Variable stiffness colonoscopes are associated with less pain during colonoscopy in unsedated patients

OBJECTIVES: Application of a new variable stiffness colonoscope (VSC) is expected to control loop formation and to lessen patient discomfort. The aim of this prospective study was to compare the efficacy of VSC with a conventional colonoscope (CC) in unsedated colonoscopy, based on the experience of examiners. METHODS: Four-hundred sixty-seven patients were randomly assigned to undergo colonoscopy with either VSC or CC by an endoscopist, including experienced and less-experienced examiners. The percentages of completed procedure and time to cecal intubation were recorded. Patients were asked to rate pain on a 5-point pain score. RESULTS: The percentages of completed procedure with VSC and CC were 98% and 95%, respectively, by less-experienced hands, and 99% and 98%, respectively, by experienced hands. Time for cecal intubation with VSC and CC was 15.7 and 18.5 min, respectively, by less-experienced hands, and 9.8 and 10.6 min, respectively, by experienced hands. A significantly lower mean pain score was noted in VSC patients compared with CC patients, irrespective of experience of the examiner. The percent of patients rating the procedure as moderately or severely painful was significantly lower with VSC than with CC, both in less-experienced (19% vs 40%; p < 0.01) and experienced hands (15% vs 26%; p < 0.05). CONCLUSIONS: Our results indicated that VSC allows favorable examination compared with CC regarding completeness, time to cecal intubation, and comfort of patients undergoing unsedated colonoscopy, irrespective of the examiner's experience. These features suggest VSC as the preferred colonoscope for patients undergoing unsedated colonoscopy.     

A prospective trial of variable stiffness pediatric vs. standard instrument colonoscopy

BACKGROUND: The pediatric variable stiffness colonoscope is believed to have theoretical advantages over the standard colonoscope, however a systematic evaluation of this instrument in routine clinical practice involving adult patients is lacking. METHODS: Consecutive patients (blinded) undergoing colonoscopy in an outpatient endoscopy center by one of 4 experienced colonoscopists had the procedure performed with a standard colonoscope (n=384) or pediatric variable stiffness colonoscope (n=413). Failure to negotiate the sigmoid colon within 10 minutes was regarded as a failure and, if suitable, the patient was crossed over to colonoscopy with the alternative instrument. RESULTS: Median (95% CI) time to the cecum was significantly faster in the pediatric variable stiffness colonoscope group (odds ratio 5.0: 95% CI[4.7,5.3] minutes) compared with the standard colonoscope group (odds ratio 5.5: 95% CI[5.2,5.8] minutes, p=0.01). There were 22 failures overall (2.8%), 14 in the standard colonoscope group (3.6%) and 8 in the pediatric variable stiffness colonoscope group (1.9%; p=0.1). With regard to the 14 failures in the standard colonoscope group, colonoscopy was attempted with the pediatric variable stiffness colonoscope in 13 and completed successfully in 12 (92%). The pediatric variable stiffness colonoscope was superior in cases of severe stenosing diverticular disease; two of 27 examinations with the pediatric variable stiffness colonoscope were rated as failed vs. 12 of 18 with the standard colonoscope (p<0.001). CONCLUSIONS: Intubation time was faster with the pediatric variable stiffness colonoscope, but use of this instrument was not associated with a superior cecal intubation rate compared with the standard colonoscope. However, in patients with severe stenosing diverticular disease, the intubation rate with the pediatric variable stiffness colonoscope was superior.     

One- or two-operator techniques for oesophago-gastro-duodenoscopy in unsedated patients: A comparative prospective randomized study

