophageal leaks, and postoperative anastomotic strictures still remain common problems in the management of esophageal cancer. Jejunal feeding tubes, total parenteral nutrition (TPN) with nasogastric suction, and repeated esophageal dilations remain the most common treatments, respectively. The aim of this study was to evaluate the use of removable silicone stents in (1) the preoperative nutritional optimization during neoadjuvant therapy, (2) the management of perioperative anastomotic leak, and (3) the management of postoperative anastomotic strictures. Review of our prospectively maintained esophageal database identified 15 patients who had removable self-expanding silicone stents placed in the management of one of these three management problems from July 2004 to August 2006. Preoperative therapy: Five patients underwent initial stent placement in preparation for neoadjuvant therapy. Dysphagia relief was seen in 100% of patients, with optimal caloric needs taken within 24 h of placement. All patients tolerated neoadjuvant therapy without delay from dehydration or malnutrition. One stent migration was found at the time of operation, which was removed without sequelae. Perioperative therapy: Five patients developed delayed (>10 days) esophageal leaks that were managed with removable esophageal stent and percutaneous drainage (in three patients). All patients had successful exclusion of the leak on the day of the procedure with resumption of oral intake on the evening of procedure. All five healed leaks without sequelae. Postoperative therapy: Five patients developed postoperative anastomotic strictures that required dilation and placement of removable esophageal stent. The median number of dilations was 1 (range 1-2), with all stents placed for approximate 3 months duration. All patients had immediate dysphagia relief after stent placement. Removable esophageal stents are novel treatment option to optimize relief of symptoms and return the patients back to a more normal oral intake. Continued evaluation is needed to consider stent use as first-line therapy.

Clinical application prospects of gastric pacing for treating postoperative gastric motility disorders

Similar to the heartbeat, gastric peristalsis is regulated by an electrical rhythm generated by a pacemaker. Thus, electrical dysrhythmia of gastric slow waves will inevitably affect gastric peristalsis and emptying. The recurrence of postoperative gastroparesis is thereby closely related to the abnormalities of electrical dysrhythmia and ectopic pacemakers, resulting in postoperatively persistent gastric motility disorders in some severe cases, despite the use of prokinetic and antiemetic drugs. Recent studies have demonstrated that gastric pacing, analogous to pacing the human heart, is an attractive and promising therapy that is both feasible and safe. Gastric pacing has been shown to be strikingly effective in normalizing gastric dysrhythmia, increasing the activity of the gastric slow wave and thereby prompting gastric dynamia and emptying. Furthermore, the long-term utilization of gastric pacing can (i) relieve patients from clinical symptoms, such as nausea and vomiting; (ii) release patients with severe postoperative gastroparesis from relying on prokinetic drugs and the jejunal feeding tube; (iii) return patients to normal oral nutritional intake and provide a more satisfactory nutritional status and most importantly; and (iv) give patients a better quality of life. Overall, research focused on gastric pacing has demonstrated excellent prospects for clinical application in the treatment of postoperative gastroparesis disorders, especially for those unresponsive to prokinetic drugs.

Minimally Invasive Surgery for Achalasia: Combined Experience of Two European Centers

The present report summarizes 12 cases with achalasia treated with laparoscopic Heller myotomy and anterior fundoplication according to the method of Thal and Dor. From 1997 to 2005 at 2 institutions in Europe, 12 patients (7 male and 5 female, ages ranging from 3.5 to 7 years) were treated for esophageal achalasia (EA) with laparoscopic Heller myotomy and anterior fundoplication according to Thal and Dor. In 1 case a perforation of the esophageal mucosa occurred, which was promptly treated during surgery. Follow-up ranged from 18 to 60 months and included clinical examination and barium radiography of the upper digestive tract. Postoperatively, 10 patients showed a normal weight curve and complete resolution of symptoms. All patients showed complete regression of digestive and respiratory symptoms from the first examination, with a normal oral meal intake and an improvement of weight and height parameters. One case required repeat intervention after 2 years because of persisting pain; in this case surgery revealed an insufficient myotomy. Modified extramucosal Heller cardiomyotomy associated with 180 degree anterior antireflux plastic surgery (according to Thal and Dor's procedures) is a useful and safe procedure in the treatment of EA in pediatric patients. Our data, which are supported by long-term follow-up, also stress the relevance of anterior fundoplication in preventing postoperative gastroesophageal reflux.

