Comparison of colon adenoma detection rates using cap-assisted and Endocuff-assisted colonoscopy: a randomized controlled trial.

Objectives and study aim Colonoscopy prevents colorectal cancer by removing adenomatous polyps, but missed adenomas lead to interval cancers. Different devices have been used to increase adenoma detection rates (ADR). Two such devices of interest are the transparent cap (Olympus) and Endocuff (ARC Medical). Our study aimed to compare differences in ADR between Endocuff-assisted colonoscopy (EAC), cap-assisted colonoscopy (CAC) and standard colonoscopy (SC). Patients and methods A sample size of 126 subjects was calculated to determine an effect size of 30 %. Patients undergoing screening or surveillance colonoscopy between March 2016 and January 2017 were randomized to SC, CAC or EAC groups. Three experienced endoscopists performed all colonoscopies. Patient demographics, procedure indication, Boston Bowel Prep Score (BBPS), withdrawal time, polyp size, location, histopathology, were analyzed. Results There was no difference in ADR (52 %, 40 % and 54 %) in the SC, CAC and EAC groups respectively ( P  = 0.4). Similar findings were also observed for proximal ADR (45 %, 35 %, and 50 %, P  = 0.4) and SSA detection rate (16 %, 14 %, and 23 %, P  = 0.5). EAC detected higher mean ADR per colonoscopy compared to CAC (1.70 vs 0.76, P  = 0.01). However, there was no significant difference in mean ADR per positive colonoscopy (2.08, 1.63, and 2.59, P  = 0.21). Conclusion In a randomized controlled trial comparing AC to CAC and SC, neither device conferred additional benefits in ADR among high detectors. When comparing each device, EAC may be better than CAC at detecting more total adenomas.

Can Baseline Electromyography Predict Response to Biofeedback for Anorectal Disorder? A Long-Term Follow-Up Study.

BACKGROUND: Biofeedback has been recommended for the treatment of anorectal disorders, especially constipation and fecal incontinence (FI). The objective of this study was to assess the long-term efficacy of biofeedback and evaluate baseline electromyography (EMG) as a predictor for maintenance of long-term improvement. METHODS: A retrospective chart review was performed on randomly selected patients who underwent biofeedback between the years 1990 and 2000. Clinical characteristics, including EMG values at baseline (resting and contraction) as well as EMG after exercises, were collected. Patients were contacted and were classified as "improved" if they had self-reported symptomatic improvement and "not-improved" if their symptoms were unchanged or worsened. RESULTS: A total of 41 subjects were included. Majority (85.4%) were female, the mean age was 48.95 ± 15.46 (range 22 - 77 years) and the median follow-up was 4 years (range 4 - 5 years). Constipation was the primary indication for biofeedback in 27/41 (65.9%), FI in 9/41 (22%) and "other" in 5/41 (12.1%). Within constipation, 55.6% reported long-term improvement as compared to 66.7% of FI and 80% of the other patients. There was borderline difference in the baseline EMG (3.11 ± 1.85 µV, improved, and 7.41 ± 11.01 µV, not improved, P = 0.06) but no significant difference in post-exercise resting (3.13 ± 3.21 µV, improved, and 4.28 ± 3.63 µV, not improved, P = 0.33) and contraction EMG between the two groups. CONCLUSIONS: Biofeedback is an important treatment tool in anorectal disorders. Over 50% of our subjects maintained their improvement 4 - 5 years after completing biofeedback therapy. A lower resting baseline EMG showed a trend of association with improvement in the long term.

Efficacy of Gastric Electrical Stimulation for Gastroparesis: US/European Comparison.

BACKGROUND: Gastric electrical stimulation (GES) is used in both the US and Europe, but little research has investigated the demographics of gastroparesis patients receiving GES by geographic location. METHODS: We compared data from 380 patients, 296 female and 84 males, mean age 42 years, 246 idiopathic (ID), 107 diabetic (DM), and 27 post-surgical (PS). The statistical significance was calculated by Chi-square test and a P-value obtained for ID, DM, and PS. The statistical significance was calculated by Fischer exact test and a P-value obtained comparing male vs. female. RESULTS: European centers had 61 GES patients compared to 319 from the US. In Europe, 100% of patients had gastric emptying test (GET) values available; in the US, it was 75% of patients. European centers had more DM patients (59%) than the US (22%), and a smaller proportion of ID patients (25%) than the US (72%). There was a statistical difference between the causes of gastroparesis in the patients receiving GES (P-value < 0.00001). There was also significant difference in the gender of the patients receiving GES, with a greater proportion of women in the US (P value = 0.0023). CONCLUSIONS: Comparing GES in US vs. Europe demonstrated significant differences in gastroparesis demographics and percentage of patients with GET data. After analyzing the previously discussed results and reviewing recent updates in evidence-based medicine guidelines, the discrepancy and variance in patient populations in the US and Europe emphasizes the need for a database that allows better analysis and treatment of gastroparesis patients worldwide including stimulation therapies.

Anal Intraepithelial Neoplasia.