BackgroundThe standard oesophago-gastro-duodenoscopy procedure is performed with a single endoscopist (SE). Nurse-assisted (NA) oesophago-gastro-duodenoscopies have not yet been studied. We aimed to evaluate the efficacy of an NA endoscopy compared to an SE endoscopy.MethodsA prospective, single-center, randomized trial, in which 500 adult patients were divided into two groups. In the first group, patients underwent an endoscopy with an SE. In the second group, the endoscopy was performed with an NA. The ease of the procedure (scores 1–4; 1 difficult, 2 satisfactory, 3 easy, 4 very easy), evaluation of patient satisfaction (scores 1–4; 1 uncomfortable, 2 satisfactory, 3 comfortable, 4 very comfortable), total time of the procedure and vocal cord observation were determined as quality indicators.ResultsMean patient satisfaction scores in groups 1 and 2 were 2.98 ± 0.79 and 3.11 ± 0.78, respectively (p = 0.043), with uncomfortable ratings in 5.2% vs 4%, satisfactory in 16.8% vs 13.2%, comfortable in 53.2% vs 50.4%, and very comfortable in 24.8% vs 32.4% of patients in groups 1 and 2, respectively. Retching rates during the procedure were 54.4% and 45.2% (p = 0.040) in groups 1 and 2, respectively. No differences were seen in vocal cord observation (54.4% vs 56.0%), total procedure time (2.35 ± 1.56 vs 2.41 ± 1.48 min) and easy score (3.26 ± 0.603 vs 3.25 ± 0.64) in groups 1 and 2 for the procedures. Very easy, easy, satisfactory, and difficult ratings were given by 33.6% vs 34.8%, 60.4% vs 56.4%, 4.8% vs 7.6% and 1.2% vs 1.2% of groups 1 and 2, respectively.ConclusionsCompared with the conventional method, the assisted endoscopic technique provides more comfort and less gag reflex without increasing the processing time or difficulty of performing the procedure.     

A new variable stiffness colonoscope makes colonoscopy easier: a randomised controlled trial

BACKGROUND: Colonoscopy remains technically difficult in 10-20% of procedures due to variable colonic anatomy and fixation. The ability to vary endoscope shaft flexibility may help insertion to the caecum. METHODS: Consecutive patients attending for day case colonoscopy were randomised to examination with either the conventional Olympus CF200HL (200HL) or a new variable stiffness (VS) colonoscope. Intubation time, use of stiffening function, and patient pain scores were compared. RESULTS: Of 100 cases, 43 were performed with the 200HL and 57 with the VS. Four incomplete examinations occurred with the 200HL (two sigmoid fixations, two benign strictures) and two with the VS (one obstructing cancer, one fixed sigmoid). Changing to the paediatric scope was successful in all but one patient from each group (obstructive lesions). Stiff mode was applied 23 times in 18 patients and was effective in 15 of these. Intubation time was quicker with the VS (median 6 minutes 32 seconds) than with the 200HL (median 10 minutes 35 seconds) (p = 0.0005). Pain scores were less with the VS (median 7) than with the 200HL (median 24) (p = 0.0081). CONCLUSIONS: The variable stiffness colonoscope combines paediatric shaft characteristics with the ability to stiffen when needed. This instrument significantly reduces intubation time and patient discomfort. Further comparisons should be made with the newest colonoscopes which are less stiff.     

A prospective trial of young red cells in 48 patients with transfusion-dependent thalassaemia

Young red cells (YRBC) prepared on a cell washer were compared to whole blood in a randomized prospective trial in 48 transfusion dependent patients with thalassaemia major. A minor but statistically significant decrease in blood consumption was observed in the group receiving YRBC. However, no difference was seen in transfusion interval, mean haemoglobin and rate of haemoglobin fall between the two groups. Filtered blood was shown to be as effective as frozen blood in eliminating non-haemolytic febrile transfusion reactions in all the trial patients. We conclude that any reduction in the rate of iron loading brought about by the use of YRBC is clinically insignificant and does not justify the expense, time and work required to produce young red cells for use in a large transfusion dependent thalassaemic population.     

Prospective randomized trial of transnasal versus peroral endoscopy using an ultrathin videoendoscope in unsedated patients

AIM: The aim of this study was to compare the acceptance and tolerance of transnasal and peroral esophagogastroduodenoscopy (EGD) using an ultrathin videoendoscope in unsedated patients. METHODS: A total of 124 patients referred for diagnostic endoscopy were assigned randomly to have an unsedated transnasal EGD (n = 64) or peroral EGD (n = 60) with local anesthesia. An ultrathin videoendoscope with a diameter of 5.9 mm was used in this study. A questionnaire for tolerance was completed by the patient (a validated 0-10 scale where '0' represents no discomfort/well tolerated and '10' represents severe discomfort/poorly tolerated). RESULTS: Of the 64 transnasal EGD patients, 60 patients (94%) had a complete examination. Four transnasal EGD examinations failed for anatomical reasons; all four patients were successfully examined when switched to the peroral EGD. All 60 peroral EGD patients had a complete examination. Between the transnasal and peroral groups, there was a statistically significant difference in scores for discomfort during local anesthesia (1.5 +/- 0.2 vs 2.6 +/- 0.3, P = 0.003), discomfort during insertion (2.3 +/- 0.3 vs 4.3 +/- 0.3, P = 0.001), and overall tolerance during procedure (1.6 +/- 0.2 vs 3.8 +/- 0.2, P = 0.001). In all, 95% of transnasal EGD patients and 75% of peroral EGD patients (P = 0.002) were willing to undergo the same procedure in the future. Four patients in the transnasal EGD group experienced mild epistaxis. CONCLUSION: For unsedated endoscopy using an ultrathin videoendoscope, transnasal EGD is well tolerated and considerably reduces patient discomfort compared with peroral EGD.     