Stepped assessment of gastric emptying of a solid meal using the 13C-octanoic acid breath test

The (13)C-octanoic acid breath test is widely used for evaluating gastric emptying of solids. Since the results of this test are influenced by multiple factors such as the time required to grind the solid meal into smaller particles, the gastroduodenal transport time of the ground meal, and the time required for bowel drug absorption and drug dispersion, the administration of a test meal by the oral route alone cannot result in an accurate measurement of the complicated process of emptying the stomach of solids. The aim of the present study was to evaluate each phase of gastric emptying of solids by varying the administration route of the test meal. Six healthy male volunteers (mean age: 33.2 yr) participated in the study. The test meal consisted of a bowl of rice topped with a mixture of boiled chicken and eggs admixed with 100 mg of (13)C-octanoic acid (total: 273 kcal). All subjects were given the test meal by each of the following three methods: 1. Normal oral intake of the test meal, 2. Feeding of the ground test meal through a nasogastric tube, 3. Feeding of the ground test meal through a duodenal tube. For each set of examinations, the mean residence time (MRT), half-emptying time (T(1/2)), gastric emptying coefficient (GEC), lag phase (L-breath), and measured maximum (13)C excretion time (Tmax-measured) were calculated. The data was analyzed to determine the time for each phase of gastric emptying as follows: mean grinding time (MGT) = MRT(oral) - MRT(nasogastric), mean gastroduodenal transport time (MGDTT) = MRT(nasogastric) - MRT (nasoduodenal). Data was expressed as the mean +/- SE. The values of the parameters of MGT were 0.82 +/- 0.50 hr (MRT), 0.64 +/- 0.18 hr (T(1/2)), 0.51 +/- 0.24 hr (L-breath), -0.45 +/- 0.30 hr (GEC), and 49.2 +/- 8.0 min (Tmax-measured). The values of the parameters of MGDTT were 0.87 +/- 0.38 hr (MRT), 0.26 +/- 0.29 hr (T(1/2)), 0.92 +/- 0.36 hr (L-breath), 0.55 +/- 0.23 hr (GEC), and 63.33 +/- 8.16 min (Tmax-measured). The times required for the drug absorption and disposition were 1.60 0.20 hr (MRT), 1.03 +/- 0.24 hr (T(1/2)), 0.10 +/- 0.08 hr (L-breath), 3.72 +/- 0.46 hr (GEC), and 19.67 +/- 2.11 min (Tmax-measured). By varying the administration route of a test meal containing (13)C-octanoic acid, we may be able to assess each phase of the emptying of gastric solids in detail, thus leading to a better understanding of gastroduodenal motility.

Appearance of Individual Amino Acid Concentrations in Arterial Blood During Steady‐State Infusions of Different Amino Acid Formulations to ICU Patients in Support of Whole‐Body Protein Metabolism

Previous work has demonstrated a relationship between arterial amino acid concentrations and uptake of amino acids across peripheral tissues in healthy volunteers, as well as in chronically and acutely ill patients. The aim of the present study was to evaluate whether different amino acid profiles in commercially available amino acid formulations are translated into significantly different arterial amino acid concentrations presumably high enough to promote protein metabolism in intensive care unit (ICU) patients. Nonprotein calories (60% glucose: 40% lipid) were simultaneously and constantly infused over 72 hours. Different free amino acid solutions were infused at random to each patient for 24 hours in order to determine the appearance of steady-state arterial concentrations of individual amino acids. Basal metabolic and nutrition states were defined after a 12-hour infusion period with glucose in each patient. Healthy volunteers receiving a standardized oral meal served as reference subjects in measurements of venous amino acid concentrations after normal oral food intake. The sum of all amino acids in arterial plasma increased significantly during steady-state infusions of all the free amino acid solutions vs basal state in ICU patients. Only glutamine, taurine, and tyrosine did not increase at all vs basal state during steady-state infusions of the 3 formulations. Alanine, arginine, citrulline, glycine, histidine, serine, methionine, phenylalanine, valine, and ornithine showed different concentration among the amino acid solutions during infusions. Healthy volunteers had significantly higher overall concentrations of amino acids in both fasted and fed state compared with ICU patients, which indicates that free amino acid solutions remain a limiting component in artificial nutrition to patients to promote arterial amino acid concentrations in the artificially fed state. It appears important to continue further improvement of composition profile in solutions of free amino acids to promote adequate uptake across organ beds in promotion of protein balance in artificially nourished patients.

