Randomized Controlled Trial of Over-the-Scope Clip as Initial Treatment of Severe Nonvariceal Upper Gastrointestinal Bleeding.

BACKGROUND AND AIMS: No prior randomized controlled trial (RCT) has reported patient outcomes of large over-the-scope clip (OTSC) compared to standard hemostasis as initial endoscopic treatment of severe NVUGIB. This was our study aim. METHODS: Patients with bleeding ulcers or Dieulafoy's lesions and major stigmata of hemorrhage - SRH (active spurting bleeding, visible vessel, or clot) - or lesser SRH (oozing bleeding or flat spots - with arterial blood flow by Doppler probe) were randomized to OTSC or standard endoscopic hemostasis (with hemoclips or multipolar electrocoagulation - MPEC). Patients and their healthcare providers were blinded to treatments and made all post-randomization management decisions. Ulcer patients received high dose intravenous infusions of proton pump inhibitors (PPI) for 3 days, then 27 days of oral PPI. 30 day outcomes were prospectively recorded; data management was with SAS; and data analysis was by a statistician. RESULTS: 53 patients (25 OTSC, 28 Standard) were randomized, with similar baseline risk factors. However, there were significant differences in OTSC vs. Standard groups in rates of rebleeding (4% vs. 28.6%; p = .017; relative risk 0.10, 95% confidence intervals 0.01, 0.91; number needed to treat 4); severe complications (0 % vs. 14.3%); and post-randomization units of red cell transfusions (0.04 vs. 0.68). All rebleeds occurred in patients with major SRH and none with lesser SRH. CONCLUSION: 1. OTSC significantly reduced rates of rebleeding, severe complications, and post-randomization red cell transfusions. 2. Patients with major stigmata benefited significantly from hemostasis with OTSC, but those with lesser stigmata did not. (ClinicalTrials.gov, Number: NCT03065465).

A Case of Asymptomatic Syphilitic Proctitis.

The incidence of syphilis is increasing. Syphilitic proctitis involving the rectal mucosa often presents with pain on defecation, rectal bleeding, or ulceration. We present a case of asymptomatic syphilitic proctitis diagnosed upon a routine screening colonoscopy.

Increased risk for irritable bowel syndrome after acute diverticulitis.

BACKGROUND & AIMS: Individuals with diverticulosis frequently also have irritable bowel syndrome (IBS), but there are no longitudinal data to associate acute diverticulitis with subsequent IBS, functional bowel disorders, or related emotional distress. In patients with postinfectious IBS, gastrointestinal disorders cause long-term symptoms, so we investigated whether diverticulitis might lead to IBS. We compared the incidence of IBS and functional bowel and related affective disorders among patients with diverticulitis. METHODS: We performed a retrospective study of patients followed up for an average of 6.3 years at a Veteran's Administration medical center. Patients with diverticulitis were identified based on International Classification of Diseases, 9th revision codes, selected for the analysis based on chart review (cases, n = 1102), and matched with patients without diverticulosis (controls, n = 1102). We excluded patients with prior IBS, functional bowel, or mood disorders. We then identified patients who were diagnosed with IBS or functional bowel disorders after the diverticulitis attack, and controls who developed these disorders during the study period. We also collected information on mood disorders, analyzed survival times, and calculated adjusted hazard ratios. RESULTS: Cases were 4.7-fold more likely to be diagnosed later with IBS (95% confidence interval [CI], 1.6-14.0; P = .006), 2.4-fold more likely to be diagnosed later with a functional bowel disorder (95% CI, 1.6-3.6; P < .001), and 2.2-fold more likely to develop a mood disorder (CI, 1.4-3.5; P < .001) than controls. CONCLUSIONS: Patients with diverticulitis could be at risk for later development of IBS and functional bowel disorders. We propose calling this disorder postdiverticulitis IBS. Diverticulitis appears to predispose patients to long-term gastrointestinal and emotional symptoms after resolution of inflammation; in this way, postdiverticulitis IBS is similar to postinfectious IBS.

Long-term risk of acute diverticulitis among patients with incidental diverticulosis found during colonoscopy.

