Use of an Abdominal Compression Device in Colonoscopy: A Randomized, Sham-Controlled Trial.

BACKGROUND & AIMS: Looping is a common problem during colonoscopy that prolongs procedure time. We aimed to determine the efficacy and safety of ColoWrap, an external abdominal compression device, with respect to insertion time and other procedural outcomes. METHODS: We performed a prospective study of outpatients undergoing elective colonoscopy (40-80 years old; mean age, 60.5 years) at endoscopy facilities in the University of North Carolina Hospitals from April 2013 through March 2014. Subjects were randomly assigned to groups that received either ColoWrap (n = 175) or a sham device (control, n = 175) during colonoscopy. Colonoscopists and staff were blinded to the application. The primary outcome was cecal intubation time (CIT). Secondary outcomes included use of manual pressure and position change. RESULTS: The mean CIT was similar for the control and ColoWrap groups (6.69 vs 6.67 minutes; P = .98). There were no statistical differences in the frequency of manual pressure (45% for controls vs 37% for ColoWrap group, P = .13) or position changes (4% for controls vs 2% for ColoWrap group, P = .36). Among patients with body mass index between 30 and 40 kg/m(2) (n = 78), CIT was significantly lower for patients in the ColoWrap group (4.69 minutes) than controls (6.10 minutes) (P = .03). Adverse events were similar between groups. CONCLUSIONS: In patients undergoing elective colonoscopy, application of an external abdominal compression device did not improve CIT or affect the frequency of ancillary maneuvers. A possible benefit was observed in patients with body mass index between 30 and 40 kg/m(2), but further studies are needed. ClinicalTrials.gov number: NCT02025504.

Partner burden in irritable bowel syndrome.

BACKGROUND & AIMS: Studies have described the burden experienced by caregivers and next of kin to patients with diseases such as cancer. However, the burden of functional gastrointestinal disorders on partners of patients has not been determined. We aimed to quantify the degree of burden to partners of patients with irritable bowel syndrome (IBS), to describe the factors that affect the burden perceived, and to identify the areas of relationship that are affected. METHODS: We surveyed 152 patients diagnosed with IBS at a tertiary gastrointestinal clinic, on the basis of Rome III criteria, and their partners. Their partners completed questionnaires including the Zarit Burden Interview (ZBI), Relationship Satisfaction Scale, and questions on sexual relationships. Patients with IBS were rated for disease severity by using the Functional Bowel Disease Severity Index. We compared findings with those from 39 partners of healthy individuals (controls). RESULTS: There were no significant demographic differences between the partners of patients with IBS and controls; demographics had no effect on burden. Burden was significantly higher among partners of IBS patients (mean ZBI score, 22.1) than controls (mean ZBI score, 11.5) (P = .0002). The degree of burden was directly related to IBS severity (P < .0001). There were inverse relationships between partners' rating of burden (ZBI) and relationship quality (R = -0.60; P < .001) and sexual satisfaction (R = -0.56; P < .0001). There was no difference in the Relationship Satisfaction Scale scores (4.25 vs 4.19; P = .78) or sexual relationship (6.47 vs 6.21; P = .64) between partners of IBS patients and controls, respectively. CONCLUSIONS: Partners of patients with IBS have a significant burden (on the basis of ZBI score), compared with partners of healthy individuals. Perceived burden increases with IBS severity and poorer sexual and relationship satisfaction.

Diagnosis, characterization, and 3-month outcome after detoxification of 39 patients with narcotic bowel syndrome.