Anal squamous cell cancer (SCC) is a relatively uncommon cancer in the United States. Anal SCC has long been associated with human immunodeficiency virus (HIV) positivity and/or men who have sex with men. The incidence of anal SCC has been increasing in both genders regardless of HIV status. Few clinicians are aware that white women, when not controlling for gender and sexual preference together, have the highest incidence of anal SCC. Anal intraepithelial neoplasia (AIN), dysplastic cells of the anal canal due to human papilloma virus infection, is believed to be the precursor to anal SCC. A vaccination has been approved by the Federal Drug Administration (FDA) for the prevention of high-risk human papilloma virus infections in presexually active girls and boys. Currently, there are no consensus guidelines for AIN screening, treatment or follow-up. Although anal SCC is treatable when caught early, treatment is often associated with significant morbidity. The purpose of this paper is to raise awareness of anal SCC and its precursor, AIN, in the non-HIV+ and non-MSM populations, and discuss means by which to decrease the incidence of anal SCC in all populations.

Comparisons of screening colonoscopy performed by a nurse practitioner and gastroenterologists: a single-center randomized controlled trial.

Several barriers to colorectal cancer screening have been identified including limited access to trained endoscopists and highlight insufficient capacity to meet projected demand for colonoscopies. Two European studies have found that nonphysician providers can perform colonoscopies as safely and accurately as physicians. Training nurse practitioners (NP) to perform colonoscopy may be an effective strategy to increase access. The goal of this study was to compare accuracy, safety, and patient satisfaction in screening colonoscopy performed by board certified gastroenterologists (GI-MD) and a gastroenterology trained nurse practitioner (GI-NP). A consecutive sample of average risk participants referred for screening colonoscopy was randomized to have their procedure performed by either a GI-MD (n = 100) or a GI-NP (n = 50). Participants completed a preprocedure and postprocedure questionnaire. Endoscopists completed a postprocedure questionnaire. Cecal intubation rates, duration of procedure, sedative, and analgesic use, and patient reported procedural pain scores were equivalent among the groups. The GI-NP group had a higher adenoma detection rate compared with the combined GI-MD groups (42% and 17%, respectively, p = .0001) and a higher satisfaction score when compared with the combined GI-MD groups (mean 5.9 ± 13.81 and 8.6 ± 16.11, respectively, p = .042; visual analog scale 0-100 mm, "0" = completely satisfied, "100" = completely dissatisfied). There were no immediate complications reported in any group. The properly trained GI-NP in our study performed screening colonoscopy as safely, accurately, and satisfactorily as the GI-MDs. Using well-trained NPs for screening colonoscopy can be an effective strategy to increase access to colorectal screening.

Gastric electrical stimulation is safe and effective: a long-term study in patients with drug-refractory gastroparesis in three regional centers.

BACKGROUND: Drug-refractory gastroparesis has previously been without acceptable alternative therapies. Although gastric electrical stimulation has been used for over a decade, no long-term multicenter data exist. METHODS: We studied 214 consecutive drug-refractory patients with the symptoms of gastroparesis (146 idiopathic, 45 diabetic, 23 after surgery) who consented to participate in a variety of clinical research and clinical protocols at three centers from January 1992 through January 2005, resulting in 156 patients implanted with a gastric electrical stimulation device and the other 58 patients serving as controls. The patients were stratified into three groups: (1) consented but never permanently implanted; (2) implanted with permanent device, and (3) consented while awaiting a permanent device. The patients were followed over time for gastrointestinal symptoms, solid gastric emptying, health-related quality of life, survival, device retention, and complications. Demographics, descriptive statistics, and t tests were used for comparison between baseline and latest follow-up. RESULTS: At latest follow-up, median 4 years for 5,568 patient months, most patients implanted (135 of 156) were alive with intact devices, significantly reduced gastrointestinal symptoms, and improved health-related quality of life, with evidence of improved gastric emptying, and 90% of the patients had a response in at least 1 of 3 main symptoms. Most patients explanted, usually for pocket infections, were later reimplanted successfully. There were no deaths directly related to the device. CONCLUSION: Based on this sample of patients, implanted with gastric electrical stimulation devices at three centers and followed for up toward a decade, gastric electrical stimulation for drug-refractory gastroparesis is both safe and effective.

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) 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.

Laparoscopy shortens length of stay in patients with gastric electrical stimulators.

BACKGROUND: Gastric electrical stimulation has been proven effective for drug-refractory gastroparesis. Placement of stimulator leads and device usually requires a laparotomy, although laparoscopic placement has also been used. METHODS: To compare laparotomy with laparoscopy, we examined 36 patients, 18 undergoing laparoscopy and 18 undergoing laparotomy, matched for primary diagnosis and health resource usage. We compared baseline symptoms, length of surgery, length of postoperative hospital stay, gastric emptying, and health resources in each of the 2 groups over time, to see what variables, if any, differed. RESULTS: Baseline symptoms, gastric emptying, and health resource usage were similar. Operative times were also similar, but length of stay declined from a mean of 6.4 days for laparotomy to 1.1 days for laparoscopy. Long-term outcome, via symptoms, gastric emptying, and health resource utilization were comparable between the 2 groups. CONCLUSION: Laparoscopic placement of gastric electrical stimulator leads and device is associated with shorter lengths of postoperative hospital stay. However, the patients who underwent laparotomy had higher vomiting scores and more previous abdominal surgeries at baseline, and higher long-term mortality at follow-up, suggesting that they may be more ill, as a group, than the laparoscopic patients. Laparoscopic placement of devices may be preferable when technically feasible.