Hemodynamic effects of different ventilatory patterns. A prospective clinical trial

We compared the hemodynamic effects of three different ventilatory patterns including two variations of the I:E ratio (2:1 and 3:1) and a PEEP-pattern with the MAWP being equal in all three patterns. The study was performed on 15 patients without lung or cardiovascular disease who were ventilated after elective abdominal surgery. Each of the patients was subjected to the three different pressure wave curves. The IPPV served as control. Hemodynamic measurements included TEE registration of the LV cross-sectional areas, diameters and wall thickness as well as arterial blood pressure and heart rate. As a result, we found no significant differences in the hemodynamic effects of all three patterns. Compared with IPPV, they showed a reduction of systolic and diastolic blood pressure, LV dimensions and systolic wall stress. Assessed with the end systolic quotient, LV contractility remained constant.     

A prospective randomized trial of tocainide in patients following myocardial infarction

One hundred forty-six patients with recent acute myocardial infarction were grouped at random into those treated with tocainide, an oral analogue of lignocaine, or placebo and followed up for 6 months. In addition to standard investigations, a 24-hour ambulatory taped ECG recording was obtained prior to randomization and thereafter at 2, 8, 16, and 24 hours after discharge. The ECGs were analyzed by means of an automated, computerized reporting system. Forty-two patients had significant ventricular arrhythmias, 10 of whom had effective plasma levels of tocainide compared with 27 patients on placebo (P < 0.005). In the placebo patients with increasing mobilization there was a consistent rise in the number of ventricular ectopic beats per day. There was no such increase in the tocainide patients (p < 0.01). Side effects were few and the incidence of central nervous system side effects was similar in both the tocainide and placebo groups. There was no conclusive evidence of myocardial depression, heart rate and blood pressure being unchanged over the 6-month period. Although ventricular arrhythmias were suppressed, the number of patients in the study was too small to draw conclusions regarding the mortality rate.     

Gender difference in age-related carotid stiffness: A prospective study in Chinese diabetic patients

BackgroundThe reason for the particularly increased cardiovascular morbidity and mortality in diabetic women remains unclear. The purpose of our study was to prospectively investigate sex difference in carotid stiffness in elder Chinese patients with type-2 diabetes mellitus (T2DM).Methods109 T2DM patients (mean age at baseline, 58.5 years; 65.1% women) were included in the current study. Carotid stiffness index (CSI) was measured using an ultrasonic phase-locked echo-tracking system at baseline (CSI1) and at follow-up (CSI2). Biochemical measurements and clinical information were also measured.ResultsMean value of CSI1 and CSI2 were 4.49 ± 1.45 and 7.84 ± 2.37, respectively. CSI1 were similar in both sex (CSI1: 4.49 ± 1.38 vs 4.51 ± 1.59), while CSI2 was higher in women than in men (CSI2: 8.22 ± 2.41 vs 7.13 ± 2.13). After adjusted for other cardiovascular risk factors, the difference in CSI2 between women and men was still significant. Age was the main determinant of CSI1 in both genders. However, correlation between age and CSI2 was only found in women. Women had higher CSI progression (ΔCSI) than men (3.74 ± 2.22 vs 2.62 ± 1.73). Furthermore, being female was an independent risk factor of ΔCSI.ConclusionAge was the most important risk factor of carotid stiffness. Nevertheless, after a 4 year follow-up, the impact of ageing on carotid stiffness progression only existed in T2DM women.     

