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Biomedical subjects

Richard I Rothstein

Publications and source records attributed to Richard I Rothstein.

12 recordsLinked to original sources
PubMed2006

Safety and tolerability of transoral Bravo capsule placement after transnasal manometry using a validated conversion factor.

OBJECTIVES: To prospectively calculate and validate a conversion factor in healthy volunteers that allows accurate nonsedated, transoral (TO) Bravo capsule placement after transnasal (TN) manometry, and to evaluate the ease and safety of nonendoscopic Bravo placement compared with endoscopic placement. METHODS: Part 1. Twenty-five healthy volunteers underwent sequential TN and TO esophageal manometry to measure the distance to the lower esophageal sphincter (LES). A TN to TO conversion factor was calculated from these measurements. Part 2. Twenty volunteers underwent TN manometry followed by unsedated TO Bravo capsule placement using the conversion factor calculated in part 1. TN endoscopy then measured the location of the Bravo capsule in relationship to the squamocolumnar junction (SCJ). Part 3. During an 18-month period, 370 consecutive patients referred for a Bravo procedure underwent nonendoscopic, unsedated TO placement (308 patients) or standard endoscopically assisted placement (62 patients). RESULTS: Part 1. All 25 volunteers completed TN and TO manometry; a conversion factor of 4 cm was calculated. Part 2. Using the calculated conversion factor of 4 cm, a Bravo capsule was deployed TO 5 cm above the proximal border of the LES. The mean +/- standard deviation (SD) TN endoscopic distance to the capsule was 6.0 cm (+/-0.3 cm) above the SCJ. Part 3. A total of 333 patients completed the entire study (90%). Analysis of 48-h pH measurements did not reveal any significant differences between the two groups. CONCLUSIONS: A reliable and valid conversion factor of 4 cm following TN manometry permits accurate TO placement of the Bravo capsule without endoscopy. TO, unsedated Bravo placement is safe, well tolerated, and may minimize costs and potential risks associated with endoscopy.

Adolescent↗
PubMed2006

Sedationless upper endoscopy.

The use of sedation with peroral passage of conventionally sized endoscopes for upper endoscopy is the standard practice for most endoscopists in the United States. The administration of sedatives requires time-consuming and resource-intensive patient monitoring, has substantial cost, and can produce side effects and rare complications. Ultra-thin videoendoscopes (outer diameter less than 6 mm) have been developed, can easily be passed transorally or transnasally without sedation, and have been shown to be well tolerated and accurate. Unsedated upper endoscopy can provide an efficient, cost-effective alternative to standard endoscopy, should be useful for endoscopic screening, and can be offered as an option to conventional sedated examination.

Endoscopes, Gastrointestinal↗
PubMed2006

Sedationless upper endoscopy.

The use of sedation with peroral passage of conventionally sized endoscopes for upper endoscopy is the standard practice for most endoscopists in the United States. The administration of sedatives requires time-consuming and resource-intensive patient monitoring, has substantial cost, and can produce side effects and rare complications. Ultra-thin videoendoscopes (outer diameter less than 6 mm) have been developed, can easily be passed transorally or transnasally without sedation, and have been shown to be well tolerated and accurate. Unsedated upper endoscopy can provide an efficient, cost-effective alternative to standard endoscopy, should be useful for endoscopic screening, and can be offered as an option to conventional sedated examination.

Endoscopes, Gastrointestinal↗
PubMed2005

Endoscopic therapy for gastroesophageal reflux disease.

Within the last 15 years, novel endoscopic therapies have been developed as options for patients who have gastroesophageal reflux disease (GERD). These approaches can provide long-term relief of GERD, or can be used to "bridge" patients to future therapy, because undergoing treatment does not preclude one from future medical or surgical therapy. These therapies continue to bean active source of research and investigation. Although they are undergoing rapid development, there are only a few peer-reviewed articles detailing original studies with short-term follow-up. Future success in this arena will depend on sham-controlled trials, long-term outcome studies, and cost-effectiveness analyses. This article describes available endoscopic therapies, discusses their effectiveness and duration of response, and reviews their failures and complications.

Biocompatible Materials↗
PubMed2004

Symptoms and treatment burden of gastroesophageal reflux disease: validating the GERD assessment scales.

