Fecal incontinence following anterior resection and neoadjuvant therapy should be carefully evaluated. If a suspected neurogenic pathogenesis is confirmed, sacral neuromodulation may be proposed. If the test results are positive, permanent implant is advisable. Failure of this approach does not exclude the use of other, more aggressive treatment.
IntroductionA new artificial anal sphincter, SphinKeeperTM, was devised with the aim to treat fecal incontinence (FI) by implanting specifically designed self-expandable prostheses into the intersphincteric space. Preliminary data concerning the procedure feasibility and prosthesis localization at 3 months are presented.MethodsSphinKeeperTM prostheses in the native state are dehydrated, thin, solid cylinder (length 29 mm, diameter 3 mm), changing their state (shorter—length 23 mm, thicker—diameter 7 mm—and softer, with shape memory) within 48 h of contact with fluids. In this study, 10 prostheses were implanted in each patient with FI under local anesthesia and under endoanal ultrasound (EAUS) guidance, into the upper-middle intersphincteric space of the anal canal by a specifically designed delivery system. EAUS was used postoperatively to assess prostheses dislocation.ResultsTen patients (5 females; median age 58 years, range 20–75) were enrolled and treated with SphinKeeperTM implantation. Median duration of procedure (performed by endoanal ultrasound guidance) was 40 min (range 30–45). Neither intraoperative nor postoperative complications were reported after a 3-month follow-up. In one patient, a partial dislocation of a single prosthesis was documented by EAUS, causing anal discomfort which resolved after 1 week.ConclusionSphinKeeperTM can be safely implanted in patients with FI of different etiology. Implantation was well tolerated with no dislodgment of implants at 3-month follow-up.
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.
These data highlight the diagnostic accuracy of EAUS, particularly when hydrogen peroxide injection or 3-D imaging are used. Basing our surgical decision making on EAUS findings allowed us to carry out curative operations in a significantly large number of patients; the recurrence rate was very low. The accurate EAUS assessment of the relationship between fistulas and sphincters has been the main factor in choosing a sphincter-saving surgical procedure, avoiding fecal incontinence.
BackgroundVarious injectable bulking agents have been used for the treatment of faecal incontinence (FI). However, encouraging early results are not maintained over time. This study aimed to assess short- and medium-term results of a new bulking agent for the treatment of FI.MethodsThe Gatekeeper™ prosthesis comprises a thin solid polyacrylonitrile cylinder that becomes thicker, shorter and softer within 24 h after implantation. Fourteen patients with FI underwent treatment with Gatekeeper™ under local anaesthesia. Four prostheses were implanted in the intersphincteric space in each patient, under endoanal ultrasound guidance. Number of episodes of major FI, Cleveland Clinic FI score (CCFIS), Vaizey score, anorectal manometry, endoanal ultrasonography (EUS), health status and quality of life (Short Form 36 and Faecal Incontinence Quality of Life questionnaires) were assessed before and after treatment.ResultsMean(s.d.) follow-up was 33·5(12·4) months. There were no complications. There was a significant decrease in major FI episodes from 7·1(7·4) per week at baseline to 1·4(4·0), 1·0(3·2) and 0·4(0·6) per week respectively at 1-month, 3-month and last follow-up (P = 0·002). CCFIS improved significantly from 12·7(3·3) to 4·1(3·0), 3·9(2·6) and 5·1(3·0) respectively (P < 0·001), and Vaizey score from 15·4(3·3) to 7·1(3·9), 4·7(3·0) and 6·9(5·0) respectively (P = 0·010). Soiling and ability to postpone defaecation improved significantly, and patients reported significant improvement in health status and quality of life. At follow-up, manometric parameters had not changed and EUS did not demonstrate any prosthesis dislocation.ConclusionThe Gatekeeper™ anal implant seemed safe, reliable and effective. Initial clinical improvement was maintained over time, and follow-up data were encouraging. Copyright © 2011 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.
These data appear to confirm that sacral nerve stimulation could represent a valid alternative in the treatment of fecal incontinence patients presenting with sphincter lesion that was not preceded by sphincteroplasty.
BackgroundManagement of anal fistula (AF) remains challenging with many controversies. The purpose of this study was to explore current surgical practice in the management of AF with a focus on technical variations among surgeons.MethodsAn online survey was conducted by inviting all surgeons and physicians on the membership directory of European Society of Coloproctology and American Society of Colon and Rectal Surgeons. An invitation was extended to others via social media. The survey had 74 questions exploring diagnostic and surgical techniques.ResultsIn March 2018, 3572 physicians on membership directory were invited to take part in the study 510 of whom (14%) responded to the survey. Of these respondents, 492 (96%) were surgeons. Respondents were mostly colorectal surgeons (84%) at consultant level (84%), age ≥ 40 years (64%), practicing in academic (53%) or teaching (30%) hospitals, from the USA (36%) and Europe (34%). About 80% considered fistulotomy as the gold standard treatment for simple fistulas. Endorectal advancement flap was performed using partial- (42%) or full-thickness (44%) flaps. Up to 38% of surgeons performed ligation of the intersphincteric fistula tract (LIFT) sometimes with technical variations. Geographic and demographic differences were found in both the diagnostic and therapeutic approaches to AF. Declared rates of recurrence and fecal incontinence with these techniques were variable and did not correlate with surgeons’ experience. Only 1–4% of surgeons were confident in performing the most novel sphincter-preserving techniques in patients with Crohn’s disease.ConclusionsProfound technical variations exist in surgical management of AF, making it difficult to reproduce and compare treatment outcomes among different centers.Electronic supplementary materialThe online version of this article (10.1007/s10151-019-02051-5) contains supplementary material, which is available to authorized users.
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