Problems Experienced by Patients Receiving Parenteral Nutrition at Home: Results of an Open Interview Study

Home parenteral nutrition (HPN) is offered to patients who are unable to absorb sufficient nourishment from normal oral food intake or tube feeding. Major causes include severe motility disorders and limited resorption surface in the small intestine. HPN is a lifesaving therapy but has severe consequences on daily life. The aim of this study was to make an inventory of the problems experienced by patients receiving HPN. Open interviews were held with 48 patients from the 2 major centers for HPN in the Netherlands, centered around the question: Which 3 HPN problems have the most severe impact on your daily life? Data were analyzed using content analysis. The respondents mentioned 7 central problems: negative emotions, physical problems, social limitations, dependence on others, incapability, complications, and patient-care provider problems. In addition, practical problems were mentioned: sleeping problems, financial problems, and the "hospital atmosphere" at home. The latter issues formed less of a problem for the patients. The main underlying elements in the lives of many HPN patients appeared to be loss, longing, and grief. In contrast, a smaller proportion of the patients expressed that they had clearly adapted to life with HPN. By means of the HPN, they were still alive and enjoying all the things they could still do.

ESPEN Guidelines on Enteral Nutrition: Cardiology and Pulmonology

These guidelines are intended to give evidence-based recommendations for the use of enteral nutrition (EN) in patients with chronic heart failure (CHF) and chronic obstructive pulmonary disease (COPD). They were developed by an interdisciplinary expert group in accordance with officially accepted standards and are based on all relevant publications since 1985. They have been discussed and accepted in a consensus conference. EN by means of oral nutritional supplements (ONS) or tube feeding (TF) enables nutritional intake to be maintained or increased when normal oral intake is inadequate. No data are yet available concerning the effects of EN on cachexia in CHF patients. However, EN is recommended to stop or reverse weight loss on the basis of physiological plausibility. In COPD patients, EN in combination with exercise and anabolic pharmacotherapy has the potential to improve nutritional status and function. Frequent small amounts of ONS are preferred in order to avoid postprandial dyspnoea and satiety as well as to improve compliance.

Hypophosphatemia in Living Liver Donors

Background and aim Some patients who undergo donor hepatectomy for adult living donor liver transplantation develop hypophosphatemia postoperatively. Since this imbalance appears to be a factor in postoperative complications, some authors advocate routine supratherapeutic phosphorus repletion. The purpose of this study was to determine the frequency of hypophosphatemia after elective donor lobectomy for liver transplantation and to assess whether phosphorus repletion is necessary in this patient group. Methods The cases of 26 patients who donated 19 right lobe and seven left lateral lobe grafts between August 2004 and March 2005 were evaluated. Postoperative phosphorus levels and other relevant data were obtained from our institution’s transplant database. Presence/severity of hypophosphatemia was categorized as follows: normal (>2.5 mg/dL), mild (1.5 to 2.5 mg/dL), moderate (1.1 to 1.5 mg/dL), and profound (<1.0 mg/dL). Results No patients undergoing donor hepatectomy suffered profound or life-threatening hypophosphatemia and no donor required hyperalimentation for phosphate repletion. Twenty one donors (80.7%) did not have postoperative hypophosphatemia. In addition there appears to be no increased morbidity related to hypophosphatemia. A left lateral segment donor (3.8%) had moderate hypophosphatemia that alleviated with oral intake gradually. Four patients (15.5%; three of right lobe donor, one of left lateral segment donor) had mild hypophosphatemia. We also appropriately corrected the hypophosphatemia with encouragement of normal oral intake. By postoperative day 5, essentially all donor phosphorus levels were corrected to normal range. Conclusions The results suggest that hypophosphatemia after donor hepatectomy is not as common as previously reported. We find that appropriate early oral intake postoperatively effectively prevents/minimizes hypophosphatemia in patients who undergo donor hepatectomy.

The use of perioperative antibiotics in tonsillectomy: Does it decrease morbidity?