BACKGROUND: A comprehensive assessment instrument that measures the burden of both symptoms and treatment is needed to determine the optimal management of gastroesophageal reflux disease (GERD), and we developed such an instrument. METHODS: This validation study included 3 groups: patients with active GERD (n = 193), surgical patients with prior GERD (n = 197), and general medical outpatients (n = 63). All completed an initial survey. General medical patients and patients with active GERD were resurveyed after 2 to 6 weeks. The main outcome measures were test-retest reliability, internal consistency, discriminant validity, and responsiveness to change for 3 scales graduated from 0 to 100: a GERD burden (or overall impact on quality of life scale), a symptoms scale, and a treatment scale. Higher scores indicated greater disease burden. RESULTS: The GERD burden, symptoms, and treatment scales all demonstrated good discriminant validity, as patients in the active-GERD group had the highest scores. Scores on each scale effectively classified the patients who belonged to the active-GERD group. Moreover, scores improved substantially 8 weeks after surgery, thereby demonstrating the scales' responsiveness to change. As hypothesized, the burden of treatment was distinct from that of symptoms, as 23% of patients not bothered by GERD symptoms described their GERD treatment to be a moderate or serious problem. Indeed, the impact of treatment problems approached that of symptoms problems. All pairwise comparisons were significant (P<.02). CONCLUSIONS: The GERD burden, symptoms, and treatment scales were valid, reliable, and responsive instruments for use in patients with GERD. Our analyses highlight the importance of assessing both symptoms and treatment burden in patients with GERD.

Cost of Illness↗
PubMed2004

A randomized, controlled comparison of ibuprofen at the maximal over-the-counter dose compared with prescription-dose celecoxib on upper gastrointestinal mucosal injury.

BACKGROUND & AIMS: Ibuprofen is a well-tolerated nonsteroidal anti-inflammatory drug (NSAID), particularly at over-the-counter (OTC) doses. Cyclooxygenase 2 (COX-2)-selective inhibitors cause less ulceration than prescription-dose nonselective NSAIDs. We compared endoscopic injury related to nonprescription ibuprofen doses with celecoxib, also comparing prescription doses of naproxen with placebo as a positive control. METHODS: The study was a randomized, placebo-controlled, double blind, double-dummy endoscopic evaluation with concealed allocation. A 2-way crossover with a 4-5-week washout period was used. Participants were healthy adults with normal baseline findings from endoscopy. Ninety-five subjects were randomly assigned, and 79 subjects completed both study phases. Age distribution was reflective of the target population of the OTC agent. Twenty percent were infected with Helicobacter pylori, and 79% and 67% had a current or past medical problem, respectively. Qualifying subjects, stratified by the presence or absence of H. pylori infection (n = 20), were randomly assigned to 1 of the 4 sequences (phase I/II) as follows: ibuprofen/celecoxib; celecoxib/ibuprofen, naproxen/placebo, or placebo/naproxen. Primary end points were the frequency of endoscopic ulcers and erosions in the groups administered: (1) celecoxib vs. ibuprofen and (2) naproxen vs. placebo. RESULTS: In celecoxib-treated subjects, 2.6% developed ulcers compared with 17.9% of those treated with ibuprofen (P = 0.056). Naproxen treatment was associated with a significantly greater ulceration rate compared with placebo. CONCLUSIONS: Short-term use of the nonselective COX inhibitors ibuprofen and naproxen is associated with a greater risk for endoscopic mucosal injury compared with the COX-2-selective inhibitor celecoxib or placebo. A prospective analysis appropriately powered to address the incidence of clinically significant gastroduodenal ulceration associated with the short-term use of these agents would be required to further define the clinical relevance of these findings.

Adolescent↗
PubMed2003

Endoscopic suturing for gastroesophageal reflux disease: clinical outcome with the Bard EndoCinch.

From a review of the single peer reviewed published report and the brief preliminary studies presented in abstract form, the BARD EndoCinch procedure seems safe and demonstrates an acceptable efficacy for symptom control during short-term follow-up. Most patients (about 2 out of 3) do well with improvement of GERD symptoms during the first post-procedural year. This benefit may wane over time. Objective benefit is lacking with the minority of treated individuals achieving normalization of 24-hour total acid exposure, and no significant effect has been seen in healing of esophagitis. This may focus the treatment towards that group of GERD patients with mild or non-erosive disease. The authors have no information that the endoscopic therapy could prevent reflux-related complications, and long-term data is awaited from accumulated clinical experience to establish the maintenance profile of this novel treatment. The outcomes from the sham trial, and long-term follow-up data will help to define the role of this anti-reflux therapy. The authors need additional studies to define the effect of endoluminal plication on the function of the lower esophageal sphincter to optimize its benefit for patients.

Clinical Trials as Topic↗
PubMed2003

Determining an appropriate threshold for referral to surgery for gastroesophageal reflux disease.