BACKGROUND & AIMS: Colonic diverticulosis is the most common finding during routine colonoscopy, and patients often question the significance of these lesions. Guidelines state that these patients have a 10% to 25% lifetime risk of developing acute diverticulitis. However, this value was determined based on limited data, collected before population-based colonoscopy, so the true number of cases of diverticulosis was not known. We measured the long-term risk of acute diverticulitis among patients with confirmed diverticulosis discovered incidentally on colonoscopy. METHODS: We performed a retrospective study using administrative and clinical data from the Veterans Affairs Greater Los Angeles Healthcare System, collecting data on patients who underwent colonoscopies from January 1996 through January 2011. We identified patients diagnosed with diverticulosis, determined incidence rates per 1000 patient-years, and analyzed a subgroup of patients with rigorously defined events confirmed by imaging or surgery. We used a Cox proportional hazards model to identify factors associated with the development of diverticulitis. RESULTS: We identified 2222 patients with baseline diverticulosis. Over an 11-year follow-up period, 95 patients developed diverticulitis (4.3%; 6 per 1000 patient-years); of these, 23 met the rigorous definition of diverticulitis (1%; 1.5 per 1000 patient-years). The median time-to-event was 7.1 years. Each additional decade of age at time of diagnosis reduced the risk for diverticulitis by 24% (hazard ratio, 0.76; 95% confidence interval, 0.6-0.9). CONCLUSIONS: Based on a study of the Veterans Affairs Greater Los Angeles Healthcare System, only about 4% of patients with diverticulosis develop acute diverticulitis, contradicting the common belief that diverticulosis has a high rate of progression. We also found that younger patients have a higher risk of diverticulitis, with risk increasing per year of life. These results can help inform patients with diverticulosis about their risk of developing acute diverticulitis.

Development and validation of a novel patient educational booklet to enhance colonoscopy preparation.

OBJECTIVES: The success of colonoscopy depends on high-quality bowel preparation by patients; yet inadequate preparation is common. We developed and tested an educational booklet to improve bowel preparation quality. METHODS: We conducted patient cognitive interviews to identify knowledge and belief barriers to colonoscopy preparation. We used these interviews to create an educational booklet to enhance preparatory behaviors. We then prospectively randomized patients scheduled for outpatient colonoscopy at a VA Medical Center to receive usual instructions vs. the booklet before colonoscopy. Patients in both groups received standard pharmacy instructions for single-dose bowel preparation; the protocol did not specify which purgatives to prescribe. The primary outcome was preparation quality based on blinded ratings using the validated Ottawa score. We performed bivariate analyses to compare mean scores between groups using a t-test, and logistic regression to measure the booklet effect on preparation quality, adjusting for potential confounders. RESULTS: A total of 436 patients were randomized between arms. In an intention-to-treat analysis of the primary outcome, mean Ottawa scores were superior in patients allocated to booklet vs. controls (P=0.03). An intention-to-treat analysis of the secondary outcome revealed a "good" preparation in 68 vs. 46% of booklet and control patients, respectively (P=0.054). In a per-protocol analysis limited to patients who actually received the booklet, preparation was good in 76 vs. 46% patients, respectively (P<0.00001). Regression analysis revealed that booklet receipt increased the odds of good preparation by 3.7 times (95% confidence interval=2.3-5.8). CONCLUSIONS: Provision of a novel educational booklet considerably improves preparation quality in patients receiving single-dose purgatives. The effect of the booklet on split-dose purgatives remains untested and will be evaluated in future research.

Colonoscopy yields fewer polyps as the day progresses despite using social influence theory to reverse the trend.

BACKGROUND: We previously reported that fewer polyps are detected by colonoscopy as the day progresses, a phenomenon that could be modified with "social influence theory" by using auditing and feedback. OBJECTIVE: To measure the impact of a social influence informational poster on the relationship between time of day and colonoscopy yield. DESIGN: Controlled before-and-after study comparing the polyp yield and time of day relationship in a historical cohort versus a 3-month intervention period. SETTING: University-based Veterans Affairs medical center. PATIENTS: Patients undergoing outpatient screening, surveillance, or diagnostic colonoscopies. INTERVENTION: Placement of informational posters in endoscopy rooms within view of operators and nurses. The poster depicted a bar graph of the previously documented hour-by-hour decreases in polyp yield coupled with prominent text: "What Time Is It Now?" MAIN OUTCOME MEASUREMENT: Polyp yield, including secondary end point limited to adenoma detection. We performed regression to measure the effect of start time on polyp yield. RESULTS: There were 477 and 301 patients in the control and intervention periods, respectively. There was a negative relationship between start time and polyp yield, including adenoma detection, for both periods (P = .001). Start time remained negatively predictive of polyp and adenoma yield after adjusting for poster exposure and confounders (P = .01). LIMITATIONS: Nonrandomized study design. CONCLUSION: An informational poster did not alter the relationship between colonoscopy start time and polyp yield. This strengthens the previous finding that start time may affect polyp yield and suggests that passive use of social influence theory is inadequate to modify this effect. Shortening endoscopy shifts and active auditing with feedback may be necessary.

