Use of a new transanal irrigation device for bowel disorder management by patients familiar with the irrigation technique: a prospective, interventional, multicenter pilot study.
Balloon catheter
Efficacy
Electric pump
Safety
Transanal irrigation
Journal
Techniques in coloproctology
ISSN: 1128-045X
Titre abrégé: Tech Coloproctol
Pays: Italy
ID NLM: 9613614
Informations de publication
Date de publication:
07 2020
07 2020
Historique:
received:
13
10
2019
accepted:
06
04
2020
pubmed:
23
4
2020
medline:
28
4
2021
entrez:
23
4
2020
Statut:
ppublish
Résumé
The aim of this study was to evaluate the feasibility of transanal irrigation (TAI) with a new medical device incorporating an electric pump, the IryPump®R Set. An interventional, prospective, open-label, non-comparative, multicenter pilot study on TAI was conducted at three French university hospitals. Patients with experience of TAI were enrolled for a 1-month period during which 5 consecutive TAIs were performed using the IryPump®R Set (B.Braun Melsungen AG Melsungen, Germany). The study's primary efficacy criterion was successful TAI, defined as (i) use of the patient's usual irrigation volume of water, (ii) stool evacuation, and (iii) the absence of leakage between TAIs. The first two TAIs were not taken into account in the main analysis. The secondary outcome measures were device acceptability, bowel dysfunction scores, tolerability, and safety. Fifteen patients were included between November 2016 and May 2017, and 14 were assessed in the main analysis. The TAI success rate was 72.4% (21 out of 29 procedures). The bowel dysfunction scores at the end of the study did not differ significantly from those recorded on inclusion. A high proportion of patients (> 70%) reported that TAI was feasible with the new medical device. There were no serious adverse events or device-related adverse events. At the end of the study, 50% of the participants were willing to consider further use of the new device. In patients familiar with TAI, using a new medical device incorporating an electric pump was feasible. Levels of patient satisfaction were high, especially with regard to comfort of use and a feeling of security during TAI.
Sections du résumé
BACKGROUND
The aim of this study was to evaluate the feasibility of transanal irrigation (TAI) with a new medical device incorporating an electric pump, the IryPump®R Set.
METHODS
An interventional, prospective, open-label, non-comparative, multicenter pilot study on TAI was conducted at three French university hospitals. Patients with experience of TAI were enrolled for a 1-month period during which 5 consecutive TAIs were performed using the IryPump®R Set (B.Braun Melsungen AG Melsungen, Germany). The study's primary efficacy criterion was successful TAI, defined as (i) use of the patient's usual irrigation volume of water, (ii) stool evacuation, and (iii) the absence of leakage between TAIs. The first two TAIs were not taken into account in the main analysis. The secondary outcome measures were device acceptability, bowel dysfunction scores, tolerability, and safety.
RESULTS
Fifteen patients were included between November 2016 and May 2017, and 14 were assessed in the main analysis. The TAI success rate was 72.4% (21 out of 29 procedures). The bowel dysfunction scores at the end of the study did not differ significantly from those recorded on inclusion. A high proportion of patients (> 70%) reported that TAI was feasible with the new medical device. There were no serious adverse events or device-related adverse events. At the end of the study, 50% of the participants were willing to consider further use of the new device.
CONCLUSIONS
In patients familiar with TAI, using a new medical device incorporating an electric pump was feasible. Levels of patient satisfaction were high, especially with regard to comfort of use and a feeling of security during TAI.
