Anal Injectable and Implantable Bulking Agents for Faecal Incontinence

Camilleri-Brennan, John

doi:10.5772/intechopen.91952

Cited by 3 publications

(14 citation statements)

References 21 publications

(27 reference statements)

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“…The operative technique has been described elsewhere [ 15 ]. Using a custom THD Gatekeeper™ Delivery System (THD SpA, Correggio, Italy) and dispenser the GK prostheses are placed in the intersphincteric space of the mid to upper anal canal.…”

Section: Methodsmentioning

confidence: 99%

An evaluation of the long-term effectiveness of Gatekeeper™ intersphincteric implants for passive faecal incontinence

Jabbar

Camilleri-Brennan

2022

Tech Coloproctol

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Background Implantation of Gatekeeper™ prostheses presents an option for the treatment of passive faecal incontinence (FI). Whilst preliminary results are encouraging, long-term data regarding its sustained benefit are limited. The aim of this study was to assess and evaluate the long-term clinical function and quality of life of patients with passive faecal incontinence who were treated with Gatekeeper™ prostheses. Methods This was a single centre, single surgeon retrospective study of prospectively collected clinical data in patients with FI treated between June 2012 and May 2019. Patients with passive FI with symptoms refractory to conservative treatment and endoanal ultrasonography showing intact or disrupted internal anal sphincter were included. Formal clinical and quality of life assessments were carried out using the St. Mark’s Incontinence Score (SMIS) and Faecal Incontinence Quality of Life (FIQoL) questionnaires at baseline, 3 months, 6 months, 12 months and then annually. Endoanal ultrasonography was performed both before and after surgery. Results Forty patients (14 males, 26 females) with a median age of 62.5 (range 33–80) years were treated with the Gatekeeper™ implant. The majority of patients (87.5%) received six implants. There were no peri or post-operative complications. Prosthesis migration was observed in 12.5% patients. The median follow-up duration was 5 years (interquartile range (IQR) 3.25–6.00 years). A sustained improvement in median SMIS and FIQoL scores from baseline to follow-up was noted. Significant differences were observed between the median baseline SMIS score and last follow-up score of 16.00 (IQR 15.00–16.75) to 7.00 (IQR 5.00–8.00) respectively (p < 0.001), a 56.25% decrease. The overall median FIQoL score showed a significant improvement from 7.95 (IQR 7.13–9.48) to 13.15 (IQR 12.00–13.98) (p < 0.001) a 65.40% increase. Conclusions Gatekeeper™ implantation is a safe approach to treating passive FI and is minimally invasive, reproducible and has minimal complications. Long-term sustained clinical improvement is achievable beyond 5 years. Careful patient selection is paramount, as is consistency of technique and follow-up protocol.

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Section: Methodsmentioning

confidence: 99%

An evaluation of the long-term effectiveness of Gatekeeper™ intersphincteric implants for passive faecal incontinence

Jabbar

Camilleri-Brennan

2022

Tech Coloproctol

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“…Faecal incontinence (FI), a highly prevalent condition, is the involuntary loss of intestinal contents due to an impaired ability to control the release of faeces/flatus [1][2][3]. Patients with FI suffer from a complex health problem causing considerable physical and social impairments leading to massive limitations in the quality of life (QoL) due to isolation, shame, and social rejection [4].…”

Section: Introductionmentioning

confidence: 99%

“…Patients with FI suffer from a complex health problem causing considerable physical and social impairments leading to massive limitations in the quality of life (QoL) due to isolation, shame, and social rejection [4]. These stigmatising conditions adversely affect psychological well-being [3,[5][6][7]. The prevalence is estimated to 2-20% in the adult population and increases with age [6,7].…”

Section: Introductionmentioning

confidence: 99%

“…Injectable bulking agents, i.e. non-self-expandable prostheses, such as Solesta ® , Bulkamid ™ , PTQ ™ , Durasphere ® , and Permacol ™ , are injected around or into the anal canal [3,4]. The main clinical indication for injectable bulking agents is IAS disruption/dysfunction, causing passive FI [3].…”

Section: Introductionmentioning

confidence: 99%

“…non-self-expandable prostheses, such as Solesta ® , Bulkamid ™ , PTQ ™ , Durasphere ® , and Permacol ™ , are injected around or into the anal canal [3,4]. The main clinical indication for injectable bulking agents is IAS disruption/dysfunction, causing passive FI [3]. Bulking agents' injections vary depending on the clinical indication and type of substance used [3].…”

Section: Introductionmentioning

confidence: 99%

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Clinical effectiveness and safety of self-expandable implantable bulking agents for faecal incontinence: a systematic review

2022

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Purpose The purpose of this systematic review is to evaluate whether self-expandable implantable vs non-self-expandable injectable bulking agents (second-line therapies) are equal/superior in terms of effectiveness (severity, quality of life [QoL]) and safety (adverse events) for faecal incontinence (FI). Methods A systematic review was conducted, and five databases were searched (Medline via Ovid, Embase, Cochrane Library, University of York Centre for Reviews and Dissemination, and International Network of Agencies for Health Technology database). In-/exclusion criteria were predefined according to the PICOS scheme. The Institute of Health Economics risk of bias (RoB) tool assessed studies' internal validity. According to the Grading of Recommendations, Assessment, Development and Evaluation approach, the strength of evidence for safety outcomes was rated. A qualitative synthesis of the evidence was used to analyse the data. Results The evidence consists of eight prospective single-arm, before-after studies (166 patients) fulfilling the inclusion criteria for assessing clinical effectiveness and safety of implantable bulking agents. FI severity statistically significantly improved in five of seven studies rated by the Cleveland Clinic FI Score and in three of five studies measured by the Vaizey score. Statistically significant improved disease-related QoL was found in one of five studies measured by the FI QoL Score and in one of two studies rated by the American Medical Systems score. Procedure-related adverse events occurred in 16 of 166 patients (i.e., intraoperative complications, anal discomfort and pain). Device-related adverse events occurred in 48 of 166 patients, including prostheses’ dislodgement and removed/extruded prostheses. Studies were judged with moderate/high RoB. The strength of evidence for safety was judged to be very low. Conclusion Implantable bulking agents might be an effective and safe minimally invasive option in FI treatment if conservative therapies fail. FI severity significantly improved, however, effects on QoL need to be explored in further studies. Due to the uncontrolled nature of the case series, comparative studies need to be awaited.

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Fecal Incontinence: From Anatomy to Recent Advances

Chalise,

Bhattacharya,

P. Kandel

2023

Anorectal Disorders - From Diagnosis to Treatment

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The anatomy and physiology of the pelvic floor are complex. A thorough understanding of the anatomy is required to understand how we attain physiological continence. Fecal incontinence can be a life-altering condition that presents as an inability to maintain voluntary control of the passage of gas, liquid, or solid stool through the anus in patients who previously had control. The key to successfully managing a patient with fecal incontinence is to identify the underlying cause. There have been many prescribed procedures for patients requiring surgical correction to attain continence. However, the results are dismal for many patients. Recent advances have challenged these procedures with higher success rates.

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Anal Injectable and Implantable Bulking Agents for Faecal Incontinence

Cited by 3 publications

References 21 publications

An evaluation of the long-term effectiveness of Gatekeeper™ intersphincteric implants for passive faecal incontinence

An evaluation of the long-term effectiveness of Gatekeeper™ intersphincteric implants for passive faecal incontinence

Clinical effectiveness and safety of self-expandable implantable bulking agents for faecal incontinence: a systematic review

Fecal Incontinence: From Anatomy to Recent Advances

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