To assess the efficacy of perioperative antibiotics in decreasing post-operative morbidity among patients undergoing tonsillectomy or adenotonsillectomy. Meta-analysis based on a structured search of the literature, using MEDLINE and the Cochrane database. Only articles, which included both treatment and control groups, were included in the final analysis. Studies were limited to ones that involved human subjects, including both children and adults. Studies using steroids and topical antibiotics were excluded. Articles were abstracted for patient factors, elements of study design, methods of patient assignment to treatment and control groups, and clinical outcomes. The primary outcome, time required for return to normal oral intake, was analyzed in the final meta-analysis. Four hundred and twenty-eight articles were initially identified. There were 23 potentially appropriate articles. Of these, 18 were able to be located in full text form and in English. Seven of these studies directly studied the efficacy of perioperative antibiotics (versus no antibiotics) in decreasing post-operative morbidity. Four studies had sufficient information to calculate effects estimates (xi) and standard deviations (Si) for the primary outcome. Three studies either did not report the outcome of interest or did not report a measure of stability (e.g. p-value or confidence interval). The data available from the first four studies were combined in a quantitative meta-analysis. Statistical analyses were performed using STATA for Windows software. The pooled estimate indicated that the antibiotic group returned to normal oral intake, on average, 1 day sooner than the controls. This difference was found to be statistically significant with a 95% confidence interval of 0.5-1.6 days. An additional assessment of three qualitative reports also suggested the use of perioperative antibiotics for adenotonsillectomy was associated with less post-operative pain. However, studies varied in terms of study quality, sample size, outcome examined, measure used and antibiotic administered. Definitive conclusions regarding the effect of perioperative antibiotics on other outcomes including bleeding, halitosis, fever, activity level and nausea and vomiting could not be drawn due to the small numbers of studies. In this meta-analysis, the use of perioperative antibiotics in patients who have had tonsillectomy or adenotonsillectomy appears to be associated with a 1-day reduction in the time required for return to normal oral intake. For other potentially important outcomes, such as post operative pain or bleeding, sufficient data were not available to make any definitive conclusions regarding the effect of perioperative antibiotics.

Magnetic Airway Implants for the Treatment of Obstructive Sleep Apnea Syndrome

To evaluate repelling magnetic implants to treat obstructive sleep apnea (OSA) using a canine model. Magnetic forces equivalent to effective CPAP were estimated with benchtop studies. An acute canine model was used to simulate pharyngeal collapse. Tolerance, safety, and stability of the implants were evaluated in a chronic series of 10 dogs observed over 6 months. Equivalence to CPAP (10-12 cm H(2)O) was achieved with low-force (<10 g/cm length), light (approximately 2 gram) implants. Magnetic implants prevented airway collapse in the acute canine. Normal behavior, swallowing, and oral intake were noted in the chronic canine over 6 months. Implant extrusion was 10%. Histology showed fibrous encapsulation without chronic inflammation. Repelling magnets successfully maintained a patent airway and were well tolerated in the canine. Repelling magnets could represent an implantable alternative to CPAP if human studies reveal similar findings.

Portal Vein Cavernoma Associated with Goldenhar Syndrome

Portal Vein Cavernoma Associated with Goldenhar Syndrome

Gastric Electrical Stimulation

Gastric electrical stimulation is an alternative to gastrectomy in patients with refractory gastroparesis. Retrospective case series with a median follow-up of 20 months. A tertiary care university hospital and a university-affiliated community hospital. Twenty-nine patients (22 women, 7 men; median age, 39 years; age range, 20-87 years) with debilitating gastroparesis who were referred for gastrectomy from December 10, 2001, through October 1, 2004. Twenty-four patients had type 1 diabetic gastroparesis and 5 patients had idiopathic gastroparesis. Placement of a gastric stimulator device laparoscopically in 24 patients and by laparotomy in 5 patients. Morbidity and mortality of the procedure, symptom control, hospital readmissions, need for supplemental nutritional support, body mass index (calculated as weight in kilograms divided by the square of height in meters), and gastric emptying. Follow-up results were available in 27 patients. There was no 30-day mortality or morbidity in 4 patients. The median hospital stay was 3 days. All of the patients tolerated an oral diet at discharge. Symptom control was excellent to good in 19 patients. Nutritional support was discontinued in the 19 patients who were dependent on supplemental feeding before the procedure (P<.001). The median body mass index improved significantly (22.9 preoperatively vs 25.1 postoperatively; P = .006). The median gastric emptying rate (percentage per minute) was measured in 15 of the 27 patients postoperatively and showed significant improvement (0.17% per minute preoperatively vs 0.38% per minute postoperatively; P<.001). Additional procedures were required in 4 patients (owing to poor outcome in 3 patients). Gastric electrical stimulation ameliorated symptoms, returned patients to normal oral nutritional intake, increased body mass index, improved gastric emptying rates, and is an alternative to gastrectomy in patients with end-stage gastric disease.