Temporary gastric electrical stimulation with orally or PEG-placed electrodes in patients with drug refractory gastroparesis.

BACKGROUND: Gastric electrical stimulation (GES) has been shown to be efficacious for drug refractory gastroparesis, but GES requires surgery. Placement of temporary GES electrodes endoscopically (ENDOstim) or via a PEG (PEGstim) is feasible, thereby allowing rapid assessment and comparison of temporary use (TEMP) with permanent (PERM) implantation. METHODS: Twenty consecutive patients with gastroparesis had TEMP electrodes placed (6 ENDOstim, 14 PEGstim). TEMP alone and TEMP vs. PERM placement of GES devices in 13 of 20 patients were compared via the following: average vomiting frequency score (VFS), total symptom score, days to symptom improvement, electrode impedance, and gastric emptying test. RESULTS: For patients receiving TEMP, GES demonstrated a rapid, significant, and sustained improvement in VFS, results similar to those for PERM. CONCLUSIONS: Both ENDO and PEG placement of GES electrodes are safe and effective in patients with gastroparesis, with outcomes that correspond to those achieved with permanent GES implantation.

Gastric electrical stimulation is associated with improvement in pancreatic exocrine function in humans.

OBJECTIVE: To define the possible effects of gastric electrical stimulation (GES) for gastroparesis on pancreatic function, we performed 2 related human studies. METHODS: Fecal elastase values were compared in 2 patient groups: (1) GES devices ON and (2) GES devices OFF and (2) in 3 control groups: (1) no response (NR) to prokinetic medications, (2) positive response (RES) to medications, and (3) normal controls. Polypeptide levels in 7 of 9 GES patients with device ON and OFF, elastase results, GI symptoms (TSS), and heart rate variability (HRV) were compared by paired t tests and/or ANOVA and reported as mean +/- SE. RESULTS: Elastase was different for GES-ON and OFF (508.0 +/- 92.2 vs. GES-OFF 378.6 +/- 87.4, P < 0.05). Elastase was lower in medication NR and RES than in normal controls. Postprandial pancreatic polypeptide was greater with GES ON than OFF (P = 0.07). HRV revealed a lower percentage of change with device ON versus OFF (44.2 +/- 5.5 vs. 48.5 +/- 5.2, P = 0.08) and lower TSS with ON versus OFF (15.9 +/- 4.5 vs. 25.7 +/- 5.3, P < 0.05). CONCLUSIONS: GES improves exocrine pancreatic release, effects autonomic control, and improves GI symptoms, suggesting a possible role for GES in the treatment of pancreatic insufficiency associated with gastroparesis.

Gastric electrical stimulation for gastroparesis improves nutritional parameters at short, intermediate, and long-term follow-up.

BACKGROUND: Nutritional depletion, either macronutrient- or micronutrient-related, is common in patients with drug-refractory gastroparesis (GP) for which there is often no effective treatment. We studied a group of 12 patients (4 men, 8 women; mean age, 35.7 years) who had symptoms of GP and were a subset of the Gastric ElectroMechanical Stimulation trial of gastric electrical stimulation. Patients' symptoms were of long duration (7.3 years) and associated with diabetes mellitus (3 patients) or were idiopathic (9 patients) as etiology. METHODS: The patients had permanent gastric electrical stimulation devices surgically implanted after a positive trial of temporary stimulation. Patients had baseline measures of gastrointestinal total symptom score (TSS), laboratory (albumin and related) measures, weight (kg), body mass index, and route of nutrition: oral feeding, enteral tubes, or hyperalimentation, repeated at 3, 6, and 12 months. Intermediate-term follow-up was done at 1 to 2 years, and long-term follow-up was done at 5 years and included gastrointestinal TSS, weekly vomiting frequency score, and nutrition and overall health-related quality-of-life measures. RESULTS: Gastric electrical stimulation was associated with rapid improvement over the short-term in TSS (35.6 at baseline to 16.6 at month 12; p < .05), body weight, body mass index, and serum albumin over the short term with most parameters improving by 3 to 6 months. Intermediate (1 to 2 years) and long-term (5 year) data showed continued improvement in TSS, vomiting frequency (weekly vomiting frequency score 3.9 at baseline to 1.7 at 5 years; p < .01), quality-of-life measures, and maintenance of weight gain. CONCLUSIONS: Gastric electrical stimulation implantation resulted in improvement of nutritional parameters throughout the first 12 months, as nausea and vomiting decreased and oral intake increased. This improvement in nutritional measures is maintained long-term and is associated with improvements in quality of life. Gastric electrical stimulation should be considered as a therapeutic option for any patients with refractory GP and nutritional compromise.