UNLABELLED: OBFECTIVES: Narcotic bowel syndrome (NBS) is characterized by a paradoxical increase in abdominal pain associated with continued or escalating dosages of narcotics. This study evaluated the clinical and psychosocial features of patients with NBS and the response to detoxification treatment. METHODS: For 2 years, 39 patients seen by the GI consult service at the University of North Carolina at Chapel Hill (UNC) with presumed NBS were placed on a detoxification program. Clinical, psychosocial, health status, and outcome data were obtained before and after detoxification. Our aims were to: (i) clinically characterize patients with presumed NBS, (ii) assess the clinical response and adverse effects to detoxification, (iii) identify clinical and psychosocial predictors of treatment response, and (iv) determine the clinical outcome at 3 months after detoxification and the time frame for patients who revert back to narcotics. RESULTS: Of the 39 patients detoxified, 89.7% met predefined criteria. Patients were mostly well educated (14.5 ± 2.3 years of school), female (92.3%), and with a variety of diagnoses (21% irritable bowel syndrome IBS/functional, 37% inflammatory bowel disease and other structural, 29% fibromyalgia and other functional somatic, or orthopedic, and 13% postoperative or other). They reported high health-care use (15.3 ± 10.1 MD visits/6 months; 6.5 ± 6.1 hospitalizations/2 years, 6.4 ± 2.0 surgeries/lifetime), and 82.1% were jobless. Despite high dosages of narcotics (total intravenous (IV) morphine equivalent 75.3 ± 78.0 mg/day), pain scores were rated severe (52.9 ± 28.8 visual analog scale (VAS); 257.1 ± 139.6 functional bowel disorder severity index (FBDSI); 17.2 ± 10.2 (McGill Pain and greater than labor or postoperative pain). Multiple symptoms were reported (n = 17.8 ± 9.2) and rated as moderate to severe. Psychosocial scores showed high catastrophizing (19.9 ± 8.6); poor daily function (Short Form-36 (SF-36) physical 28.3 ± 7.7, mental 34.3 ± 11.0; worse than tetraplegia); 28.2% were clinically depressed and 33.3% anxious (Hospital Anxiety and Depression Scale (HADS)). Detoxification was successfully completed by 89.7%; after detoxification, abdominal pain was reduced by 35% (P < 0.03) and nonabdominal pain by 42% (P < 0.01) on VAS, and catastrophizing significantly improved (P < 0.01). Responder status was met in 56.4% with 48.7% achieving a ≥ 30% reduction in pain. By 3 months after detoxification, 45.8% had returned to using narcotics. For those who remained off narcotics at 3 months, the VAS abdominal pain score was 75% lower than pretreatment when compared with those who went back on narcotics (24% lower). Successful detoxification and a good clinical response was associated with low abuse potential (Current Opioid Misuse Measure (COMM) score < 9). CONCLUSIONS: Despite severe pain, poor coping, and poor health status, almost all patients with NBS undergoing detoxification were able to stop using narcotics and have significant improvement in pain and coping. However, almost ½ reverted to narcotic use at 3 months. Those who stayed off narcotics showed greater improvement in pain scores. This study provides a rationale for treating patients with NBS by detoxification in order to improve their clinical status. Further work is needed to understand the reasons for the high recidivism rate.

Development and validation of the irritable bowel syndrome satisfaction with care scale.

BACKGROUND & AIMS: Satisfaction with care is an important measure of quality, from the patients' perspective, and could also affect outcomes. However, there is no standard measure of patient satisfaction for irritable bowel syndrome (IBS) care; a multi-item, condition-specific instrument is needed. METHODS: Using standard qualitative methods, we conducted focus groups to identify items that patients associated with satisfaction in their care for IBS. These and additional items identified by experts were placed into a preliminary questionnaire, which was refined through pilot testing and cognitive debriefing by additional patients, as well as standard statistical methods. The resulting instrument and several external validation measures were administered to 300 adult US patients with IBS. Factor analysis was performed to identify clinically relevant subscales and then psychometric properties were assessed. RESULTS: We developed an IBS satisfaction with care scale (IBS-SAT) that has 38 items from 5 clinically relevant subscales (connection with provider, education, benefits of visit, office attributes, and access to care). This IBS-SAT had a high level of internal consistency (Crohnbach's α = .96). Convergent validity was established by correlations between the IBS-SAT and a single, global satisfaction with care question (r = 0.68; P < .001), and a generic, multi-item satisfaction scale (physician satisfaction questionnaire-18) (r = 0.75, P < .001). Discriminant validity (among known groups) was established across groups that were stratified based on IBS-quality of life (r = 0.34; P < .0001), IBS severity (functional bowel disorders severity index) (r = -0.21; P < .001), and number of unmet expectations (r = -0.38; P < .0001). CONCLUSIONS: The IBS-SAT is a validated measure of patient satisfaction with IBS care. As a new, condition-specific instrument, it is likely to be a useful tool for quality measurement, health services research, and clinical trials.