Surgical Utility of a New Carbon Dioxide Laser Fiber: Functional and Histological Study

The objective was to investigate the functional and histological properties of surgical procedures using a new carbon dioxide (CO2) laser fiber. In vitro and in vivo animal models. In vitro experiments using porcine true vocal cord and arytenoid cartilage were designed to study the histological effects of using a photonic band-gap fiber assembly for CO2 laser energy delivery. Continuous and pulsed-wave settings at different wattages were tested. In vivo endoscopic surgery on canine larynges and buccal mucosa were performed to examine functional and short-term healing when performing photonic band-gap fiber assembly-assisted laser surgery. In vitro experiments showed consistent cutting with the photonic band-gap fiber assembly using either straight or 90 degrees bent-tip fibers. The surrounding tissue in these experiments showed little collateral thermal damage with the average range of thermal width from 14.1 to 18.8 microm in vocal cords and from 5.2 to 10.5 microm in cartilage. Similarly, thermal depth ranged from 28.0 to 350.0 microm in vocal cords and from 269.7 to 739.6 microm in cartilage. In vivo experiments demonstrated ease in maneuvering and flexibility for cutting. There was minimal blood loss, smoke plume, or carbonaceous debris. There were no postprocedural complications. Normal oral intake was noted on postprocedural day 1. There was no evidence of stridor or respiratory distress. Seven days after the procedure, re-epithelialization was complete in the buccal incisions and nearly completed in the laryngeal incisions. The photonic band-gap fiber assembly produced reliable results in cutting with functional characteristics representing an improvement over current technology. The device shows promise as an effective tool for minimally invasive procedures that are amenable to use of the CO2 laser.

Esophageal stents as a salvage therapy for non-malignant iatrogenic esophageal perforations

Esophageal non-malignant perforations are severe life-threatening conditions. The current treatment is either surgical or conservative. We report a case series of 3 consecutive patients (1 female, 2 male; 34-68 years) treated with expandable covered stents for non-malignant iatrogenic esophageal perforations. In our series, 3 out of 3 patients sealed their perforations and resumed normal oral intake. Complications observed were 2 stent migrations, which occurred at 6 and 11 months after stent insertion, a stenosis due to acid reflux treated by another stent insertion above the first one. On the basis of the data available, it appears that esophageal stents was successful in 82% of the cases. The mortality and complication rates were of 7% and 32% respectively. The main complications observed were peptic stenosis above the stent and fistulas. These results are promising but need to be confirmed in large-scale prospective studies. Mediastinal drainage remains mandatory when sepsis is present.

Randomized phase IV trial of oral tegafur and low dose leucovorin versus intravenous 5-fluorouracil and leucovorin in the treatment of advanced colorectal cancer (ACC): Final results

3547 Background: In a previous phase II trial in ACC, an all-oral regimen of Tegafur and Leucovorin obtained an overall response rate of 30% (Cancer,1998;83:254–8). We conducted a multicenter randomized equivalence trial in patients with ACC, to compare oral Tegafur (FT) + Leucovorin (LV) with the Mayo schedule. Methods: Patients with locally advanced or metastatic colorectal adenocarcinoma who were not candidates for radical therapy, were randomly assigned to treatment if they had KPS ≥ 60%, measurable or evaluable disease, adequate bone marrow, liver and renal function, and normal oral intake. Arm 1: LV (20 mg/m2 intravenous) followed by 5FU (425 mg/m2 intravenous) daily for 5 days every 4 weeks for 3 cycles then every 5 weeks. Arm 2: oral FT (750 mg/m2 daily for 21 days) and oral LV (15 mg/m2 every 8 hours) every 28 days. Treatment was maintained until disease progression or toxicity. Primary end points were objective response (OR) and overall survival (OS). Secondary objectives included time to progression (TTP), toxicity and QOL. Results: 237 (123 Arm 1, 114 Arm 2) of the 290 planned patients from 16 centers were randomized and evaluated. Patient characteristics were well balanced between the two arms. OR and OS rates are summarized in the table. Median TTP in Arms 1 and 2 was 189 (95% CI: 166–212) and 181 days (95% CI: 163–199), respectively. Grade III/IV toxicities were neutropenia (4.1 vs. 0%) asthenia (5% vs. 10.5%), diarrhea (14% vs. 18.4%), stomatitis (7.4 vs. 6.1%), nausea (0.8% vs. 3.5%) and vomiting (2.5% vs. 4.4%). Delays and dose reductions were more frequent in Arm 2. Conclusions: The results show that FT+LV was comparable to 5-FU on all primary and secondary study endpoints, making it a valid alternative to the 5-FU intravenous schedule in these patients. Oral Tegafur should be tested in combination with other treatments . No significant financial relationships to disclose.