BACKGROUND: Persistent symptomatic gastroesophageal reflux disease (GERD) can be treated with medication or surgery. The purposes of this study were (1) to determine how poor the quality of life on medication would need to be to justify assuming the risks of surgery, and (2) to estimate the proportion of patients currently on medication whose quality of life is below this value. METHODS: We developed a Markov decision analysis model to simulate health outcomes (measured in quality adjusted life years [QALY]) over 10 years for medication and surgery in patients with typical GERD symptoms. We included probabilities of events obtained from a systematic literature review. Quality of life adjustments, expressed as utilities, were drawn from a survey of 131 patients 1 to 5 years after antireflux surgery. By using this model, we calculated what quality of life on medications would change the optimal strategy from medication to surgery (threshold). To determine the proportion of patients below this value, we prospectively surveyed 40 medically treated GERD patients at our hospital. RESULTS: Surgery resulted in more QALYs than medical therapy when the utility with medication use was below 0.90. Sensitivity analysis showed this value to be relatively insensitive to reasonable variations in surgical risks (mortality, failures, reoperation) and quality of life after surgery. Among those surveyed on medications, 48% fell below this threshold and would be predicted to benefit from surgery. CONCLUSION: Our model suggests that surgery would likely benefit a high proportion of medically treated GERD patients. Individual assessment of quality of life with GERD should be considered to aid clinical decision making.

Data Collection↗
PubMed2003

Risk of early surgery for Crohn's disease: implications for early treatment strategies.

OBJECTIVES: In this study we aimed to define the rate of early surgery for Crohn's disease and to identify risk factors associated with early surgery as a basis for subsequent studies of early intervention in Crohn's disease. METHODS: We assembled a retrospective cohort of patients with Crohn's disease diagnosed between 1991 and 1997 and followed for at least 3 yr, who were identified in 16 community and referral-based practices in New England. Chart review was performed for each patient. Details of baseline demographic and disease features were recorded. Surgical history including date of surgery, indication, and procedure were also noted. Risk factors for early surgery (defined as major surgery for Crohn's disease within 3 yr of diagnosis, exclusive of major surgery at time of diagnosis) were identified by univariate analysis. Multiple logistic regression was used to identify independent risk factors. RESULTS: Of 345 eligible patients, 69 (20.1%) required surgery within 3 yr of diagnosis, excluding the 14 patients (4.1%) who had major surgery at the time of diagnosis. Overall, the interval between diagnosis and surgery was short; one half of all patients who required surgery underwent operation within 6 months of diagnosis. Risk factors identified by univariate analysis as significantly associated with early surgery included the following: smoking; disease of small bowel without colonic involvement; nausea and vomiting or abdominal pain on presentation; neutrophil count; and steroid use in the first 6 months. Disease localized to the colon only, blood in the stool, use of 5-aminosalicylate, and lymphocyte count were inversely associated with risk of early surgery. Logistic regression confirmed independent associations with smoking as a positive risk factor and involvement of colon without small bowel as a negative risk factor for early surgery. CONCLUSIONS: The rate of surgery is high in the first 3 yr after diagnosis of Crohn's disease, particularly in the first 6 months. These results suggest that improved risk stratification and potent therapies with rapid onset of action are needed to modify the natural history of Crohn's disease.

Adolescent↗
PubMed2002

The Stretta procedure for the treatment of GERD: 6 and 12 month follow-up of the U.S. open label trial.

BACKGROUND: This multicenter prospective study investigated the longer-term (12 month) safety and efficacy of radiofrequency energy delivery for the treatment of GERD. METHODS: A prospective study was conducted of 118 patients with chronic heartburn and/or regurgitation who required antisecretory medication daily and had demonstrated pathologic esophageal acid exposure, a sliding hiatal hernia (<or=2 cm), and esophagitis (<or= grade 2). RF energy was delivered with the Stretta catheter and thermocouple-controlled generator to create thermal lesions below the mucosa at the gastroesophageal junction. GERD symptom scores, quality of life (SF-36), and medication use were assessed at 0, 1, 4, 6, and 12 months; esophageal acid exposure, motility, and endoscopy were assessed at 0 and 6 months. RESULTS: Seventy-two men and 46 women were treated. At 12 months, 94 patients were available for follow-up. There were improvements after 12 months in the median heartburn score (4 to 1, p = 0.0001), GERD score (27 to 9, p = 0.0001), satisfaction (1 to 4, p = 0.0001), mental SF-36 (46.3 to 55.4, p < 0.0001), and physical SF-36 (40.9 to 53.1, p = 0.0001); proton pump inhibitor requirement fell from 88.1% to 30% of patients. Esophageal acid exposure improved significantly (10.2% to 6.4%, p = 0.0001). There were 10 (8.6%) complications, none of which required therapeutic intervention. CONCLUSION: The Stretta procedure significantly improves GERD symptoms, quality of life, and esophageal acid exposure and eliminates the need for antisecretory medication in the majority of patients at 12 months.

Adult↗