Identifiants
pubmed: 32318989
doi: 10.1007/s10151-020-02212-x
pii: 10.1007/s10151-020-02212-x
pmc: PMC7297826
doi:
Types de publication
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
731-740Commentaires et corrections
Type : ErratumIn
Références
Awad RA (2011) Neurogenic bowel dysfunction in patients with spinal cord injury, myelomeningocele, multiple sclerosis and Parkinson's disease. World J Gastroenterol 17(46):5035–5048. https://doi.org/10.3748/wjg.v17.i46.5035
doi: 10.3748/wjg.v17.i46.5035
pubmed: 3235587
Yde J, Larsen HM, Laurberg S, Krogh K, Moeller HB (2018) Chronic diarrhoea following surgery for colon cancer-frequency, causes and treatment options. Int J Colorectal Dis 33(6):683–694. https://doi.org/10.1007/s00384-018-2993-y
doi: 10.1007/s00384-018-2993-y
Krassioukov A, Eng JJ, Claxton G, Sakakibara BM, Shum S (2010) Neurogenic bowel management after spinal cord injury: a systematic review of the evidence. Spinal Cord 48(10):718–733. https://doi.org/10.1038/sc.2010.14
doi: 10.1038/sc.2010.14
pubmed: 3118252
Henderson M, Tinkler L, Yiannakou Y (2018) Transanal irrigation as a treatment for bowel dysfunction. Gastrointestinal Nurs. https://doi.org/10.12968/gasn.2018.16.4.26
doi: 10.12968/gasn.2018.16.4.26
Christensen P, Krogh K (2010) Transanal irrigation for disordered defecation: a systematic review. Scand J Gastroenterol 45(5):517–527. https://doi.org/10.3109/00365520903583855
doi: 10.3109/00365520903583855
Wilson M (2017) A review of transanal irrigation in adults. Br J Nurs 26(15):846–856. https://doi.org/10.12968/bjon.2017.26.15.846
doi: 10.12968/bjon.2017.26.15.846
Emmanuel AV, Krogh K, Bazzocchi G, Leroi AM, Bremers A, Leder D, van Kuppevelt D, Mosiello G, Vogel M, Perrouin-Verbe B, Coggrave M, Christensen P, Members of working group on Trans Anal Irrigation from Uk DIGF, Netherlands (2013) Consensus review of best practice of transanal irrigation in adults. Spinal Cord 51(10):732–738. https://doi.org/10.1038/sc.2013.86
doi: 10.1038/sc.2013.86
pubmed: 23958927
Dale M, Morgan H, Carter K, White J, Carolan-Rees G (2019) Peristeen transanal irrigation system to manage bowel dysfunction: a NICE medical technology guidance. Appl Health Econ Health Policy 17(1):25–34. https://doi.org/10.1007/s40258-018-0447-x
doi: 10.1007/s40258-018-0447-x
pubmed: 30426450
Martellucci J, Sturiale A, Bergamini C, Boni L, Cianchi F, Coratti A, Valeri A (2018) Role of transanal irrigation in the treatment of anterior resection syndrome. Tech Coloproctol 22(7):519–527. https://doi.org/10.1007/s10151-018-1829-7
doi: 10.1007/s10151-018-1829-7
pubmed: 30083782
Gosselink MP, Darby M, Zimmerman DD, Smits AA, van Kessel I, Hop WC, Briel JW, Schouten WR (2005) Long-term follow-up of retrograde colonic irrigation for defaecation disturbances. Colorectal Dis 7(1):65–69. https://doi.org/10.1111/j.1463-1318.2004.00696.x
doi: 10.1111/j.1463-1318.2004.00696.x
pubmed: 15606588
Vollebregt PF, Elfrink AK, Meijerink WJ, Felt-Bersma RJ (2016) Results of long-term retrograde rectal cleansing in patients with constipation or fecal incontinence. Tech Coloproctol 20(9):633–639. https://doi.org/10.1007/s10151-016-1502-y
doi: 10.1007/s10151-016-1502-y
pubmed: 27380257