Evaluation and treatment of iron deficiency anemia: a gastroenterological perspective.

A substantial volume of the consultations requested of gastroenterologists are directed towards the evaluation of anemia. Since iron deficiency anemia often arises from bleeding gastrointestinal lesions, many of which are malignant, establishment of a firm diagnosis usually obligates an endoscopic evaluation. Although the laboratory tests used to make the diagnosis have not changed in many decades, their interpretation has, and this is possibly due to the availability of extensive testing in key populations. We provide data supporting the use of the serum ferritin as the sole useful measure of iron stores, setting the lower limit at 100 microg/l for some populations in order to increase the sensitivity of the test. Trends of the commonly obtained red cell indices, mean corpuscular volume, and the red cell distribution width can provide valuable diagnostic information. Once the diagnosis is established, upper and lower gastrointestinal endoscopy is usually indicated. Nevertheless, in many cases a gastrointestinal source is not found after routine evaluation. Additional studies, including repeat upper and lower endoscopy and often investigation of the small intestine may thus be required. Although oral iron is inexpensive and usually effective, there are many gastrointestinal conditions that warrant treatment of iron deficiency with intravenous iron.

Surfing as a risk factor for gastroesophageal reflux disease.

OBJECTIVE: To compare the prevalence of gastroesophageal reflux disease (GERD) in surfers versus nonsurfers who participate in other sports activities based on the hypothesis that paddling in the prone position on hard surfboard surfaces leads to increased intra-abdominal pressure and GERD. STUDY DESIGN: A questionnaire survey using a modified Gastrointestinal Symptom Rating Scale. SETTING: Data obtained from surfers and nonsurfer athletes on the island of Oahu in the state of Hawaii. PARTICIPANTS: One hundred eighty-five surfers and 178 nonsurfers who participate in sports activities. ASSESSMENT OF RISK FACTORS: Surfer or nonsurfer status, type of surfboard used, frequency of surfing, and duration of surfing experience. MAIN OUTCOME MEASURES: The prevalence of reflux symptoms at least twice a week (GERD). RESULTS: The prevalence of GERD was significantly higher in short-board surfers than in nonsurfers with an odds ratio of 4.6 (28% versus 7%, P < 0.001) after adjustment for demographic variables using the multivariate regression model. GERD was more prevalent in short-boarders than long-boarders (28% and 12%, respectively). The prevalence of GERD increased significantly as both the frequency and duration of surfing experience increased (P < 0.001). CONCLUSION: Surfing is strongly associated with GERD. Short-board surfing appears to have a stronger association with GERD than long-board surfing.

Severe Ileocolonic Crohn's Disease Flare Associated with Fecal Microbiota Transplantation Requiring Diverting Ileostomy.

Patients with inflammatory bowel disease (IBD) are at increased risk of developing Clostridium difficile infection (CDI). Fecal microbiota transplantation (FMT) is an effective therapy with a high success rate in preventing recurrent CDI. However, patients with IBD have decreased response to FMT for recurrent CDI, with several reports also suggesting potential IBD flare post-FMT. We present a case of mild ileocolonic Crohn's disease in a patient treated with FMT for recurrent CDI who subsequently developed severe steroid-refractory flare requiring surgical intervention 1 week post-FMT. Greater understanding of risk factors associated with post-FMT IBD flare is indicated.

Postoperative Gastrointestinal Telemetry with an Acoustic Biosensor Predicts Ileus vs. Uneventful GI Recovery.

