scholarly journals An open prospective study on the efficacy of Navina Smart, an electronic system for transanal irrigation, in neurogenic bowel dysfunction

PLoS ONE ◽  
2021 ◽  
Vol 16 (1) ◽  
pp. e0245453
Author(s):  
Anton Emmanuel ◽  
Ines Kurze ◽  
Klaus Krogh ◽  
Maria Elena Ferreiro Velasco ◽  
Peter Christensen ◽  
...  

Background Transanal irrigation (TAI) has emerged as a key option when more conservative bowel management does not help spinal cord injured (SCI) individuals with neurogenic bowel dysfunction (NBD). Aim To investigate the short-term efficacy and safety of an electronic TAI system (Navina Smart) in subjects with NBD. Design We present an open, prospective efficacy study on Navina Smart, in individuals with NBD secondary to SCI, studied at three months. Population Eighty-nine consecutive consenting established SCI individuals (61 male; mean age 48, range 18–77) naïve to TAI treatment were recruited from ten centres in seven countries. Subjects had confirmed NBD of at least moderate severity (NBD score ≥10). Methods Subjects were taught how to use the device at baseline assisted by the Navina Smart app, and treatment was tailored during phone calls until optimal TAI regime was achieved. The NBD score was measured at baseline and at three months follow up (mean 98 days). Safety analysis was performed on the complete population while per protocol (PP) analysis was performed on 52 subjects. Results PP analysis showed a significant decrease in mean NBD score (17.8 to 10, p<0.00001). In subjects with severe symptoms (defined as NBD score ≥14), mean NBD scores decreased (19.4 to 10.9, p<0.0001). The number of subjects with severe symptoms decreased from 41 (79%) subjects at baseline to 16 (31%) at three months follow-up. Device failure accounted for the commonest cause for loss of data. Side effects possibly related to the device developed in 11 subjects (12%). Discontinuation due to failure of therapy to relieve symptoms was reported by 5 subjects (6%). Conclusion Navina Smart is effective for individuals with NBD, even those with severe symptoms; long-term data will follow. Whilst there were some device problems (addressed by the later stages of subject recruitment) the treatment was generally safe. Clinical trial (ClinicalTrials.gov number NCT02979808)

2015 ◽  
Vol 18 (7) ◽  
pp. A360 ◽  
Author(s):  
A Emmanuel ◽  
P Christensen ◽  
G Kumar ◽  
V Passananti ◽  
S Mealing ◽  
...  

PLoS ONE ◽  
2016 ◽  
Vol 11 (8) ◽  
pp. e0159394 ◽  
Author(s):  
Anton Emmanuel ◽  
Gayathri Kumar ◽  
Peter Christensen ◽  
Stuart Mealing ◽  
Zenia M. Størling ◽  
...  

Spinal Cord ◽  
2007 ◽  
Vol 45 (9) ◽  
pp. 621-626 ◽  
Author(s):  
S Seoane-Rodríguez ◽  
J Sánchez R-Losada ◽  
A Montoto-Marqués ◽  
S Salvador-de la Barrera ◽  
M E Ferreiro-Velasco ◽  
...  

2008 ◽  
Vol 99 (1) ◽  
pp. 7-13
Author(s):  
Ryosuke Takahashi ◽  
Yasusuke Kimoto

2020 ◽  
Vol 37 (6) ◽  
pp. 456-462
Author(s):  
Alice Weréen ◽  
Martin Dahlberg ◽  
Göran Heinius ◽  
Emil Pieniowski ◽  
Deborah Saraste ◽  
...  

<b><i>Objective:</i></b> We aimed to evaluate long-term results in patients from regular health care treated with endoscopic transanal closure system, that is, endoscopic vacuum-assisted closure system (EVAC) compared to transanal irrigation. <b><i>Methods:</i></b> In this retrospective, medical chart-based, observational study, we included patients with anastomotic leakage after low anterior resection for rectal cancer from 3 Stockholm hospitals 2006–2016 and compared time to first stoma closure in a Kaplan-Meier model and the proportion of patients who were stoma-free at end of follow-up. <b><i>Results:</i></b> Anastomotic leakage was found in 81 patients who were followed up in median 5.9 years (min–max: 0.53–13). EVAC was used on 14 (17%) patients and transanal irrigation on 34 (42%) patients. The remaining 33 (41%) patients either got a permanent colostomy or were treated only with antibiotics and percutaneous drainage. Treatment with EVAC or transanal irrigation led to similar rates of stoma closure, both when comparing all patients, and when comparing patients with similar defects. At the end of follow-up, 43% of patients treated with EVAC and 50% of patients treated with repeated irrigation were stoma-free (<i>p</i> = 0.75). <b><i>Conclusions:</i></b> We found no evidence of better outcomes in patients treated with EVAC. The study was, however, limited by small sample size.


2019 ◽  
Vol 17 (7) ◽  
pp. 24-30 ◽  
Author(s):  
Anton Emmanuel ◽  
Brigitte Collins ◽  
Michelle Henderson ◽  
Lisa Lewis ◽  
Kelly Stackhouse

Transanal irrigation (TAI), which has emerged as a therapy for patients with bowel dysfunction, can aid emptying of the bowel and help to re-establish control of bowel function by choosing the time and place of evacuation. Because of the ever-growing numbers of TAI systems available, choosing the optimal equipment can be overwhelming. Therefore, a consensus review of best practice from a working party of experts was thought to represent the most appropriate means of arriving at clinically meaningful advice. This led to the production of an article as well as a decision-guide booklet to aid choice of equipment, initiation, patient education, regimen setting and follow-up. These are designed to help healthcare providers initiating TAI to make optimal decisions for each individual patient.


2019 ◽  
Vol 47 (3) ◽  
pp. 242-250 ◽  
Author(s):  
Nicole LT Tan ◽  
John R Sestan

Post-discharge phone calls are a widely used yet suboptimal method of ascertaining recovery of day surgery patients. We compared the efficiency of an automated electronic system of follow-up, the Day Care Anaesthesia Outcomes Recording Registry (DayCOR), and a telephone call system that was standard practice in our non-profit private healthcare organisation in Victoria, Australia. We also surveyed a group of clinicians to assess their acceptance of DayCOR compared with the telephone call system. DayCOR is a web-based system which collects, alerts, manages and analyses patient-reported outcomes. Patients may opt in to respond to a 15-question survey via a link sent by text message or email. DayCOR’s patient response rate was 77.5%, compared with 66.0% for the telephone call system. Both systems collected data on clinical, process, and experience outcomes. Completeness of data collection was 100% using DayCOR compared with 51%–61.4% of data items using the telephone call system. We estimated that replacing our telephone call system with DayCOR to follow up 60,000 day surgery patients a year would represent an annual cost reduction of AUD$101,345 (53%) using manual demographic data entry, and AUD$142,745 (74%) if DayCOR was integrated with the institution’s existing administrative software. Seventy-eight percent of day surgery nurses and 94% of anaesthetists preferred DayCOR to the telephone call system. All anaesthetists surveyed stated that DayCOR provided more valuable feedback, and almost one-fifth had changed their clinical practice as a result. DayCOR’s efficiency and acceptability will allow more effective collection of post-discharge patient outcomes than is currently possible in our institution, and will support interventional studies aimed at improving quality of recovery of day surgery patients.


2017 ◽  
Vol 91 ◽  
pp. 15-21 ◽  
Author(s):  
Cornelia Putz ◽  
Celine D. Alt ◽  
Cornelia Hensel ◽  
Björn Wagner ◽  
Simone Gantz ◽  
...  

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