Different faces of gastroparesis

AIM： To test the hypothesis that pain and affect rather than impaired emptying determine symptom severity in patients with gastroparesis. METHODS： Adult patients with documented gastroparesis were enrolled prospectively in a single center and asked to complete the Gastroparesis Cardinal Symptom Index （GCSt）, Hospital Anxiety and Depression Scale （HADS）, the Short Form 12 （SF-12） as quality of life index, rate pain severity and answer 10 open-ended questions. RESULTS： A total of 55 patients （44 women） participated. Idiopathic （n = 29） or diabetic （n = 11） gastroparesis and connective tissue disease （n = 8） were the most common underlying causes. Antiemetics （n = 30） and prokinetics （n = 32） were most often prescribed. Seventeen patients used opioids on a daily basis. Nausea and/or vomiting （n = 28）, pain （n = 24） and bloating （n = 14） were most commonly listed as dominant symptoms. Patients subjectively attributed symptom improvement to nutritional and dietary therapy （n= 11）, prokinetics （n = 11）, antiemetics （n = 10） or analgesic agents （n = 3）. In univariate analyses, the physical subscore of the SF-12 and HADS, but not gastric emptying delay or symptom duration significantly correlated with disease severity as measured by the GCSI. In multivariate analyses, the combination of vomiting, bloating and depression best predicted the overall impact on quality of life. CONCLUSION： The study confirms the importance of pain and affect in gastroparesis, which requires novel approaches to improve more effectively the quality of life in patients with this disorder.

Adverse events of sacral neuromodulation for fecal incontinence reported to the federal drug administration

AIM:To investigate the nature and severity of AE related to sacral neurostimulation(SNS).METHODS:Based on Pubmed and Embase searches,we identified published trials and case series of SNS for fecal incontinence(FI)and extracted data on adverse events,requiring an active intervention.Those problems were operationally defined as infection,device removal explant or need for lead and/or generator replacement.In addition,we analyzed the Manufacturer and User Device Experience registry of the Federal Drug Administration for the months of August-October of2015.Events were included if the report specifically mentioned gastrointestinal(GI),bowel and FI as indication and if the narrative did not focus on bladder symptoms.The classification,reporter,the date of the recorded complaint,time between initial implant and report,the type of AE,steps taken and outcome were extracted from the report.In cases of device removal or replacement,we looked for confirmatory comments by healthcare providers or the manufacturer.RESULTS:Published studies reported adverse events and reoperation rates for 1954 patients,followed for 27(1-117)mo.Reoperation rates were 18.6%(14.2-23.9)with device explants accounting for 10.0%(7.8-12.7)of secondary surgeries;rates of device replacement or explant or pocket site and electrode revisions increased with longer follow up.During the period examined,the FDA received 1684 reports of AE related to SNS with FI or GI listed as indication.A total of 652 reports met the inclusion criteria,with 52.7%specifically listing FI.Lack or loss of benefit(48.9%),pain or dysesthesia(27.8%)and complication at the generator implantation site(8.7%)were most commonly listed.Complaints led to secondary surgeries in 29.7%of the AE.Reoperations were performed to explant(38.2%)or replace(46.5%)the device or a lead,or revise the generator pocket(14.6%).Conservative management changes mostly involved changes in stimulation parameters(44.5%),which successfully addressed concerns in 35.2%of cases that included information about treatment results.CONCLUSION:With reoperation rates around 20%,physicians need to fully disclose the high likelihood ofcomplications and secondary interventions and exhaust non-invasive treatments,including transcutaneous stimulation paradigms.