BACKGROUND: Postoperative ileus (POI) can worsen outcomes, increase cost, and prolong hospitalization. We previously found that a disposable, non-invasive acoustic gastrointestinal surveillance (AGIS) biosensor distinguishes healthy controls from patients recovering from abdominal surgery. Here, we tested whether AGIS can prospectively predict which patients will develop POI in a multicenter study. STUDY DESIGN: AGIS is a disposable device embedded with a microphone that adheres to the abdominal wall and connects to a computer that measures acoustic intestinal rate (IR), defined as motility events/minute. We applied AGIS for 60 min before and continuously after abdominal surgery. Clinicians blinded to AGIS recordings clinically separated patients into those with vs. without POI. We used receiver operating characteristic curve analysis to calculate sensitivity, specificity, and negative predictive value (NPV) of AGIS to predict POI. RESULTS: There were 28 subjects; nine developed POI. Median IR was 3.01/min and 4.46/min between POI and non-POI groups, respectively (P = 0.03). AGIS predicted POI onset with a sensitivity, specificity, and NPV of 63, 72, and 81%, respectively. CONCLUSION: Non-invasive, abdominal, acoustic monitoring prospectively predicts POI. Surgeons may use AGIS to rule out POI with over 80% certainty; this offers added confidence to advance feeding earlier in those for whom it is safe.

Validation of an acoustic gastrointestinal surveillance biosensor for postoperative ileus.

BACKGROUND: Postoperative ileus (POI) can worsen outcomes, increase cost, and prolong hospitalization. An objective marker could help identify POI patients who should not be prematurely fed. We developed a disposable, non-invasive acoustic gastro-intestinal surveillance (AGIS) biosensor. We tested whether AGIS can distinguish healthy controls from patients recovering from abdominal surgery. STUDY DESIGN: AGIS is a disposable plastic device embedded with a microphone that adheres to the abdominal wall and connects to a computer that measures acoustic event rates. We compared intestinal rates of healthy subjects using AGIS for 60 min after a standardized meal to recordings of two postoperative groups: (1) patients tolerating standardized feeding and (2) POI patients. We compared intestinal rates among groups using ANOVA and t tests. RESULTS: There were 8 healthy controls, 7 patients tolerating feeding, and 25 with POI; mean intestinal rates were 0.14, 0.03, and 0.016 events per second, respectively (ANOVA p < 0.001). AGIS separated patients from controls with 100 % sensitivity and 97 % specificity. Among patients, rates were higher in fed versus POI subjects (p = 0.017). CONCLUSION: Non-invasive, abdominal acoustic monitoring distinguishes POI from non-POI subjects. Future research will test whether AGIS can identify patients at risk for development of POI and assist with postoperative feeding decisions.

Are immunosuppressive medications associated with decreased responses to routine immunizations? A systematic review.

BACKGROUND: Long-term immunosuppressive medications are being used more commonly for a variety of medical conditions, including immune-mediated diseases and organ transplantation. While these medications are often necessary, they are associated with an increased risk of serious infections. Vaccination may be a way to prevent a variety of infections but vaccine responses among patients receiving immunosuppressive therapies have been variable. PURPOSE: To systematically review the literature describing immune responses among patients on immunosuppressive therapies to vaccinations including influenza, pneumococcal, meningococcal, hepatitis A and B, tetanus toxoid, pertussis, varicella, and zoster. DATA SOURCES: English language citations in the MEDLINE and EMBASE databases from 1985 to 2010. STUDY SELECTION: Two reviewers independently screened titles and abstracts to identify prospective, controlled studies reporting pre- and post-vaccination titers of recommended vaccines in patients receiving long-term immunosuppressive therapies for full-text review. DATA EXTRACTION: Three reviewers independently assessed study characteristics including treatment regimens and pre- and post-vaccination titers. DATA SYNTHESIS: Of the 972 identified titles, fifteen met inclusion criteria. Ten studies assessed the effects of immunosuppressive medications on responses to influenza vaccine, four studies investigated responses following pneumococcal vaccination, and one study assessed both influenza and pneumococcal vaccination. Five of the studies that evaluated influenza vaccination showed partially diminished responses among individuals receiving immunosuppressive therapies, while one of the pneumococcal vaccine studies showed significantly decreased responses following vaccination. Patients treated with more than one immunosuppressive medication were the least likely to respond to vaccination. LIMITATIONS: The heterogeneity of reported outcomes limits generalizeability. CONCLUSIONS: Immunosuppressive therapy, particularly combination regimens, may blunt response to influenza and pneumococcal vaccinations. To ensure the best chance of response, immunizations should be administered prior to initiation of immunosuppressive medications whenever possible.