Efficacy of dextranomer in stabilised hyaluronic acid for treatment of faecal incontinence: a randomised, sham-controlled trial

Graf, Wilhelm; Mellgren, Anders; Matzel, Klaus E.; Hull, Tracy L.; Johansson, Claes; Bernstein, Mitch

doi:10.1016/s0140-6736(10)62297-0

Cited by 215 publications

(197 citation statements)

References 25 publications

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“…The therapeutic approaches currently available range from non‐surgical options, including rehabilitation and biofeedback, to numerous surgical interventions with different levels of technical complexity1. Among the minimally invasive treatments, injectable bulking agents have been used extensively2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18. However, the results are still controversial, resulting in some scepticism and disillusion19, 20, 21, 22, 23.…”

Section: Introductionmentioning

confidence: 99%

Multicentre observational study of the Gatekeeper™ for faecal incontinence

Ratto

Buntzen

Aigner

et al. 2016

Journal of British Surgery

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BackgroundA variety of therapeutic approaches are available for faecal incontinence. Implantation of Gatekeeper™ prostheses is a new promising option. The primary endpoint of this prospective observational multicentre study was to assess the clinical efficacy of Gatekeeper™ implantation in patients with faecal incontinence. Secondary endpoints included the assessment of patients' quality of life, and the feasibility and safety of implantation.MethodsPatients with faecal incontinence, with either intact sphincters or internal anal sphincter lesions extending for less than 60° of the anal circumference, were selected. Intersphincteric implantation of six prostheses was performed. At baseline, and 1, 3 and 12 months after implantation, the number of faecal incontinence episodes, Cleveland Clinic Faecal Incontinence, Vaizey and American Medical Systems, Faecal Incontinence Quality of Life Scale and Short Form 36 Health Survey scores were recorded. Endoanal ultrasonography was performed at baseline and follow‐up.ResultsFifty‐four patients were implanted. After Gatekeeper™ implantation, incontinence to gas, liquid and solid stool improved significantly, soiling was reduced, and ability to defer defaecation enhanced. All faecal incontinence severity scores were significantly reduced, and patients' quality of life improved. At 12 months, 30 patients (56 per cent) showed at least 75 per cent improvement in all faecal incontinence parameters, and seven (13 per cent) became fully continent. In three patients a single prosthesis was extruded during surgery, but was replaced immediately. After implantation, prosthesis dislodgement occurred in three patients; no replacement was required.ConclusionAnal implantation of the Gatekeeper™ in patients with faecal incontinence was effective and safe. Clinical benefits were sustained at 1‐year follow‐up.

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Section: Introductionmentioning

confidence: 99%

Multicentre observational study of the Gatekeeper™ for faecal incontinence

Ratto

Buntzen

Aigner

et al. 2016

Journal of British Surgery

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“…They include sacral nerve stimulation, radiofrequency treatment and surgery. The exact mechanism of action of sacral nerve stimulators is not fully understood, but it is thought to be related to improved ano-rectal angulation and amplification of anal closing pressures [10] . Radiofrequency treatment causes a topical burn with subsequent remodeling and tightening of the ano-rectal muscles and has shown conflicting results in the management of FI [11] .…”

Section: Discussionmentioning

confidence: 99%

“…Hyaluronic acid/dextranomer (Solesta, Salix) applied through transanal submucosal injection provides support for the ingrowth of fibroblasts and collagen [17] . The 12-mo efficacy and safety of this ano-rectal bulking agent has been demonstrated in trials [10,18] . A recent study by La Torre et al [19] demonstrated the efficacy and durability of a hyaluronic acid/dextrano- mer agent 24 mo after use.…”

Section: Discussionmentioning

confidence: 99%

Endoscopic and imaging appearance after injection of an ano-rectal bulking agent

Papafragkakis¹

2014

WJGE

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The use of hyaluronic acid and dextranomer (Solesta, Salix) injection in the anal canal is an emerging modality in the treatment of fecal incontinence. However, little is known regarding the endoscopic and radiological appearance following injection of this ano-rectal bulking agent. We report computed tomography and endoscopic findings after hyaluronic acid/dextranomer injection in the ano-rectal area.© 2014 Baishideng Publishing Group Inc. All rights reserved.Key words: Fecal incontinence; Ano-rectal bulking agent; Hyaluronic acid; Dextranomer Core tip: The use of hyaluronic acid and dextranomer (Solesta, Salix) injection in the ano-rectum is an emerging modality in the treatment of fecal incontinence. Our case discusses the endoscopic and radiological findings after injection of this bulking agent in the ano-rectal area.Papafragkakis H, Changela K, Bhatia T, Ona MA, Malieckal A, Paleti V, Fuksbrumer MS, Anand S. Endoscopic and imaging appearance after injection of an ano-rectal bulking agent. World J Gastrointest Endosc 2014; 6(7): 324-327 Available from: URL:

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“…A randomized sham-controlled trial in 278 patients demonstrated that 52% of patients who received the injectable product experienced 50% or greater improvement in the number of incontinence episodes compared with 32% in the sham group. 34 This agent was recently approved by the US Food and Drug Administration and is available to patients.…”

Section: Review Articlementioning

confidence: 99%