Passananti V, Wilton A, Preziosi G, Storrie JB, Emmanuel A (2016) Long-term efficacy and safety of transanal irrigation in multiple sclerosis. Neurogastroenterol Motil 28(9):1349–1355. https://doi.org/10.1111/nmo.12833
doi: 10.1111/nmo.12833
pubmed: 27117939
Bildstein C, Melchior C, Gourcerol G, Boueyre E, Bridoux V, Verin E, Leroi AM (2017) Predictive factors for compliance with transanal irrigation for the treatment of defecation disorders. World J Gastroenterol 23(11):2029–2036. https://doi.org/10.3748/wjg.v23.i11.2029
doi: 10.3748/wjg.v23.i11.2029
pubmed: 28373769
Emmanuel A (2010) Review of the efficacy and safety of transanal irrigation for neurogenic bowel dysfunction. Spinal Cord 48(9):664–673. https://doi.org/10.1038/sc.2010.5
doi: 10.1038/sc.2010.5
pubmed: 20142830
Gallo G, Graziani S, Luc AR, Clerico G, Trompetto M (2018) Teaching TransAnal Irrigation (TAI): why it is mandatory. Tech Coloproctol 22(3):239–241. https://doi.org/10.1007/s10151-018-1768-3
doi: 10.1007/s10151-018-1768-3
pubmed: 29527622
Christensen P, Krogh K, Buntzen S, Payandeh F, Laurberg S (2009) Long-term outcome and safety of transanal irrigation for constipation and fecal incontinence. Dis Colon Rectum 52(2):286–292. https://doi.org/10.1007/DCR.0b013e3181979341
doi: 10.1007/DCR.0b013e3181979341
pubmed: 19279425
Shaw L (2018) Transanal irrigation for bowel dysfunction: the role of the nurse. Br J Nurs 27(21):1226–1230. https://doi.org/10.12968/bjon.2018.27.21.1226
doi: 10.12968/bjon.2018.27.21.1226
pubmed: 30457370
Christensen P, Bazzocchi G, Coggrave M, Abel R, Hultling C, Krogh K, Media S, Laurberg S (2006) A randomized, controlled trial of transanal irrigation versus conservative bowel management in spinal cord-injured patients. Gastroenterology 131(3):738–747. https://doi.org/10.1053/j.gastro.2006.06.004
doi: 10.1053/j.gastro.2006.06.004
pubmed: 16952543
Agachan F, Chen T, Pfeifer J, Reissman P, Wexner SD (1996) A constipation scoring system to simplify evaluation and management of constipated patients. Dis Colon Rectum 39(6):681–685
doi: 10.1007/BF02056950
Vaizey CJ, Carapeti E, Cahill JA, Kamm MA (1999) Prospective comparison of faecal incontinence grading systems. Gut 44(1):77–80
doi: 10.1136/gut.44.1.77
pubmed: 9862829
Krogh K, Christensen P, Sabroe S, Laurberg S (2006) Neurogenic bowel dysfunction score. Spinal Cord 44(10):625–631. https://doi.org/10.1038/sj.sc.3101887
doi: 10.1038/sj.sc.3101887
pubmed: 16344850
Christensen P, Bazzocchi G, Coggrave M, Abel R, Hulting C, Krogh K, Media S, Laurberg S (2008) Outcome of transanal irrigation for bowel dysfunction in patients with spinal cord injury. J Spinal Cord Med 31(5):560–567
doi: 10.1080/10790268.2008.11754571
pubmed: 19086714
Hamonet-Torny J, Bordes J, Daviet JC, Dalmay F, Joslin F, Salle JY (2013) Long-term transanal irrigation's continuation at home. Preliminary study. Ann Phys Rehabil Med 56(2):134–142. https://doi.org/10.1016/j.rehab.2013.01.005
doi: 10.1016/j.rehab.2013.01.005
pubmed: 23462338
Juul T, Christensen P (2017) Prospective evaluation of transanal irrigation for fecal incontinence and constipation. Tech Coloproctol 21(5):363–371. https://doi.org/10.1007/s10151-017-1635-7
doi: 10.1007/s10151-017-1635-7
pubmed: 28550422