A prospective feasibility trial of a novel intravascular catheter system with retractable coiled tip guidewire placed in difficult intravascular access (DIVA) patients in the Emergency Department

The primary study objective was to evaluate insertion success rates. Secondary objectives included patient satisfaction, procedure time, complication rates, completion of therapy and dwell time of the novel AccuCath^® 2.25″ Blood Control (BC) Catheter System (FDA approved) placed in difficult-access patients. This was a single-arm feasibility trial evaluating the AccuCath^® 2.25″ BC Catheter System in a convenience sample of DIVA patients defined as at least two failed initial attempts or a history of difficult access plus the inability to directly visualize or palpate a target vein. All enrolled patients were 18 years of age or older. A total of 120 patients were enrolled. These patients had an average of 3.7 and median of 3 prior attempts at vascular access prior to AccuCath placement. Successful access was gained in 100% of the patients, 77% on the first attempt and all within three attempts; 88.5% of patients completed therapy, with the remaining 12.5% experiencing minor complications that required discontinuation of the catheter. The average patient satisfaction score on a 5-point Likert scale was highly positive at 4.6. Preliminary results show that the AccuCath^® 2.25″ BC Catheter System has excellent success rates in gaining vascular access in an extremely difficult patient population. The device did not lead to any significant complications. Patients were also very satisfied with the procedure.     

A prospective, open-label trial of 6-thioguanine in patients with ulcerative or indeterminate colitis

OBJECTIVE: 6-thioguanine (6-TG) has emerged as a promising therapeutic alternative in patients with Crohn's disease intolerant or resistant to azathioprine (AZA) and/or 6-mercaptopurine (6-MP). The aim of the present study was to evaluate the safety and efficacy of 6-TG in patients with ulcerative colitis (UC) or indeterminate colitis (IC) intolerant or resistant to AZA/6-MP. MATERIAL AND METHODS: Twenty patients with an acute flare, steroid-dependent or steroid-refractory disease attending our outpatient department were included in the study. Measurement of 6-TG nucleotide levels was done to check compliance. Complete, partial and non-response were defined by means of the clinical activity index and the daily steroid demand. Secondary outcome parameters included changes in cumulative steroid doses, C-reactive protein (CRP) levels, and an endoscopic score. RESULTS: Out of 20 patients 4 were excluded owing to noncompliance; 2/16 compliant patients (13%) had to be prematurely withdrawn because of adverse events, which ceased upon drug discontinuation. By per-protocol analysis, 5/14 patients (36%) were complete, 6/14 (43%) partial and 3/14 (21%) non-responders. In addition to the reduction of the cumulative steroid dose over 3 months, CRP decreased in the study population and the endoscopic score decreased in treatment responders. CONCLUSIONS: Treatment with 6-TG was effective in patients with UC or IC previously intolerant or resistant to AZA/6-MP. Future work is needed to define a subpopulation of patients at low risk for its potential hepatotoxicity, which we assume will benefit from 6-TG.     

Preoperative immunonutrition in patients undergoing liver resection:A prospective randomized trial

BACKGROUND Preoperative supplementation with immunonutrients, including arginine and n-3 fatty acids, has been shown in a number of systematic reviews to reduce infectious complications in patients who have undergone gastrointestinal surgery. Limited information, however, is available on the benefits of nutritional supplementation enriched with arginine and n-3 fatty acids in patients undergoing liver resection.AIM To evaluate the effects of preoperative nutritional supplementation enriched with arginine and n-3 fatty acids on inflammatory and immunologic markers and clinical outcome in patients undergoing liver resection.METHODS Thirty-four patients undergoing liver resection were randomized to either five days of preoperative Impact? [1020 kcal/d, immunonutrition(IMN) group], or standard care [no supplementation, standard care(STD) group]. Nutritional status was measured at study entry by subjective global assessment(SGA).Functional assessments(grip strength, fatigue and performance status) were carried out at study entry, on the day prior to surgery, and on postoperative day(POD) 7 and 30. Inflammatory and immune markers were measured at study entry, on the day prior to surgery, and POD 1, 3, 5, 7, 10 and 30. Postoperative complications were recorded prospectively until POD30.RESULTS A total of 32 patients(17 IMN and 15 STD) were analysed. All except four patients were SGA class A. The plasma ratio of(eicosapentaenoic acid plus docosahexaenoic acid) to arachidonic acid was higher in IMN patients on the day prior to surgery and POD 1, 3, 5 and 7(P 0.05). Plasma interleukin(IL)-6 concentrations were elevated in the IMN group(P = 0.017 for POD7). No treatment effect was detected for functional measures, immune response(white cell count and total lymphocytes) or markers of inflammation(C-reactive protein,tumour necrosis factor-α, IL-8, IL-10). There were 10 patients with infectious complications in the IMN group and 4 in the STD group(P = 0.087). Median hospital stay was 9(range 4–49) d in the IMN group and 8(3-34) d in the STD group(P = 0.476).CONCLUSION In well-nourished patients undergoing elective liver resection, this study failed to show any benefit of preoperative immunonutrition.