Randomized phase IV trial of oral tegafur and low dose leucovorin versus intravenous 5-fluorouracil and leucovorin in the treatment of advanced colorectal cancer (ACC): Final results

3547 Background: In a previous phase II trial in ACC, an all-oral regimen of Tegafur and Leucovorin obtained an overall response rate of 30% (Cancer,1998;83:254–8). We conducted a multicenter randomized equivalence trial in patients with ACC, to compare oral Tegafur (FT) + Leucovorin (LV) with the Mayo schedule. Methods: Patients with locally advanced or metastatic colorectal adenocarcinoma who were not candidates for radical therapy, were randomly assigned to treatment if they had KPS ≥ 60%, measurable or evaluable disease, adequate bone marrow, liver and renal function, and normal oral intake. Arm 1: LV (20 mg/m2 intravenous) followed by 5FU (425 mg/m2 intravenous) daily for 5 days every 4 weeks for 3 cycles then every 5 weeks. Arm 2: oral FT (750 mg/m2 daily for 21 days) and oral LV (15 mg/m2 every 8 hours) every 28 days. Treatment was maintained until disease progression or toxicity. Primary end points were objective response (OR) and overall survival (OS). Secondary objectives included time to progression (TTP), toxicity and QOL. Results: 237 (123 Arm 1, 114 Arm 2) of the 290 planned patients from 16 centers were randomized and evaluated. Patient characteristics were well balanced between the two arms. OR and OS rates are summarized in the table. Median TTP in Arms 1 and 2 was 189 (95% CI: 166–212) and 181 days (95% CI: 163–199), respectively. Grade III/IV toxicities were neutropenia (4.1 vs. 0%) asthenia (5% vs. 10.5%), diarrhea (14% vs. 18.4%), stomatitis (7.4 vs. 6.1%), nausea (0.8% vs. 3.5%) and vomiting (2.5% vs. 4.4%). Delays and dose reductions were more frequent in Arm 2. Conclusions: The results show that FT+LV was comparable to 5-FU on all primary and secondary study endpoints, making it a valid alternative to the 5-FU intravenous schedule in these patients. Oral Tegafur should be tested in combination with other treatments . No significant financial relationships to disclose.

Ophthalmic pain following vitrectomy: an audit of current practice

Current local practice for patients undergoing vitrectomy involves general anaesthesia with or without topical analgesics, with regular simple analgesics and opioid-based analgesics as required postoperatively. No local anaesthetic eye blocks are currently inserted. A literature search on Medline revealed no trials comparing local anaesthetic eye blocks with oral and topical analgesia. We reviewed local practice to assess whether it might be beneficial to use local anaesthetic blocks to improve analgesia after vitrectomy. Patients undergoing vitrectomy were seen pre-operatively and given a questionnaire enquiring about anxiety levels and expectations of pain. The patients were followed up postoperatively and further questionnaires enquired about analgesia given intraoperatively; postoperative nausea and vomiting; time to eating and drinking; and pain scores. The patients were asked to take further questionnaires home to assess pain relief on the second and third postoperative days. Pain was assessed using verbal scoring. Over the one-month period a total of 15 patients were recruited. Response rate was 80% (12/15). Pain was found to be worst on day 1 and minimal by day 3. Five out of 12 patients reported moderate to severe pain on day 1. This was associated with nausea and vomiting in four cases. Of these, three patients received opioid-based analgesics such as codeine and tramadol. In the group reporting no pain or mild discomfort (seven cases), no patient received opioid analgesics. Patients who complained of nausea and vomiting (four cases) had an average time to eating and drinking of 3.56 h compared to 2.21 h in the group without nausea and vomiting (eight cases). There was a positive relationship between anxiety levels pre-operatively and pain scores postoperatively (Pearson correlation coefficient 0.86). Present standards of analgesia appear unsatisfactory. The simple analgesics used are inadequate in a large proportion of cases. Patients with higher pain scores are those who are more anxious pre-operatively, for whom opioid analgesics are prescribed and who complain of nausea and vomiting with a longer period before normal oral intake is resumed. This may have implications for certain patient groups (e.g. diabetics). Introduction of local anaesthetic eye blocks in addition to regular simple analgesics such as paracetamol and NSAIDs might reduce pain scores over the initial difficult 24 h. Use of opioid-based analgesics should be avoided if possible, as these seem to increase the incidence of postoperative nausea and vomiting.